MedWatch - October 2008 Safety-Related Drug Labeling Changes

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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View

Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Avelox (moxifloxacin hydrochloride) Tablets Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection) Prescribing Information Medication Guide See MedWatch safety alert posted 07/08/2008.	BOXED WARNING (new) WARNINGS Tendinopathy and Tendon Rupture PRECAUTIONS Information for Patients Patients should be advised: to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Avelox treatment. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants... Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Avelox... MEDICATION GUIDE (new)	BOXED WARNING WARNING: Fluoroquinolones, including Avelox, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (See WARNINGS). WARNINGS Tendinopathy and Tendon Rupture: Fluoroquinolones, including Avelox, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Avelox should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

Cipro I.V. (ciprofloxacin) for Intravenous Infusion Prescribing Information Medication Guide See MedWatch safety alert posted 07/08/2008.	BOXED WARNING (new) WARNINGS Tendinopathy and Tendon Rupture PRECAUTIONS Information for Patients Patients should be advised: to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Cipro I.V. treatment. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants... Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Cipro I.V... MEDICATION GUIDE (new)	BOXED WARNING WARNING: Fluoroquinolones, including Cipro I.V., are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (See WARNINGS). WARNINGS Tendinopathy and Tendon Rupture: Fluoroquinolones, including Cipro I.V., are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Cipro I.V. should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

Cipro (ciprofloxacin hydrochloride) Tablets Cipro (ciprofloxacin) Oral Suspension Prescribing Information Medication Guide See MedWatch safety alert posted 07/08/2008.	BOXED WARNING (new) WARNINGS Tendinopathy and Tendon Rupture PRECAUTIONS Information for Patients Patients should be advised: to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Cipro treatment. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants... Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Cipro... MEDICATION GUIDE (new)	BOXED WARNING WARNING: Fluoroquinolones, including Cipro, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (See WARNINGS). WARNINGS Tendinopathy and Tendon Rupture: Fluoroquinolones, including Cipro, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Cipro should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

Cipro XR (ciprofloxacin extended-release tablets) Prescribing Information Medication Guide See MedWatch safety alert posted 07/08/2008.	BOXED WARNING (new) WARNINGS Tendinopathy and Tendon Rupture PRECAUTIONS Information for Patients Patients should be advised: to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Cipro XR treatment. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants... Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Cipro XR... MEDICATION GUIDE (new)	BOXED WARNING WARNING: Fluoroquinolones, including Cipro XR, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (See WARNINGS). WARNINGS Tendinopathy and Tendon Rupture: Fluoroquinolones, including Cipro XR, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Cipro XR should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

Factive (gemifloxacin mesylate) Tablets Prescribing Information Medication Guide See MedWatch safety alert posted 07/08/2008.	BOXED WARNING (new) WARNINGS Tendinopathy and Tendon Rupture PRECAUTIONS Information for Patients Patients should be counseled: to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Factive treatment. The risk of severe tendon disorders with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants... Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Factive... ADVERSE REACTIONS Postmarketing Adverse Reactions Tendon Rupture MEDICATION GUIDE (new)	BOXED WARNING WARNING: Fluoroquinolones, including Factive, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (See WARNINGS). WARNINGS Tendinopathy and Tendon Rupture: Fluoroquinolones, including Factive, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Factive should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

Floxin (ofloxacin) Tablets Prescribing Information Medication Guide See MedWatch safety alert posted 07/08/2008.	BOXED WARNING (new) WARNINGS Tendinopathy and Tendon Rupture PRECAUTIONS Information for Patients Patients should be advised: to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Floxin treatment. The risk of severe tendon disorders with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants... Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Floxin... MEDICATION GUIDE (new)	BOXED WARNING WARNING: Fluoroquinolones, including Floxin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (See WARNINGS). WARNINGS Tendinopathy and Tendon Rupture: Fluoroquinolones, including Floxin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Floxin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

Levaquin (levofloxacin) Tablets and Oral Solution Levaquin (levofloxacin) Injection, for Intravenous Use Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use Prescribing Information (in new labeling format) Medication Guide See MedWatch safety alert posted 07/08/2008.	BOXED WARNING (new) WARNINGS AND PRECAUTIONS Tendinopathy and Tendon Rupture USE IN SPECIFIC POPULATIONS Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Levaquin... PATIENT COUNSELING INFORMATION Serious and Potentially Serious Adverse Reactions Tendon Disorders Patients should contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Levaquin treatment. The risk of severe tendon disorders with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart and lung transplants. MEDICATION GUIDE (new)	BOXED WARNING WARNING: Fluoroquinolones, including Levaquin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart and lung transplants [See Warnings and Precautions (5.1)]. WARNINGS AND PRECAUTIONS Tendinopathy and Tendon Rupture: Fluoroquinolones, including Levaquin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Levaquin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug. [see Adverse Reactions (6.3); Patient Counseling Information (17.3)].

Noroxin (norfloxacin) Tablets Prescribing Information Medication Guide See MedWatch safety alert posted 07/08/2008.	BOXED WARNING (new) WARNINGS Tendinopathy and Tendon Rupture PRECAUTIONS Information for Patients Patients should be advised: to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Noroxin treatment. The risk of severe tendon disorders with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants... Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Noroxin... MEDICATION GUIDE (new)	BOXED WARNING WARNING: Fluoroquinolones, including Noroxin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (See WARNINGS). WARNINGS Tendinopathy and Tendon Rupture: Fluoroquinolones, including Noroxin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Noroxin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

Ontak (denileukin difttox) Solution for Intravenous Use Prescribing Information (in new labeling format)	BOXED WARNING WARNING: SERIOUS INFUSION REACTIONS, CAPILLARY LEAK SYNDROME AND LOSS OF VISUAL ACUITY. WARNINGS AND PRECAUTIONS Infusion Reactions Capillary Leak Syndrome CD25 Tumor Expression and Evaluation ...A testing service for the assay of CD25 expression in tumor biopsy samples is available. For information on this service call 877-873-4724. ADVERSE REACTIONS Clinical Studies Experience Initial Section Table 1 (new) Hepatobiliary Disorders Immunogenicity USE IN SPECIFIC POPULATIONS Nursing Mothers Geriatric Use PATIENT COUNSELING INFORMATION (new)	BOXED WARNING WARNING: SERIOUS INFUSION REACTIONS, CAPILLARY LEAK SYNDROME AND LOSS OF VISUAL ACUITY. The following adverse reactions have been reported: Serious and fatal infusion reactions. Administer Ontak in a facility equipped and staffed for cardiopulmonary resuscitation. Immediately stop and permanently discontinue Ontak for serious infusion reactions [see Warnings and Precautions (5.1)]. Capillary leak syndrome resulting in death. Monitor weight, edema, blood pressure and serum albumin levels prior to and during Ontak treatment [see Warnings and Precautions (5.2)]. Loss of visual acuity and color vision [see Warnings and Precautions (5.3)]. WARNINGS AND PRECAUTIONS Infusion Reactions: Infusion reactions, defined as symptoms occurring within 24 hours of infusion and resolving within 48 hours of the last infusion in that course, were reported in 70.5% (165/234) of Ontak-treated patients across 3 clinical studies utilizing the approved doses and schedule. Serious infusion reactions were reported in 8.1% (19/234) of Ontak-treated patients. There have been post-marketing reports of infusion reactions resulting in death. For patients completing at least 4 courses of Ontak treatment in Study 1 [see Clinical Studies (14.1)], the incidence of infusion reactions was lower in the 3rd and 4th cycles as compared to the 1st and 2nd cycles of Ontak. Resuscitative equipment should be available during Ontak administration. Immediately stop and permanently discontinue Ontak for serious infusion reactions. Capillary Leak Syndrome: Capillary leak syndrome was defined as the occurrence of at least 2 of the following 3 symptoms (hypotension, edema, serum albumin <3.0 g/dL) at any time during Ontak therapy. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome. As defined, capillary leak syndrome was reported in 32.5% (76/234) of Ontak-treated patients. Among these 76 patients with capillary leak syndrome, one-third required hospitalization or medical intervention to prevent hospitalization. There have been post-marketing reports of capillary leak syndrome resulting in death. The onset of symptoms in patients with capillary leak syndrome may be delayed, occurring up to 2 weeks following infusion. Symptoms may persist or worsen after the cessation of Ontak. Regularly assess patients for weight gain, new onset or worsening edema, hypotension (including orthostatic changes) and monitor serum albumin levels prior to the initiation of each course of therapy and more often as clinically indicated. Withhold Ontak for serum albumin levels of less than 3.0 g/dL [see Warnings and Precautions (5.5)].

Raptiva (efalizumab) for Injection, Subcutaneous Prescribing Information Patient Package Insert See MedWatch safety alert posted 10/17/2008.	BOXED WARNING (new) WARNING: RISK OF SERIOUS INFECTIONS WARNINGS Serious Infections Neurologic Events (new subsection) PRECAUTIONS Immunizations Information for Patients Carcinogenesis, Mutagenesis, Impairment of Fertility Pediatric Use ADVERSE REACTIONS Initial Paragraph Infections Postmarketing Experience Infections serious bacterial, fungal, viral and other opportunistic infections, including JC virus resulting in PML... Malignancies lymphoma Neurologic Guillain-Barré Syndrome, chronic inflammatory demyelinating polyneuropathy, transverse myelitis, and facial palsy... PATIENT PACKAGE INSERT Initial Paragraph What is the most important information I should know about Raptiva? What should I avoid while using Raptiva? What are the possible side effects of Raptiva?	BOXED WARNING WARNING: RISK OF SERIOUS INFECTIONS Infections, including serious infections leading to hospitalizations or death, have been observed in patients treated with Raptiva (see WARNINGS and ADVERSE REACTIONS). These infections have included bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections. Patients should be educated about the symptoms of infection and be closely monitored for signs and symptoms of infection during and after treatment with Raptiva. If a patient develops a serious infection, Raptiva should be discontinued and appropriate therapy instituted. Progressive Multifocal Leukoencephalopathy (PML) resulting from JC virus infection has occurred during therapy with Raptiva (see WARNINGS). WARNINGS Serious Infections: Progressive Multifocal Leukoencephalopathy (PML) has been reported in a post-marketing study. Physicians treating patients with Raptiva should consider PML in any patient with new-onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated. Patients being treated with Raptiva should be instructed to report any new neurological signs or symptoms to their physician. Raptiva should be discontinued in patients who develop PML. In postmarketing experience, serious bacterial, viral, fungal, and opportunistic infections have occurred, including pneumonia, sepsis, meningitis, and encephalitis. Some of these infections have been fatal. Postmarketing reports include cytomegaloviral infections; blastomyces, cryptococcal and tuberculous pneumonia; serious herpes infections... Neurologic Events: One case of transverse myelitis was observed during the clinical development program (2762 Raptiva-treated patients); neurologic events, including cases of Guillain-Barré Syndrome, chronic inflammatory demyelinating polyneuropathy, facial palsy, and transverse myelitis have been observed in patients receiving Raptiva in the postmarketing setting (see ADVERSE REACTIONS, Postmarketing Experience). Patients being treated with Raptiva should be instructed to report any new neurological signs or symptoms to their physician. Prescribers should exercise caution in considering the use of Raptiva in patients with significant existing or new onset nervous system adverse events. Raptiva should be discontinued in patients who develop PML.

Regranex (becaplermin) Gel 0.01 % Prescribing Information See MedWatch safety alert posted 06/06/2008.	BOXED WARNING (new) WARNINGS ...In a follow-up study, 491 (75%) of 651 subjects from two randomized, controlled trials of becaplermin gel 0.01% were followed for a median of approximately 20 months to identify malignancies diagnosed after the end of the trials... ...In a retrospective study of a medical claims database, cancer rates and overall cancer mortality were compared between 1,622 patients who used Regranex Gel and 2,809 matched comparators...	BOXED WARNING (new) WARNING: An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of Regranex Gel in a post-marketing retrospective cohort study. Regranex Gel should only be used when the benefits can be expected to outweigh the risks. Regranex Gel should be used with caution in patients with known malignancy. (See CONTRAINDICATIONS and WARNINGS). WARNINGS (See highlighted prescribing information for new text). Regranex Gel contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. (See Clinical Pharmacology). The benefits and risks of becaplermin treatment should be carefully evaluated before prescribing. Becaplermin should be used with caution in patients with a known malignancy. Malignancies distant from the site of application have occurred in becaplermin users in both a clinical study and in postmarketing use, and an increased rate of death from systemic malignancies was seen in patients who have received 3 or more tubes of Regranex Gel.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Apidra (insulin glulisine [rDNA origin] injection) Solution for Injection Prescribing Information (in new labeling format) Patient Package Inserts	CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Dosage Adjustment and Monitoring Hypoglycemia Hypokalemia Renal or Hepatic Impairment ADVERSE REACTIONS Clinical Trial Experience Table 1 Table 2 Pediatrics (new subsection) Table 3 Severe Symptomatic Hypoglycemia Table 4 (new pediatric data) Insulin Initiation and Intensification of Glucose Control Lipodystrophy Weight Gain Peripheral Edema Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII) Table 5 Allergic Reactions Local Allergy Systemic Allergy Antibody Production Postmarketing Experience (new subsection) DRUG INTERACTIONS Drugs that may increase the blood glucose-lowering effect of insulins including Apidra... Pramlintide (added) Somatostatin Analogs (added) Drugs that may reduce the blood glucose-lowering effect of Apidra... Niacin (added) USE IN SPECIFIC POPULATIONS Pediatric Use PATIENT COUNSELING INFORMATION For Patients Using Continuous Subcutaneous Insulin Pumps ...Before using a different pump with Apidra, read the pump label to make sure the pump has been evaluated with Apidra. PATIENT PACKAGE INSERTS Apidra 10 mL vial (1000 units per vial) - 100 units per mL (U-100) What is diabetes? What is Apidra? Who should not take Apidra? How should I infuse Apidra with an external insulin infusion pump? Apidra 3 mL cartridge system (300 units per cartridge system) - 100 units per mL (U-100) What is diabetes? What is Apidra? Who should not take Apidra?	CONTRAINDICATIONS Apidra is contraindicated: ...When used in patients with known hypersensitivity to Apidra or its excipients, patients may develop localized or generalized hypersensitivity reactions [See Adverse Reactions (6.1)]. WARNINGS AND PRECAUTIONS Dosage Adjustment and Monitoring: Glucose monitoring is essential for patients receiving insulin therapy... Hypoglycemia: ...The risk of hypoglycemia increases with tighter glycemic control. Patients must be educated to recognize and manage hypoglycemia... ...Intravenously administered insulin has a more rapid onset of action than subcutaneously administered insulin, requiring closer monitoring for hypoglycemia. Hypokalemia: All insulin products, including Apidra, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations)... Renal or Hepatic Impairment: Frequent glucose monitoring and insulin dose reduction may be required in patients with renal or hepatic impairment [See Clinical Pharmacology (12.4)].

Norditropin Cartridges [somatropin (rDNA origin) injection] for Subcutaneous Use Prescribing Information (in new labeling format) Patient Package Inserts	CONTRAINDICATIONS Prader-Willi Syndrome in Children WARNINGS AND PRECAUTIONS Prader-Willi Syndrome in Children ADVERSE REACTIONS Clinical Trials Experience Clinical Trials in Children Born Small for Gestational Age (SGA) with No Catch-up Growth by Age 2 - 4 Years Study 1 (Long-Term) Study 2 (Short-Term) PATIENT PACKAGE INSERT What is Norditropin NordiFlex? Norditropin is used to treat the following: children with short stature born small for gestational age (SGA) with no catch-up growth by age 2 - 4 years. How much Norditropin should you take? Children born small for gestational age (SGA) with no catch-up growth by age 2 - 4 years: Up to 0.067 mg/kg/day. INSTRUCTIONS FOR USE (see highlighted PATIENT PACKAGE INSERTS for new text).	CONTRAINDICATIONS Prader-Willi Syndrome in Children ...There have been reports of sudden death when somatropin was used in such patients [see Warnings and Precautions (5.2)]. Norditropin is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome. WARNINGS AND PRECAUTIONS Prader-Willi Syndrome in Children ...Norditropin is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Prevacid NapraPAC 500 (lansoprazole delayed-release 15 mg capsules and naproxen 500 mg tablets kit) Prescribing Information For current Medication Guide contact Takeda Pharmaceuticals at 1-877-226-4589.	CONTRAINDICATIONS WARNINGS GI Effects - Risk of Ulceration, Bleeding, and Perforation Renal Effects ...In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation... Advanced Renal Disease ...If Naprosyn therapy must be initiated, close monitoring of the patient’s renal function is advisable. Anaphylactoid Reactions Skin Reactions NSAIDs, including Naprosyn,... PRECAUTIONS General Naprosyn ...it is recommended that ophthalmic studies be carried out if any change or disturbance in vision occurs. Hepatic Effects Preexisting Asthma Drug Interactions - Naprosyn Antacids and Sucralfate Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen. Aspirin ...however, as with other NSAIDs, concomitant administration of naproxen and aspirin is not generally recommended because of the potential of increased adverse effects. Cholestyramine As with other NSAIDs, concomitant administration of cholestyramine can delay the absorption of naproxen. Methotrexate Selective Serotonin Reuptake Inhibitors (SSRIs) Drug Interactions - Prevacid Geriatric Use Naprosyn ADVERSE REACTIONS Naprosyn Initial Paragraph The following are additional adverse experiences reported in less than 1% of patients taking naproxen during clinical trials and through postmarketing reports... Cardiovascular GI Hepatobiliary Nervous System Respiratory Dermatologic Special Senses Urogenital Reproduction (female) Prevacid ...Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated the safety profile was similar... Laboratory Values (in patients who received Prevacid and laboratory results reported as adverse events) blood potassium increased blood urea increased crystal urine present eosinophilia hemoglobin decreased positive fecal occult MEDICATION GUIDE for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): NSAID Medications that Need a Prescription: Flector (added) Vicoprofen PREVACID NapraPAC Can I take other medicines with Prevacid NapraPAC? Atazanavir (added)	CONTRAINDICATIONS Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS –Preexisting Asthma). WARNINGS GI Effects - Risk of Ulceration, Bleeding, and Perforation: NSAIDs, including Naprosyn, can cause serious GI adverse events including inflammation... These serious adverse events can occur at any time, with or without warning symptoms in patients treated with NSAIDs... ...Only 1 in 5 patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. ...For high risk patients, alternate therapies that do not involve NSAIDs should be considered. Epidemiological studies, both of the case-control and cohort design, have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper GI bleeding. In two studies, concurrent use of an NSAID or aspirin potentiated the risk of bleeding (see PRECAUTIONS: Drug Interactions). Although these studies focused on upper GI bleeding, there is reason to believe that bleeding at other sites may be similarly potentiated. NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. Anaphylactoid Reactions As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Naprosyn and/or Prevacid. Naprosyn should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS, Preexisting Asthma). ...Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.

Prezista (darunavir) Tablets Prescribing Information (in new labeling format) Patient Package Insert	CONTRAINDICATIONS Table 1 (new) WARNINGS AND PRECAUTIONS General Skin Rash Sulfa Allergy Drug Interactions ADVERSE REACTIONS Initial Section Antiretroviral Treatment-Naïve Adult Subjects Study TMC114-C211 Table 2 Laboratory Abnormalities Table 3 Antiretroviral Treatment-Experienced Adult Subjects Study TMC114-C214 Table 4 Laboratory Abnormalities Table 5 Postmarketing Experience (new subsection) ...Rarely, events of hypersensitivity (including facial edema), and rhabdomyolysis (associated with co-administration with HMG-CoA reductase inhibitors and Prezista) have been reported. DRUG INTERACTIONS Potential for Prezista/rtv to Affect Other Drugs (new) Potential for Other Drugs to Affect Darunavir (new) Table 6 (updated) The following language was added after Table 6: "In addition to the drugs included in Table 6, the interaction between Prezista/rtv and the following drugs were evaluated in clinical studies and no dose adjustments are needed for either drug [see Clinical Pharmacology (12.3)]: atazanavir, efavirenz, etravirine, nevirapine, omeprazole, ranitidine, and tenofovir disoproxil fumarate." USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C (new) Prezista should be used during pregnancy only if the potential benefit justifies the potential risk. In the juvenile toxicity study where rats were directly dosed with darunavir, deaths occurred from post-natal day 5 through 11... Pediatric Use Prezista/rtv should not be used in pediatric patients below 3 years of age in view of toxicity and mortality observed in juvenile rats dosed with darunavir (from 20 mg/kg to 1000 mg/kg) up to days 23 to 26 of age [see Use in Specific Populations (8.1), Clinical Pharmacology (12.3) and Nonclinical Toxicology (13.2)]. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis and Mutagenesis PATIENT COUNSELING INFORMATION Instructions for Use Patients Taking 800 mg of Prezista Once Daily (new) PATIENT PACKAGE INSERT What is the most important information I should know about Prezista? How should I take Prezista? What are the possible side effects of Prezista?	CONTRAINDICATIONS Table 1: Drugs That Are Contraindicated With Prezista/rtv WARNINGS AND PRECAUTIONS General: Prezista must be co-administered with ritonavir and food to achieve the desired antiviral effect. Failure to administer Prezista with ritonavir and food may result in a loss of efficacy of darunavir. Skin Rash: In clinical trials (n=3063), rash (all grades, regardless of causality) occurred in 10.3% of subjects treated with Prezista [also see Adverse Reactions (6)]. Rash was mostly mild-to-moderate, often occurring within the first four weeks of treatment and resolving with continued dosing. The discontinuation rate due to rash in subjects using Prezista/rtv was 0.5%. Severe skin rash, accompanied by fever and/or elevations of transaminases in some cases, has been reported in 0.4% of subjects. Stevens-Johnson Syndrome has been rarely (<0.1%) reported. Treatment with Prezista should be discontinued if severe rash develops. Sulfa Allergy: The following sentence was added: "In clinical studies with Prezista/rtv, the incidence and severity of rash was similar in subjects with or without a history of sulfonamide allergy." Drug Interactions: See Table 1 for a listing of drugs that are contraindicated for use with Prezista/rtv due to potentially lifethreatening adverse events, significant drug-drug interactions, or loss of therapeutic effect to Prezista [see Contraindications (4)]. Please refer to Table 6 for established and other potentially significant drug-drug interactions [see Drug Interactions (7.3)].

Rozerem (ramelteon) Tablets Prescribing Information (in new labeling format) Medication Guide (new)	CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Severe Anaphylactic/Anaphylactoid Reactions Need to Evaluate for Co-morbid Dianoses ...The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated... Abnormal Thinking and Behavioral Changes CNS Effects ...Patients should be advised not to consume alcohol in combination with Rozerem as alcohol and Rozerem may have additive effects when used in conjunction. ADVERSE REACTIONS Clinical Trials Experience Adverse Reactions Resulting in Discontinuation of Treatment Rozerem Most Commonly Observed Adverse Events Table 1 DRUG INTERACTIONS Effect of Alcohol on Rozerem USE IN SPECIFIC POPULATIONS Pregnancy Nursing Mothers ...caution should be exercised when administered to a nursing woman. Geriatric Use ...A double-blind, randomized, placebo-controlled study in elderly subjects with insomnia (n=33)... Chronic Obstructive Pulmonary Disease Sleep Apnea NONCLINICAL TOXICITY Carcinogenesis Mutagenesis Impairment of Fertility PATIENT COUNSELING INFORMATION Severe Anaphylactic and Anaphylactoid Reactions Sleep-driving and other Complex Behaviors Endocrine Effects Administration Instructions ...Do not break the tablet; it should be swallowed whole. MEDICATION GUIDE (new)	CONTRAINDICATIONS Patients who develop angioedema after treatment with Rozerem should not be rechallenged with the drug. Patients should not take Rozerem in conjunction with fluvoxamine (Luvox) [see Drug Interaction (7)]. WARNINGS AND PRECAUTIONS Severe Anaphylactic/Anaphylactoid Reactions Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of Rozerem. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Rozerem should not be rechallenged with the drug. Abnormal Thinking and Behavioral Changes A variety of cognitive and behavior changes have been reported to occur in association with the use of hypnotics. In primarily depressed patients, worsening of depression (including suicidal ideation and completed suicides) has been reported in association with the use of hypnotics. Hallucinations, as well as behavioral changes such as bizarre behavior, agitation and mania have been reported with Rozerem use. Amnesia, anxiety and other neuro-psychiatric symptoms may also occur unpredictably. Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a hypnotic) and other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex), with amnesia for the event, have been reported in association with hypnotic use. The use of alcohol and other CNS depressants may increase the risk of such behaviors. These events can occur in hypnotic-naive as well as in hypnotic-experienced persons. Complex behaviors have been reported with the use of Rozerem. Discontinuation of Rozerem should be strongly considered for patients who report any complex sleep behavior.

Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate, USP) Tablets Prescribing Information	CONTRAINDICATIONS WARNINGS Carisoprodol Sedation Drug Dependence, Withdrawal, and Abuse Aspirin Serious Gastrointestinal Adverse Reactions Anaphylaxis and Anaphylactoid Reactions Codeine Phosphate Respiratory Depression Abuse and Diversion Dependence and Tolerance Gastrointestinal Obstruction Sedation Hypotension PRECAUTIONS Patients with Impaired Renal or Hepatic Function Carisoprodol Seizures Aspirin Gastrointestinal Adverse Reactions Codeine Phosphate Obscuring Medical Conditions Ultra-rapid Metabolizers of Codeine Use in Patients with Pancreatic or Biliary Duct Disease Information for Patients Carisoprodol Aspirin Codeine Phosphate Drug Interactions Carisoprodol Aspirin Codeine Phosphate Carcinogenesis, Mutagenesis, Impairment of Fertility Carisoprodol Aspirin Pregnancy: Pregnancy Category D. Carisoprodol Aspirin Labor and Delievery Carisoprodol Aspirin Codeine Phosphate Nursing Mothers Carisoprodol Aspirin Codeine Phosphate Pediatric Use Geriatric Use ADVERSE REACTIONS Initial Section Carisoprodol Aspirin	See highlighted prescribing information for extensive labeling revisions to the following labeling sections: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS. CONTRAINDICATIONS Soma Compound with Codeine is contraindicated in patients with a history of: • a serious GI complication (i.e., bleeding, perforations, obstruction) due to aspirin use • aspirin induced asthma (a symptom complex which occurs in patients who have asthma, rhinosinusitis, and nasal polyps who develop a severe, potentially fatal brochospasm shortly after taking aspirin or other NSAIDs) • hypersensitivity reaction to a carbamate such as meprobamate...

Zomig (zolmitriptan) Nasal Spray Prescribing Information (in new labeling format) Patient Package Insert	CONTRAINDICATIONS Peripheral Vascular Disease (added) WARNINGS AND PRECAUTIONS Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events Cardiac Events and Fatalities with 5-HT1 Agonists Cerebrovascular Events Other Vasospasm-Related Events, including Peripheral Vascular Ischemia and Colonic Ischemia Serotonin Syndrome ADVERSE REACTIONS Postmarketing Experience with Zomig Tablets Digestive Splenic infarction (added) General Serotonin syndrome (added) DRUG INTERACTIONS Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome USE IN SPECIFIC POPULATIONS Pegnancy Pediatric Use Hepatic Impairment NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Mutagenesis PATIENT COUNSELING INFORMATION (new) Risk of Myocardial Ischemia and/or Infarction, Other Adverse Cardiac Events, Other Vasospasm-related Event, and Cerebrovascular Events Serotonin Syndrome Device Use Pregnancy PATIENT PACKAGE INSERT Who should not take Zomig Nasal Spray? sumatriptan/naproxen (Treximet) [added] Tell your doctor if you are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)... What are the possible side effects of Zomig Nasal Spray? Some people may have a reaction called serotonin syndrome, which can be life-threatening, when they use Zomig...	CONTRAINDICATIONS Peripheral Vascular Disease: Zomig should not be given to patients with peripheral vascular disease including (but not limited to) ischemic bowel disease [see Warnings and Precautions (5.4)] WARNINGS AND PRECAUTIONS Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events - Cardiac Events and Fatalities with 5-HT1 Agonists: ...Patients who experience signs or symptoms suggestive of angina following dosing should be evaluated for the presence of CAD or a predisposition to Prinzmetal’s variant angina before receiving additional doses of medication, and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur... Cerebrovascular Events: ...As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions... Other Vasospasm-Related Events, including Peripheral Vascular Ischemia and Colonic Ischemia: Very rare reports of transient and permanent blindness and significant partial vision loss have been reported... Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome may occur with triptans, including Zomig treatment, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with Zomig and an SSRI (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) [See Drug Interactions (7.5)].

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Arixtra (fondaparinux sodium) Injection Prescribing Information	WARNINGS Hemorrhage Laboratory Testing Thrombocytopenia PRECAUTIONS General The needle guard of the prefilled syringe of Arixtra contains dry natural latex rubber that may cause allergic reactions in latex sensitive individuals. ADVERSE REACTIONS Postmarketing Experience (new subsection)	WARNINGS Hemorrhage: ...Isolated cases of elevated aPTT temporally associated with bleeding events have been reported following administration of Arixtra (with or without concomitant administration of other anticoagulants) (see ADVERSE REACTIONS: Postmarketing Experience). Laboratory Testing: ...In post-marketing experience, isolated occurrences of aPTT elevations have been reported following administration of -Arixtra (see PRECAUTIONS: Laboratory Tests and ADVERSE REACTIONS: Postmarketing Experience). Thrombocytopenia: ...Isolated occurrences of thrombocytopenia with thrombosis that manifested similar to heparin induced thrombocytopenia have been reported with use of Arixtra in postmarketing experience (see ADVERSE REACTIONS: Postmarketing Experience)...

Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets Prescribing Information (in new labeling format) Patient Package Insert	WARNINGS AND PRECAUTIONS Reproductive Risk Potential Antiretroviral Pregnancy Registry Efavirenz ADVERSE REACTIONS Postmarketing Experience Efavirenz Nervous System Disorders Cerebellar coordination and balance disturbances (added) PATIENT COUNSELING INFORMATION Reproductive Risk Potential ...Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of Atripla is recommended... PATIENT PACKAGE INSERT What should I avoid while taking Atripla? Women should not become pregnant while taking Atripla and for 12 weeks after stopping it... ...Efavirenz, a component of Atripla, may remain in your blood for a time after therapy is stopped. Therefore, you should continue to use contraceptive measures for 12 weeks after you stop taking Atripla.	WARNINGS AND PRECAUTIONS Reproductive Risk Potential: ...Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of Atripla is recommended... Antiretroviral Pregnancy Registry: Efavirenz: As of July 2007, the Antiretroviral Pregnancy Registry has received prospective reports of 373 pregnancies exposed to efavirenz-containing regimens, nearly all of which were first-trimester exposures (359 pregnancies). Birth defects occurred in 7 of 295 live births (first-trimester exposure) and 1 of 26 live births (second/third-trimester exposure). None of these prospectively reported defects were neural tube defects. However, there have been five retrospective reports of findings consistent with neural tube defects, including meningomyelocele.

Avandia (rosiglitazone maleate) Tablets Prescribing information (in new labeling format) Medication Guide	WARNINGS AND PRECAUTIONS Myocardial Ischemia MEDICATION GUIDE What is the most important information I should know about Avandia? What are the ingredients in Avandia?	WARNINGS AND PRECAUTIONS Myocardial Ischemia: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Avandia or any other oral antidiabetic drug.

Clolar (clofarabine) Injection for Intravenous Use Prescribing Information (in new labeling format)	WARNINGS AND PRECAUTIONS Hematologic Toxicity Monitor complete blood counts and platelet counts during Clolar therapy... Infections ...Monitor patients for signs and symptoms of infection and treat promptly. Hyperuricemia (Tumor Lysis) Systemic Inflammatory Response Syndrome (SIRS) and Capillary Leak Syndrome Hepatic Enzymes Hepatic and Renal Impairment Use in Pregnancy ADVERSE REACTIONS Clinical Trials Experience Initial Section Table 1 The following less common adverse reactions have been reported in 1-4% of the 115 pediatric patients with ALL or AML... Table 2 Hematologic Toxicity Infection Hepatic Renal Systemic Inflammatory Response Syndrome (SIRS) Capillary Leak Syndrome Postmarketing Experience (new subsection) USE IN SPECIFIC POPULATIONS Geriatric Use (new subsection) PATIENT COUNSELING INFORMATION (new) Hematologic Toxicity Infection Hepatic and Renal Impairment Systemic Inflammatory Response Syndrome (SIRS)/Capillary Leak Syndrome Advise male and female patients with reproductive potential to use effective contraceptive measures to prevent pregnancy...	WARNINGS AND PRECAUTIONS Hyperuricemia (Tumor Lysis): Administration of Clolar may result in a rapid reduction in peripheral leukemia cells. Evaluate and monitor patients undergoing treatment for signs and symptoms of tumor lysis syndrome. Provide intravenous infusion fluids throughout the five days of Clolar administration to reduce the effects of tumor lysis and other adverse events. Administer Allopurinol if hyperuricemia (tumor lysis) is expected. Systemic Inflammatory Response Syndrome (SIRS) and Capillary Leak Syndrome: ...Re-institute Clolar when the patient is stable, generally with a 25% dose reduction. The use of prophylactic steroids may be of benefit in preventing signs and symptoms of cytokine release. Hepatic Enzymes: Hepato-biliary enzyme elevations were frequently observed in pediatric patients during treatment with Clolar. Some patients discontinued treatment due to hepatic enzyme abnormalities. [see ADVERSE REACTIONS (6.1)]. Hepatic and Renal Impairment: ...Patients who have previously received a hematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/m2) when used in combination with etoposide (100 mg/m2) and cyclophosphamide (440 mg/m2). Severe hepatotoxic events have been reported in an ongoing Phase 1/2 combination study of clofarabine in pediatric patients with relapsed or refractory acute leukemia. Use in Pregnancy: Clolar can cause fetal harm when administered to a pregnant woman. Intravenous doses of clofarabine in rats and rabbits administered during organogenesis caused an increase in resorptions, malformations, and variations. [See Use in Specific Populations (8.1)]

Cordarone (amiodarone HCl) Tablets Prescribing Information	WARNINGS Pulmonary Toxicity First Paragraph Implantable Cardiac Devices (new)	WARNINGS Pulmonary Toxicity: The following sentence has been added to the end of the first paragraph: Post-marketing reports describe cases of pulmonary toxicity in patients treated with low doses of Cordarone; however, reports suggest that the use of lower loading and maintenance doses of Cordarone are associated with a decreased incidence of Cordarone-induced pulmonary toxicity. Implantable Cardiac Devices: In patients with implanted defibrillators or pacemakers, chronic administration of antiarrhythmic drugs may affect pacing or defibrillating thresholds. Therefore, at the inception of and during amiodarone treatment, pacing and defibrillation thresholds should be assessed.

Exjade (deferasirox) Tablets for Oral Suspension Prescribing Information (in new labeling format)	WARNINGS AND PRECAUTIONS Renal Gastrointestinal (new subsection) ADVERSE REACTIONS Clinical Trials Experience Table 1 Table 2 ...In the population of more than 5,000 patients who have been treated with Exjade during clinical trials... DRUG INTERACTIONS In healthy volunteers, the concomitant administration of Exjade and midazolam (a CYP3A4 probe substrate)... PATIENT COUNSELING INFORMATION Other Information	WARNINGS AND PRECAUTIONS Renal: ...In the clinical studies, Exjade-treated patients experienced dose-dependent increases in serum creatinine. These increases occurred at a greater frequency compared to deferoxamine-treated patients (38% vs. 14%, respectively, in Study 1 and 36% vs 22%, respectively, in Study 3). Most of the creatinine elevations remained within the normal range [see Adverse Reactions (6.1)]. There have also been reports of renal tubulopathy in patients treated with Exjade... Gastrointestinal: Gastrointestinal (GI) irritation may occur during Exjade treatment. Upper GI ulceration and hemorrhage have been reported in patients, including children and adolescents, receiving Exjade [See Adverse Reactions (6.1)]. Physicians and patients should remain alert for signs and symptoms of GI ulceration and hemorrhage during Exjade therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. Use caution when administering Exjade in combination with drugs that have ulcerogenic or hemorrhagic potential, such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, oral bisphosphonates, or anticoagulants.

Ortho Evra (norelgestromin / ethinyl estradiol transdermal system) Prescribing Information Patient Package Insert	WARNINGS Epidemiologic, case-control studies were conducted in the U.S. using electronic healthcare claims data to evaluate the risk of venous thromboembolism (VTE) among women aged 15-44 who used Ortho Evra compared to women... Table 5 (and text following Table 5) PRECAUTIONS Drug Interactions Changes in Contraceptive Effectiveness Associated With Co-Administration of Other Drugs If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception... Antibiotics Changes in Plasma Levels of Co- Administered Drugs Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine... PATIENT PACKAGE INSERT Detailed Patient Labeling General Precautions Drug Interactions Hormonal contraceptives may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures so your physician may need to adjust the dose... Other Information Special Precautions for Storage and Disposal	WARNINGS (See highlighted prescribing information for revised text). Epidemiologic, case-control studies107-111 were conducted in the U.S. using electronic healthcare claims data to evaluate the risk of venous thromboembolism (VTE) among women aged 15-44 who used Ortho Evra compared to women who used oral contraceptives containing 30-35 mcg of ethinyl estradiol (EE) and either norgestimate (NGM) or levonorgestrel (LNG). NGM is the prodrug for norelgestromin, the progestin in Ortho Evra. These studies (see Table 5) used slightly different designs and reported odds ratios ranging from 0.9 to 2.4. The interpretations of these odds ratios range from no increase in risk to an approximate doubling of risk. One study (i3 Ingenix) included patient chart review to confirm the VTE occurrence.

Pamidronate Disodium (pamidronate disodium injection) Solution for Intravenous Infusion Pamidronate Disodium (pamidronate disodium injection) Powder, Lyophilized, for Solution for Intravenous Infusion Prescribing Information	WARNINGS Deterioration in Renal Function PRECAUTIONS General Patients with a history of thyroid surgery may have relative hypoparathyroidism that may predispose to hypocalcemia with pamidronate disodium. Renal Insufficiency In clinical trials, patients with real impairment (serum creatinine >3 mg/dL) have not been studied. Limited pharmacokinetic data exist in patients with creatinine clearance <30 mL/min... Drug Interactions In multiple myeloma patients, the risk of renal dysfunction may be increased when pamidronate disodium is used in combination with thalidomide. Geriatric Use (new ) ADVERSE REACTIONS Postmarketing Experience General reactivation of Herpes simplex and Herpes zoster, influenza-like symptoms CNS confusion and visual hallucinations, sometimes in the presence of electrolyte imbalance Skin rash, pruritus Special Senses conjunctivitis Renal focal segmental glomerulosclerosis including the collapsing variant, nephrotic syndrome Laboratory Abnormalities hyperkalemia, hypernatremia, hematuria	WARNINGS Deterioration in Renal Function: Renal deterioration, progression to renal failure, and dialysis have been reported in patients after the initial or a single dose of pamidronate disodium. Focal segmental glomerulosclerosis (including the collapsing variant) with or without nephritic syndrome, which may lead to renal failure, has been reported in pamidronate disodium-treated patients, particularly in the setting of multiple myeloma and breast cancer. Some of these patients had gradual improvement in renal status after pamidronate disodium was discontinued.

Precedex (dexmedetomidine hydrochloride) Injection for Intravenous Infusion [following dilution] Prescribing Information (in new labeling format)	WARNINGS AND PRECAUTIONS Withdrawal Procedural Sedation ADVERSE REACTIONS Clinical Studies Experience Procedural Sedation Table 3 USE IN SPECIFIC POPULATIONS Geriatric Use Procedural Sedation NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility PATIENT COUNSELING INFORMATION (new)	WARNINGS AND PRECAUTIONS Withdrawal/Procedural Sedation: Withdrawal symptoms were not seen after discontinuation of short term infusions of Precedex (<6 hours).

Sutent (sunitinib malate) Capsules Prescribing Information (in new labeling format)	WARNINGS AND PRECAUTIONS Thyroid Dysfunction ADVERSE REACTIONS Postmarketing Experience	WARNINGS AND PRECAUTIONS Thyroid Dysfunction: Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of Sutent treatment. All patients should be observed closely for signs and symptoms of thyroid dysfunction on Sutent treatment. Patients with signs and/or symptoms suggestive of thyroid dysfunction should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice... ...Cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through post-marketing experience.

Treanda (bendamustine hydrochloride) for Injection, for Intravenous Infusion Prescribing Information (in new labeling format)	WARNINGS AND PRECAUTIONS Myelosuppression Skin Reactions Other Malignancies (new) ADVERSE REACTIONS Initial Section Clinical Trials Experience in NHL (new) Table 3 Table 4 Postmarketing Experience (new) USE IN SPECIFIC POPULATIONS Geriatric Use In CLL and NHL studies, there were no clinically significant differences in the adverse reaction profile between geriatric (> 65 years of age) and younger patients. Non-Hodgkin’s Lymphoma Efficacy (Overall Response Rate and Duration of Response) was similar in patients < 65 years of age and patients > 65 years. Irrespective of age, all of the 176 patients experienced at least one adverse reaction. Effect of Gender No clinically significant differences between genders were seen in the overall incidences of adverse reactions in either CLL or NHL studies. Non-Hodgkin’s Lymphoma The pharmacokinetics of bendamustine were similar in male and female patients with indolent NHL. No clinically-relevant differences between genders were seen in efficacy (ORR and DR).	WARNINGS AND PRECAUTIONS Myelosuppression: ...In the two NHL studies, 98% of patients had Grade 3-4 myelosuppression (see Table 4). Three patients (2%) died from myelosuppression-related adverse reactions; one each from neutropenic sepsis, diffuse alveolar hemorrhage with Grade 3 thrombocytopenia, and pneumonia from an opportunistic infection (CMV). Skin Reactions: ...In a study of Treanda (90 mg/m2) in combination with rituximab, one case of toxic epidermal necrolysis (TEN) occurred. TEN has been reported for rituximab (see rituximab package insert). The relationship to Treanda cannot be determined. Where skin reactions occur, they may be progressive and increase in severity with further treatment. If skin reactions are severe or progressive, Treanda should be withheld or discontinued. Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with Treanda, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia and bronchial carcinoma. The association with Treanda therapy has not been determined.

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Brand (Generic) Name	Sections Modified
Atrovent (ipratropium bromide) Nasal Spray, Metered Prescribing Information	PRECAUTIONS Carcinogenesis, Mutagenesis, Impaired of Fertility

Cefazolin for Injection USP and Dextrose Injection USP Prescribing Information	PRECAUTIONS Pediatric Use Cefazolin for Injection USP and Dextrose Injection USP is designed to deliver a 1 g dose of cefazolin. To prevent unintentional overdose, Cefazolin for Injection USP and Dextrose Injection USP should not be used in pediatric patients who require less than the full adult dose of cefazolin.

Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution) Prescribing Information	PRECAUTIONS General The following text has been added: “There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Precautions should be used when prescribing Cosopt to this group of patients.”

Diabinese (chlorpropamide) Tablets, USP Prescribing Information	PRECAUTIONS General Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Diabinese or any other anti-diabetic drug. Physician Counseling Information for Patients (new)

Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules Prescribing Information (in new labeling format)	USE IN SPECIFIC POPULATIONS Pregnancy There are no adequate and well controlled studies of Focalin in pregnant women. Dexmethylphenidate did not cause major malformations in rats or rabbits; however, it did cause delayed skeletal ossification and decreased postweaning weight gain in rats. Focalin XR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus... Labor and Delivery (new subsection) Focalin XR has not been studied in labor and delivery. Nursing Mothers ...Information from 4 published case reports on the use of racemic methylphenidate during breastfeeding suggest that at maternal doses of 35-80 mg/day, milk concentrations of methylphenidate range from undetectable to 15.4 ng/mL. Based on these limited data, the calculated infant daily dose for an exclusively breastfed infant would be about 0.4 – 2.9.9 μg/kg/day or about 0.2-0.7% of the maternal weight adjusted dose. Geriatric Use (new subsection) Focalin XR has not been studied in the geriatric population.

Fosrenol (lanthanum carbonate) Chewable Tablets Prescribing Information	PRECAUTIONS Information for Patients To aid in chewing, tablets may be crushed. (sentence added)

Glucotrol (glipizide) Tablets Prescribing Information	PRECAUTIONS General Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Glucotrol or any other anti-diabetic drug. Physician Counseling Information for Patients (new)

Glucotrol XL (glipizide) Extended Release Tablets Prescribing Information	PRECAUTIONS General Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Glucotrol XL or any other anti-diabetic drug. Physician Counseling Information for Patients (new)

Glynase PresTab (micronized glyburide tablets) Prescribing Information	PRECAUTIONS Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Glynase PresTab or any other anti-diabetic drug. Physician Counseling Information for Patients (new)

Hylenex recombinant (hyaluronidase human injection) Prescribing Information	PRECAUTIONS Pediatric Use

Kaletra (lopinavir and ritonavir) Tablet, Film Coated for Oral Use Kaletra (lopinavir and ritonavir) Solution for Oral Use Prescribing Information (in new labeling format)	DRUG INTERACTIONS Established and Other Potentially Significant Drug Interactions Table 9: Established and Other Potentially Significant Drug Interactions Non-nucleoside Reverse Transcriptase Inhibitors Efavirenz HIV CCR5 – antagonist Maraviroc Anticancer Agents Vincristine Vinblastine Anticonvulsants Phenytoin Antidepressant Bupropion Antifungals Voriconazole

Micronase (glyburide tablets, USP) Prescribing Information	PRECAUTIONS General Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Micronase or any other anti-diabetic drug. Physician Counseling Information for Patients (new)

Norvir (ritonavir) Capsules and Solution Prescribing Information	PRECAUTIONS Drug Interactions Table 6 HIV CCR5 – antagonist Maraviroc Other Agents - Anticancer Agents: Vincristine, Vinblastine Antidepressant: Bupropion

Paxil (paroxetine hydrochloride) Tablets and Oral Suspension Prescribing Information	PRECAUTIONS Drug Interactions Drug Metabolized by CYP2D6 Therefore, coadministration of Paxil with other drugs that are metabolized by this isozyme, including certain drugs effective in the treatment of major depressive disorder (e.g., nortriptyline, amitriptyline, imipramine, desipramine, and fluoxetine), phenothiazines, risperidone, tamoxifen, and Type 1C antiarrhythmics (e.g., propafenone, flecainide, and encainide), or that inhibit this enzyme (e.g., quinidine), should be approached with caution...Tamoxifen is a pro-drug requiring metabolic activation by CYP2D6. Inhibition of CYP2D6 by paroxetine may lead to reduced plasma concentrations of an active metabolite and hence reduced efficacy of tamoxifen.

Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets Prescribing Information	PRECAUTIONS Drug Interactions Drug Metabolized by CYP2D6 Therefore, coadministration of Paxil CR with other drugs that are metabolized by this isozyme, including certain drugs effective in the treatment of major depressive disorder (e.g., nortriptyline, amitriptyline, imipramine, desipramine, and fluoxetine), phenothiazines, risperidone, tamoxifen, and Type 1C antiarrhythmics (e.g., propafenone, flecainide, and encainide), or that inhibit this enzyme (e.g., quinidine), should be approached with caution...Tamoxifen is a pro-drug requiring metabolic activation by CYP2D6. Inhibition of CYP2D6 by paroxetine may lead to reduced plasma concentrations of an active metabolite and hence reduced efficacy of tamoxifen.

Prevacid (lansoprazole) Delayed-Release Capsules Prevacid (lansoprazole) For Delayed-Release Oral Suspension Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets Prescribing Information (in new labeling format)	USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic effects Pediatric Use Initial Paragraph ...Prevacid was not effective in patients with symptomatic GERD 1 month to less than 1 year of age in a multicenter... double-blind, placebo controlled study. Neonate to less than 1 year of age (new) NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility

Riomet (metformin hydrochloride oral solution) Prescribing Information	PRECAUTIONS Macrovascular Outcome There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Riomet or any other antidiabetic drug.

Skelaxin (metaxalone) Tablets Prescribing Information	PRECAUTIONS Drug Interactions The sedative effects of Skelaxin and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

Tenoretic (atenolol and chlorthalidone) Tablets Prescribing Information	PRECAUTIONS Drug Interactions Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta blockers. Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta blockers. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Theophylline in 5% Dextrose Injections USP Prescribing Information	PRECAUTIONS Pregnancy (See highlighted label for new text).

Theophylline in 5% Dextrose Injection (theophylline injection, solution) USP, in Flexible Plastic Container Prescribing Information	PRECAUTIONS Pregnancy (See highlighted label for new text).

Theophylline in Dextrose (theophylline anhydrous injection, solution) USP, in VIAFLEX Plus Container Prescribing Information	PRECAUTIONS Pregnancy (See highlighted label for new text).

Tobi (tobramycin inhalation solution, USP) Nebulizer Solution - For Inhalation Use Only Prescribing Information	PRECAUTIONS Information for Patients Disinfecting Your Nebulizer ...Every other treatment day, disinfect the nebulizer parts (except tubing) by boiling them in water for a full 10 minutes... Additional Information Tobi: 1-888-NOW-NOVA (1-888-669-6682)

Trusopt (dorzolamide hydrochloride ophthalmic solution) Prescribing Information	PRECAUTIONS General The following text has been added: “There is an increased potential for developing corneal edema in patientswith low endothelial cell counts. Precautions should be used when prescribing Trusopt to this group of patients.”

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Brand (Generic) Name	Sections Modified
Isentress (raltegravir) Tablets Prescribing Information (in new labeling format) Patient Package Insert	ADVERSE REACTIONS Postmarketing Experience Skin and Subcutaneous Tissue Disorders rash, Stevens-Johnson syndrome PATIENT PACKAGE INSERT What are the possible side effects of Isentress? Other side effects include rash and severe skin reactions (added)

Janumet (sitagliptin and metformin hydrochloride) Tablets Prescribing Information (in new labeling format)	ADVERSE REACTIONS Postmarketing Experience hepatic enzyme elevations (added)

Januvia (sitagliptin) Tablets Prescribing Information (in new labeling format)	ADVERSE REACTIONS Postmarketing Experience hepatic enzyme elevations (added)

Lasix (furosemide) Tablets Prescribing Information	ADVERSE REACTIONS Gastrointestinal System Reactions hepatic encephalopathy in patients with hepatocellular insufficiency (added) Dermatologic-Hypersensitivity Reactions bullous pemphigoid (added)

Lexapro (escitalopram oxalate) Tablets and Oral Solution Prescribing Information	ADVERSE REACTIONS Events Reported Subsequent to the Marketing of Escitalopram Cardiac Disorders cardiac failure Endocrine Disorders diabetes mellitus hyperprolactinemia Gastrointestinal Disorder rectal hemorrhage Psychiatric Disorders acute psychosis Skin and Subcutaneous Tissue Disorders urticaria Vascular Disorders deep vein thrombosis phlebitis thrombosis

Myambutol (ethambutol hydrochloride) Tablets Prescribing Information	ADVERSE REACTIONS ...Other adverse reactions reported include... erythema multiforme (added)

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Brand (Generic) Name	Sections Modified
Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets Medication Guide	MEDICATION GUIDE What if I receive a sample of Proquin XR from my healthcare provider? (new subsection)

Requip XL (ropinirole extended-release tablets) Patient Package Inserts: If you have Parkinson's Disease If you have Restless Legs Syndrome	PATIENT PACKAGE INSERT IF YOU HAVE PARKINSON'S DISEASE What are the possible side effects of Requip and Requip XL? Some patients taking Requip or Requip XL get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider. (added) PATIENT PACKAGE INSERT IF YOU HAVE RESTLESS LEGS SYNDROME (RLS) What are the possible side effects of Requip? Some patients taking Requip get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider. (added)

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