MedWatch - September 2007 Safety-Related Drug Labeling Changes

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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2007

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
Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets Prescribing Information Patient Package Insert	BOXED WARNING (new) Congestive Heart Failure CONTRAINDICATIONS WARNINGS Pioglitazone hydrochloride Cardiac Failure and Other Cardiac Effects Prospective Pioglitazone Clinical Trial In Macrovascular Events (PROactive) PRECAUTIONS General: Pioglitazone hydrochloride Edema ...Since thiazolidinediones, including pioglitazone, can cause fluid retention, which can exacerbate or lead to congestive heart failure, Actoplus Met should be used with caution in patients at risk for heart failure. Patients should be monitored for signs and symptoms of heart failure. Fractures In a randomized trial (PROactive) in patients with type 2 diabetes (mean duration of diabetes 9.5 years), an increased incidence of bone fracture was noted in female patients taking pioglitazone... ADVERSE REACTIONS Initial Paragraph Prospective Pioglitazone Clinical Trial In Macrovascular Events (PROactive) Although there was no statistically significant difference between Actos and placebo for the 3-year incidence of a first event within this composite, there was no increase in mortality or in total macrovascular events with Actos. Table 5 PATIENT PACKAGE INSERT What is the most important information I should know about Actoplus Met? What should I tell my doctor before taking Actoplus Met? What are the possible side effects of Actoplus Met? General information about Actoplus Met.	BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including pioglitazone, which is a component of Actoplus Met, cause or exacerbate congestive heart failure in some patients. After initiation of Actoplus Met, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to the current standards of care. Furthermore, discontinuation or dose reduction of Actoplus Met must be considered. Actoplus Met is not recommended in patients with symptomatic heart failure. Initiation of Actoplus Met in patients with established NYHA Class III or IV heart failure is contraindicated. CONTRAINDICATIONS Initiation of Actoplus Met in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated... WARNINGS: Pioglitazone hydrochloride/Cardiac Failure and Other Cardiac Effects Pioglitazone, like other thiazolidinediones, can cause fluid retention when used alone or in combination with other antihyperglycemic agents, including insulin. Fluid retention may lead to or exacerbate heart failure... Furthermore, discontinuation or dose reduction of pioglitazone must be considered. Patients with NYHA Class III and IV cardiac status were not studied during pre-approval clinical trials and pioglitazone is not recommended in these patients. WARNINGS: Prospective Pioglitazone Clinical Trial In Macrovascular Events (PROactive) In PROactive, 5238 patients with type 2 diabetes and a prior history of macrovascular disease were treated with Actos (n=2605), force-titrated up to 45 mg once daily, or placebo (n=2633). The percentage of patients who had an event of serious heart failure was higher for patients treated with Actos (5.7%, n=149) than for patients treated with placebo (4.1%, n=108). The incidence of death subsequent to a report of serious heart failure was 1.5% (n=40) in patients treated with Actos and 1.4% (n=37) in placebo-treated patients. In patients treated with an insulin-containing regimen at baseline, the incidence of serious heart failure was 6.3% (n=54/864) with Actos and 5.2% (n=47/896) with placebo. For those patients treated with a sulfonylurea-containing regimen at baseline, the incidence of serious heart failure was 5.8% (n=94/1624) with Actos and 4.4% (n=71/1626) with placebo.

Campath (alemtuzumab) Injection for Intravenous Use Prescribing Information (in new labeling format)	BOXED WARNING Cytopenias Infusion Reactions Infections WARNINGS & PRECAUTIONS Cytopenias Infusion Reactions Immunosuppression/Infections Laboratory Monitoring Immunization ADVERSE REACTIONS Initial Section Clinical Trials Experience Initial Section Lymphopenia Neutropenia Anemia Thrombocytopenia Infusion Reactions Infections Cardiac Previously Untreated Patients Table 1 Previously Treated Patients Immunogenicity Postmarketing Experiences Fatal Infusion Reactions Infections Epstein-Barr Virus (EBV) Progressive Multifocal Leukoencephalopathy (PML) Immune Disorders Aplastic Anemia Chronic Inflammatory Demyelinating Polyradiculoneuropathy Cardiovascular Cardiomyopathy Decreased Ejection Fraction... USE IN SPECIFIC POPULATIONS Nursing Mothers Geriatric Use PATIENT COUNSELING INFORMATION Cytopenias Infusion Reactions Infections Advise patients that irradiation of blood prodcuts is required... Advise patients that they should not be immunized with live viral vaccines... Advise male and female patients with reproductive potential to use effective contraceptive methods...	BOXED WARNING Cytopenias Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia. Infusion Reactions Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days. Infections Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections. WARNINGS & PRECAUTIONS See highlighted prescribing information for revised text.

CellCept (mycophenolate mofetil capsules) (mycophenolate mofetil tablets) CellCept Oral Suspension (mycophenolate mofetil for oral suspension) CellCept Intravenous (mycophenolate mofetil hydrochloride for injection) Prescribing Information	BOXED WARNING WARNINGS Initial Section Pregnancy: Teratogenic Effects: Pregnancy Category D Pregnancy Exposure Prevention PRECAUTIONS Information for Patients ADVERSE REACTIONS Postmarketing Experience Congenital Disorders ...including ear malformations have been reported in offspring of patients exposed to mycophenolate mofetil during pregnancy.	BOXED WARNING Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma... ...Female users of childbearing potential must use contraception. Use of CellCept during pregnancy is associated with increased risk of pregnancy loss and congenital malformations. WARNINGS: Initial Section ...Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections, fatal infections, and sepsis. In patients receiving CellCept (2 g or 3 g) in controlled studies for prevention of renal, cardiac or hepatic rejection, fatal infection/sepsis occurred in approximately 2% of renal and cardiac patients and in 5% of hepatic patients... WARNINGS: Pregnancy: Teratogenic Effects: Pregnancy Category D & WARNINGS: Pregnancy Exposure Prevention See highlighted prescribing information for revised text.

Diovan HCT (valsartan and hydrochlorothiazide, USP) Tablets Prescribing Information	BOXED WARNING Use in Pregnancy WARNINGS Fetal/Neonatal Morbidity and Mortality PRECAUTIONS Information for Patients Pregnancy Female patients of childbearing age should be told about the consequences of exposure to drugs that act on the renin-angiotensin system. Discuss other treatment options with female patients planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.	BOXED WARNING: Use in Pregnancy When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus... WARNINGS: Fetal/Neonatal Morbidity and Mortality ...In addition, first trimester use of ACE inhibitors, a specific class of drugs acting on the renin-angiotensin system, has been associated with a potential risk of birth defects in retrospective data. Healthcare professionals that prescribe drugs acting directly on the renin-angiotensin system should counsel women of childbearing potential about the potential risks of these agents during pregnancy.

Duetact (pioglitazone HCl plus glimepiride) Prescribing Information Patient Package Insert See MedWatch Safety Alert posted on 8/14/2007 for additional information on recent FDA Press Release and Information for Healthcare Professionals.	BOXED WARNING (new) Congestive Heart Failure CONTRAINDICATIONS WARNINGS Pioglitazone hydrochloride Cardiac Failure and Other Cardiac Effects Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive) PRECAUTIONS General: Pioglitazone hydrochloride Edema ...Since thiazolidinediones, including pioglitazone, can cause fluid retention, which can exacerbate or lead to congestive heart failure, Duetact should be used with caution in patients at risk for heart failure. Patients should be monitored for signs and symptoms of heart failure. Fractures In a randomized trial (PROactive) in patients with type 2 diabetes (mean duration of diabetes 9.5 years), an increased incidence of bone fracture was noted in female patients taking pioglitazone... ADVERSE REACTIONS Pioglitazone hydrochloride Initial Section Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive) Table 5 PATIENT PACKAGE INSERT What is the most important information I should know about Duetact? What should I tell my doctor before taking Duetact? What are the possible serious side effects of Duetact?	BOXED WARNING: Congestive Heart Failure Thiazolidinediones, including pioglitazone, which is a component of Duetact, cause or exacerbate congestive heart failure in some patients. After initiation of Duetact, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to the current standards of care. Furthermore, discontinuation of Duetact must be considered. Duetact is not recommended in patients with symptomatic heart failure. Initiation of Duetact in patients with established NYHA Class III or IV heart failure is contraindicated. CONTRAINDICATIONS Initiation of Duetact in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated... WARNINGS: Pioglitazone hydrochloride/Cardiac Failure and Other Cardiac Effects ...If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of pioglitazone must be considered... WARNINGS: Prospective Pioglitazone Clinical Trial In Macrovascular Events (PROactive) In PROactive, 5238 patients with type 2 diabetes and a prior history of macrovascular disease were treated with Actos (n=2605), force-titrated up to 45 mg once daily, or placebo (n=2633). The percentage of patients who had an event of serious heart failure was higher for patients treated with Actos (5.7%, n=149) than for patients treated with placebo (4.1%, n=108). The incidence of death subsequent to a report of serious heart failure was 1.5% (n=40) in patients treated with Actos and 1.4% (n=37) in placebo-treated patients. In patients treated with an insulin-containing regimen at baseline, the incidence of serious heart failure was 6.3% (n=54/864) with Actos and 5.2% (n=47/896) with placebo. For those patients treated with a sulfonylurea-containing regimen at baseline, the incidence of serious heart failure was 5.8% (n=94/1624) with Actos and 4.4% (n=71/1626) with placebo.

Evista (raloxifene hydrochloride) Tablets for Oral Use Prescribing Information (in new labeling format) Medication Guide	BOXED WARNING (new) Increased Risk of Venous Thromboembolism and Death from Stroke WARNINGS AND PRECAUTIONS Venous Thromboembolism ADVERSE REACTIONS Clinical Trials Experience Placebo-Controlled Trial of Postmenopausal Women at Increased Risk for Major Coronary Events (RUTH) Tamoxifen-Controlled Trial of Postmenopausal Women at Increased Risk for Invasive Breast Cancer (STAR) PATIENT COUNSELING INFORMATION Reduction in Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis or at High Risk of Invasive Breast Cancer MEDICATION GUIDE (revised)	BOXED WARNING: Increased Risk of Venous Thromboembolism and Death from Sroke Increased risk of deep vein thrombosis and pulmonary embolism have been reported with Evista. Women with active or past history of venous thromboembolism should not take Evista. Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke. WARNINGS AND PRECAUTIONS: Venous Thromboembolism ...A less serious event, superficial thrombophlebitis, also has been reported more frequently with Evista than with placebo...

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
MDP Multidose Kit for the Preparation of Technetium Tc99m Medronate Injection DIAGNOSTIC - FOR INTRAVENOUS USE Prescribing Information	CONTRAINDICATIONS WARNINGS ADVERSE REACTIONS Postmarketing Experience	CONTRAINDICATIONS Hypersensitivity to technetium Tc99m medronate or to any of the excipients. WARNINGS Anaphylactic/anaphylactoid reactions that may be life-threatening have occurred with the use of technetium Tc99m medronate. Manifestations include: shock, hypotension, loss of consciousness, dyspnea, cyanosis, wheezing, generalized rash, and pruritus. Advanced life support equipment and trained personnel should be readily available. This class of compound is known to complex cations such as calcium. Particular caution should be used with patients who have, or who may be predisposed to, hypocalcemia (i.e., alkalosis). The clinical significance of this information is unknown as no cases of hypocalcemia have been reported. Reports indicate impairment of brain scans using sodium pertechnetate Tc99m injection which have been preceded by a bone scan using an agent containing stannous ions. This impairment may result in false-positive or false-negative brain scans. It is recommended that brain scans precede bone imaging procedures. Alternately, a brain-imaging agent such as technetium Tc99m pentetate injection may be employed.

MDP Multidose Utilipak Kit for the Preparation of Technetium Tc99m Medronate Injection DIAGNOSTIC - FOR INTRAVENOUS USE Prescribing Information	CONTRAINDICATIONS WARNINGS ADVERSE REACTIONS Postmarketing Experience	CONTRAINDICATIONS Hypersensitivity to technetium Tc99m medronate or to any of the excipients. WARNINGS Anaphylactic/anaphylactoid reactions that may be life-threatening have occurred with the use of technetium Tc99m medronate. Manifestations include: shock, hypotension, loss of consciousness, dyspnea, cyanosis, wheezing, generalized rash, and pruritus. Advanced life support equipment and trained personnel should be readily available. This class of compound is known to complex cations such as calcium. Particular caution should be used with patients who have, or who may be predisposed to, hypocalcemia (i.e., alkalosis). The clinical significance of this information is unknown as no cases of hypocalcemia have been reported. Reports indicate impairment of brain scans using sodium pertechnetate Tc99m injection which have been preceded by a bone scan using an agent containing stannous ions. This impairment may result in false-positive or false-negative brain scans. It is recommended that brain scans precede bone imaging procedures. Alternately, a brain-imaging agent such as technetium Tc99m pentetate injection may be employed.

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Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Avastin (bevacizumab) for Intravenous Use Prescribing Information	WARNINGS Non-Gastrointestinal Fistula Formation ADVERSE REACTIONS The most serious adverse reactions in patients receiving Avastin were: ...Non-Gastrointestinal Fistula Formation (see WARNINGS) Non-Gastrointestinal Fistula Formation	WARNINGS: Non-Gastrointestinal Fistula Formation Non-gastrointestinal fistula formation has been reported in patients treated with Avastin in controlled clinical studies (with an incidence of < 0.3%) and in post-marketing experience, in some cases with fatal outcome. Fistula formation involving the following areas of the body other than the gastrointestinal tract have been reported: tracheo-esophageal, bronchopleural, biliary, vagina and bladder. Events were reported throughout treatment with Avastin, with most events occurring within the first 6 months. Permanently discontinue Avastin in patients with fistula formation involving an internal organ.

Butisol Sodium (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP) Tablets and Oral Solution Prescribing Information	WARNINGS Initial Section Severe Anaphylactic and 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 sedative-hypnotics. 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 sedative-hypnotics should not be rechallenged with the drug. PRECAUTIONS Information for Patients “Sleep Driving” and Other Complex Behaviors There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since “sleep driving” can be dangerous. This behavior is more likely to occur when sedative-hypnotics are taken with alcohol or other central nervous depressants...	WARNINGS: Initial Section ... 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. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequences of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative-hypnotic drugs. Because some of the important adverse effects of sedative-hypnotics appear to be dose related, it is important to use the smallest possible effective dose, especially in the elderly. Complex behaviors such as “sleep driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with sedative-hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with sedative-hypnotics appears to increase the risk of such behaviors, as does the use of sedative-hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of sedative-hypnotics should be strongly considered for patients who report a “sleep driving” episode”. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events.

Cefazolin for Injection, USP and Dextrose Injection, USP Prescribing Information	WARNINGS PRECAUTIONS Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.	WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefazolin for Injection USP and Dextrose Injection USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

CefOTAXime for Injection, USP and Dextrose Injection Prescribing Information	WARNINGS PRECAUTIONS Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.	WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefotaxime for Injection USP and Dextrose Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

CefTRIaxONE for lnjection and Dextrose lnjection Prescribing Information	WARNINGS PRECAUTIONS Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.	WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ceftriaxone for lnjection and Dextrose Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

CefUROXime for Injection, USP and Dextrose Injection, USP Prescribing Information	WARNINGS PRECAUTIONS Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.	Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefuroxime for Injection USP and Dextrose Injection USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Cefzil (cefprozil) Tablets Cefzil (cefprozil) for Oral Suspension Prescribing Information	WARNINGS PRECAUTIONS Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.	Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefzil, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Gleevec (imatinib mesylate) Tablets for Oral Use Prescribing Information (in new labeling format)	WARNINGS & PRECAUTIONS Pregnancy Fluid Rentention and Edema Hematologic Toxicity Severe Congestive Heart Failure and Left Ventricular Dysfunction Hemorrhage Hypereosinophilic Cardiac Toxicity ADVERSE REACTIONS Chronic Myeloid Leukemia Table 2 Hepatotoxicity Adverse Reactions in Pediatric Population Acute Lymphoblastic Leukemia Myelodyplastic/Myeloproliferative Diseases Table 6 Aggressive Systemic Mastocytosis Hypereosinophilic Syndrome and Chronic Eosinophilic Leukemia Dermatofibrosarcoma Protuberans Table 7 Table 8 Postmarketing Experience DRUG INTERACTIONS Agents Inducing CYP3A Metabolism Interactions with Drugs Metabolized by CYP3A4 Interaction with Acetaminophen USE IN SPECIFIC POPULATIONS Nursing Mothers Pediatric Use Hepatic Impairment Table 11 Renal Impairment NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility PATIENT COUNSELING INFORMATION Dosing and Administration Pregnancy and Breast Feeding Adverse Reactions Drug Interactions	WARNINGS & PRECAUTIONS Pregnancy Women of childbearing potential should be advised to avoid becoming pregnant while taking Gleevec. Sexually active female patients taking Gleevec should use adequate contraception. Gleevec can cause fetal harm when administered to a pregnant woman... There are no adequate and well-controlled studies with Gleevec in pregnant woman. Women should be advised not to become pregnant when taking Gleevec... Fluid Retention and Edema See highlighted prescribing information for revised text. Hematologic Toxicity ...In pediatric CML patients the most frequent toxicities observed were grade 3 or 4 cytopenias including neutropenia, thrombocytopenia and anemia. These generally occur within the first several months of therapy. Severe Congestive Heart Failure and Left Ventricular Dyfunction Severe congestive heart failure and left ventricular dysfunction have occasionally been reported in patients taking Gleevec. Most of the patients with reported cardiac reactions have had other co-morbidities and risk factors, including advanced age and previous medical history of cardiac disease... ...Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated. Hemorrhage In the newly diagnosed CML trial, 1.8% of patients had Grade 3/4 hemorrhage... Hypereosinophilic Cardiac Toxicity In patients with hypereosinophilic syndrome and cardiac involvement, cases of cardiogenic shock/left ventricular dysfunction have been associated with the initiation of imatinib therapy. The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures and temporarily withholding imatinib. Myelodysplastic/myeloproliferative disease and systemic mastocytosis may be associated with high eosinophil levels. Performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD or ASM associated with high eosinophil levels. If either is abnormal, the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.

Haldol brand of haloperidol injection (for Immediate Release) Prescribing Information	WARNINGS Cardiovascular Effects	WARNINGS: Cardiovascular Effects Cases of sudden death, QT-prolongation, and Torsades de Pointes have been reported in patients receiving Haldol. Higher than recommended doses of any formulation and intravenous administration of Haldol appear to be associated with a higher risk of QT-prolongation and Torsades de Pointes. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome). HALDOL INJECTION IS NOT APPROVED FOR INTRAVENOUS ADMINISTRATION. If HALDOL is administered intravenously, the ECG should be monitored for QT prolongation and arrhythmias.

Haldol Decanoate 50 (haloperidol) Haldol Decanoate 100 (haloperidol) For IM Injection Only Prescribing Information	WARNINGS Cardiovascular Effects	WARNINGS: Cardiovascular Effects Cases of sudden death, QT-prolongation, and Torsades de Pointes have been reported in patients receiving haloperidol. Higher than recommended doses of any formulation and intravenous administration of haloperidol appear to be associated with a higher risk of QT-prolongation and Torsades de Pointes. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome). HALDOL DECANOATE MUST NOT BE ADMINISTERED INTRAVENOUSLY.

HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed release tablets) Prescribing Information (in new labeling format) Patient Package Insert	WARNINGS & PRECAUTIONS Neurologic Gastrointestinal Allergic Reaction ADVERSE REACTIONS Clinical Studies Experience Table 1 Table 2 Postmarketing Experience Allergic Reaction Urticaria Rhinorrhea Dermatitis Anaphylactic Reactions Gastrointestinal ...Upper GI Bleeding from a Mallory-Weiss Tear Esophageal Perforation Asystole, Acute Pulmonary Edema after vomiting and aspirating the PEG-based solution... Neurologic Generalized Tonic-Clonic Seizures... Dizziness Syncope USE IN SPECIFIC POPULATIONS Geriatric Use PATIENT COUNSELING INFORMATION PATIENT PACKAGE INSERT (updated)	WARNINGS & PRECAUTIONS Neurologic There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatemia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients. Gastrointestinal Use with caution in patient with severe ulcerative colitis, ileus or gastric retention. Observe patients with impaired gag reflex and patients prone to regurgitation or aspiration during administration of HalfLytely solution. If GI obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration. There have been reports of ischemic colitis in patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit. If patients develop severe abdominal pain or rectal bleeding, patients should be evaluated as soon as possible. Allergic Reaction Hives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction.

Keppra (levetiracetam) Injection for Intravenous Use Prescribing Information (in new labeling format)	WARNINGS & PRECAUTIONS Neuropsychiatric Adverse Reactions Myoclonic Seizures Hematologic Abnormalities Juvenile Myclonic Epilepsy ADVERSE REACTIONS Clinical Studies Experience Myoclonic Seizures Table 4 Discontinuation Or Dose Reduction in Well-Controlled Clinical Studies Partial Onset Seizures Table 5 Myoclonic Seizures Table 6 Postmarketing Experience Hepatic Failure PATIENT COUNSELING INFORMATION Patients should be advised that Keppra may cause changes in behavior (e.g. aggression, agitation, anger, anxiety, apathy, depression, hostility, and irritability) and in rare cases patients may experience psychotic symptoms and/or suicidal ideation.	WARNINGS & PRECAUTIONS:Neuropsychiatric Adverse Reactions/Myoclonic Seizures ... In some patients experiencing myoclonic seizures, Keppra causes somnolence and behavioral abnormalities. It is expected that the events seen in partial seizure patients would occur in patients with Juvenile Myclonic Epilepsy (JME). In the double-blind, controlled trial in patients with juvenile myoclonic epilepsy experiencing myoclonic seizures, 11.7% of Keppra-treated patients experienced somnolence compared to 1.7% of placebo patients. No patient discontinued treatment as a result of somnolence. In 1.7% of Keppra-treated patients and in 0% of placebo patients the dose was reduced as a result of somnolence. Non-psychotic behavioral disorders (reported as aggression and irritability) occurred in 5% of the Keppra-treated patients compared to 0% of placebo patients. Non-psychotic mood disorders (reported as depressed mood, depression, and mood swings) occurred in 6.7% of Keppra-treated patients compared to 3.3% of placebo patients. A total of 5.0% of Keppra-treated patients had a reduction in dose or discontinued treatment due to behavioral or psychiatric events (reported as anxiety, depressed mood, depression, irritability, and nervousness), compared to 1.7% of placebo patients. Hematologic Abnormalities: Juvenile Myoclonic Epilepsy Although there were no obvious hematologic abnormalities observed in patients with JME, the limited number of patients makes any conclusion tentative. The data from the partial seizure patients should be considered to be relevant for JME patients.

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) Patient Package Insert	WARNINGS & PRECAUTIONS Prolongation of the QT Interval Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals ADVERSE REACTIONS Clinical Trial Experience USE IN SPECIFIC POPULATIONS Pediatric Use PATIENT COUNSELING INFORMATION Administration with Food, Fluids, and Concomitant Medications Drug Interactions with Insulin, Oral Hypoglycemic Agents, and Warfarin PATIENT PACKAGE INSERT What are the possible side effects of Levaquin?	WARNINGS & PRECAUTIONS Prolongation of the QT Interval ...Elderly patients may be more susceptible to drug-associated effects on the QT interval. Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals Levaquin is not indicated for pediatric patients (less than 18 years of age). An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) compared to controls has been observed in pediatric patients receiving Levaquin.

Lipitor (atorvastatin calcium) Tablets Prescribing Information	WARNINGS Skeletal Muscle PRECAUTIONS Drug Interactions The risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin or cytochrome P450 3A4 inhibitors... Inhibitors of Cytochrome P450 3A4 Clarithromycin Erythromycin Combination of Protease Inhibitors Itraconazole Diltiazem Hydrochloride Cimetidine Grapefruit Juice Cyclosporine Inducers of Cytochrome P450 3A4 Antacid Antipyrine Colestipol Digoxin Oral Contraceptives Warfarin Amlodipine	WARNINGS: Skeletal Muscle ...Physicians considering combined therapy with atorvastatin and fibric acid derivatives, erythromycin, clarithromycin, a combination of ritonavir plus saquinavir or lopinavir plus ritonavir, immunosuppressive drugs, azole antifungals, or lipid-modifying doses of niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Lower starting and maintenance doses of atorvastatin should be considered when taken concomitantly with the aforementioned drugs...

Neupogen (filgrastim) Prescribing Information Patient Package Insert	WARNINGS Alveolar Hemorrhage and Hemoptysis ADVERSE REACTIONS Postmarketing Experience Sweet's Syndrome (acute febrile neutrophilic dermatosis) PATIENT PACKAGE INSERT (updated) What is Neupogen used for? How does Neupogen work? What important information do I need to know about taking Neupogen? What are possible serious side effects of Neuopgen? What are the most common side effects of Neupogen?	WARNINGS: Alveolar Hemorrhage and Hemoptysis Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization has been reported in healthy donors undergoing peripheral blood progenitor cell (PBPC) mobilization. Hemoptysis resolved with discontinuation of Neupogen. The use of Neupogen for PBPC mobilization in healthy donors is not an approved indication.

Norditropin Cartridges [somatropin (rDNA origin) injection], for Subcutaneous Use Prescribing Information (in new labeling format) Patient Package Insert: Norditropin NordiFlex Somatropin (rDNA origin) Injection - Prefilled Pen	WARNINGS & PRECAUTIONS Otitis Media and Cardiovascular Disorders in Turner Syndrome ADVERSE REACTIONS Clinical Trials Experience Clinical Trials in Children with Turner Syndrome PATIENT PACKAGE INSERT What is Norditropin NordiFlex? How much Norditropin should I take?	WARNINGS & PRECAUTIONS: Otitis Media and Cardiovascular Disorders in Turner Syndrome Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions.

Soma (carisoprodol) Tablets for Oral Use Prescribing Information (in new labeling format)	WARNINGS & PRECAUTIONS Sedation Drug Dependence, Withdrawal, and Abuse Seizures ADVERSE REACTIONS Clinical Studies Experience Table 1 Drug Interactions CNS Depressants CYP2C19 Inhibitors and Inducers USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category C Initial Paragraph Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use Renal Impairment Hepatic Impairment Patients with Reduced CYP2C19 Activity NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility PATIENT COUNSELING INFORMATION Sedation Avoidance of Alcohol and Other CNS Depressants Soma Should Only Be Used for Short-Term Treatment	WARNINGS & PRECAUTIONS Sedation Soma may have sedative properties (in the low back pain trials, 13% to 17% of patients who received Soma experienced sedation compared to 6% of patients who received placebo)... Drug Dependence, Withdrawal, and Abuse In the postmarketing experience with Soma, cases of dependence, withdrawal, and abuse have been reported with prolonged use. Most cases of dependence, withdrawal, and abuse occurred in patients who have had a history of addiction or who used Soma in combination with other drugs with abuse potential. Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce the chance of Soma dependence, withdrawal, or abuse, Soma should be used with caution in addiction-prone patients and in patients taking other CNS depressants including alcohol, and Soma should be not be used more than two to three weeks for the relief of acute musculoskeletal discomfort. One of the metabolites of Soma, meprobamate (a controlled substance), may cause dependence. Seizures There have been postmarketing reports of seizures in patients who received Soma. Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol).

Taxotere (docetaxel) Injection Concentrate, Intravenous Infusion Prescribing Information (in new labeling format) Patient Package Insert	WARNINGS & PRECAUTIONS Hypersensitivity Reactions Acute Myeloid Leukemia ADVERSE REACTIONS Clinical Trial Experience Combination Therapy with Taxotere in the Adjuvant Treatment of Breast Cancer Cardiovascular Events Head and Neck Cancer Combination Therapy with Taxotere in Head and Neck Cancer Table 12 Postmarketing Experiences Hematologic ...Disseminated Intravascular Coagulation (DIC)... USE IN SPECIFIC POPULATIONS Nursing Mothers Geriatric Use Hepatic Impairment NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility PATIENT PACKAGE INSERT What are the possible side effects of Taxotere?	WARNINGS & PRECAUTIONS Hypersensitivity Reactions ...Severe hypersensitivity reactions require immediate discontinuation of the Taxotere infusion and aggressive therapy... ...Hypersensitivity reactions may occur within a few minutes following initiation of a Taxotere infusion. If minor reactions such as flushing or localized skin reactions occur, interruption of therapy is not required. All patients should be premedicated with an oral corticosteroid prior to the initiation of the infusion of Taxotere. Acute Myeloid Leukemia ...In the Taxotere, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukemia requires hematological follow-up.

Vancomycin Hydrochloride (vancomycin hydrochloride) Injection, Solution for Intravenous Use Only Prescribing Information	WARNINGS PRECAUTIONS Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.	WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Vancomycin Injection, USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

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Brand (Generic) Name	Sections Modified
Actos (pioglitazone hydrochloride) Tablets Prescribing Information	PRECAUTIONS Fractures In a randomized trial (PROactive) in patients with type 2 diabetes (mean duration of diabetes 9.5 years), an increased incidence of bone fracture was noted in female patients taking pioglitazone...

Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets Prescribing Information Patient Package Insert	PRECAUTIONS Rosiglitazone maleate Fractures In a 4- to 6-year comparative study (ADOPT) of glycemic control with monotherapy in drug-naïve patients recently diagnosed with type 2 diabetes mellitus, an increased incidence of bone fracture was noted in female patients taking rosiglitazone. PATIENT PACKAGE INSERT What are the possible side effects of Avandamet?

Avandaryl (rosiglitazone maleate and glimepiride) Tablets Prescribing Information Patient Package Insert	PRECAUTIONS Fractures In a 4- to 6-year comparative study (ADOPT) of glycemic control with monotherapy in drug-naïve patients recently diagnosed with type 2 diabetes mellitus, an increased incidence of bone fracture was noted in female patients taking rosiglitazone... ...No increase in fracture rates was observed in men treated with rosiglitazone... Pregnancy: Pregnancy Category C Rosiglitazone Rosiglitazone has been reported to cross the human placenta and be detectable in fetal tissue. The clinical significance of these findings is unknown... ADVERSE REACTIONS Rosiglitazone In postmarketing experience with rosiglitazone, rash, pruritus, urticaria, angioedema and anaphylactic reaction have been reported rarely... PATIENT PACKAGE INSERT What are the possible side effects of Avandaryl?

Avandia (rosiglitazone maleate) Tablets Prescribing Information Patient Package Insert	PRECAUTIONS General Fractures In a 4- to 6-year comparative study (ADOPT) of glycemic control with monotherapy in drug-naïve patients recently diagnosed with type 2 diabetes mellitus, an increased incidence of bone fracture was noted in female patients taking Avandia... PATIENT PACKAGE INSERT What are the possible side effects of Avandia?

Caduet (amlodipine besylate/atorvastatin calcium) Tablets Prescribing Information	PRECAUTIONS Geriatric Use In studies with Atorvastatin Use in Patients with Recent Stroke or TIA ADVERSE REACTIONS Clinical Adverse Experiences Treating to New Targets Study (TNT) Postintroduction Reports with Atorvastatin Fatigue Tendon Rupture

Dovonex (calcipotriene cream) Cream, 0.005% Prescribing Information	PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility

Dovonex (calcipotriene ointment), 0.005% Prescribing Information	PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility

Dovonex (calcipotriene solution) Scalp Solution, 0.005% Prescribing Information	PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility

Effexor (venlafaxine hydrochloride) Tablets Prescribing Information	PRECAUTIONS General Discontinuation of Treatment Impaired Balance Hyponatremia Geriatric Use ...SSRIs and SNRIs, including Effexor, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event. ADVERSE REACTIONS Postmarketing Reports Impaired Coordination and Balance

Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules Prescribing Information	PRECAUTIONS General Discontinuation of Treatment Impaired Balance Hyponatremia Geriatric Use ...SSRIs and SNRIs, including Effexor XR, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event. ADVERSE REACTIONS Postmarketing Reports Impaired Coordination and Balance

Epivir-HBV (lamivudine) Tablets and Oral Solution Prescribing Information Patient Package Insert	PRECAUTIONS Emergence of Resistance-Associated HBV Mutations ...In clinical practice, monitoring of ALT and HBV DNA levels during lamivudine treatment may aid in treatment decisions if emergence of viral mutants is suspected. Information for Patients "Epzicom Tablets" (added to list as other drugs containing lamivudine) PATIENT PACKAGE INSERT What is Epivir-HBV? Why should I consider HIV testing before starting treatment with Epivir-HBV? If I am HIV-positive, can I take Epivir-HBV? Who should not take Epivir-HBV? How should I take Epivir-HBV?

Inderal (propranolol hydrochloride) Tablets Prescribing Information	PRECAUTIONS Drug Interactions Cardiovascular Drugs Digitalis Glycosides Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Kaletra (lopinavir/ritonavir) Capsules and Oral Solution Prescribing Information	PRECAUTIONS Drug Interactions Table 11 HMG-CoA Reductase Inhibitors Rosuvastatin Use lowest possible dose of atorvastatin or rosuvastatin with careful monitoring, or consider other HMG-CoA reductase inhibitors such as pravastatin or fluvastatin in combination with Kaletra.

Kaletra (lopinavir/ritonavir) Tablets and Oral Solution Prescribing Information	PRECAUTIONS Drug Interactions Table 11 HMG-CoA Reductase Inhibitors Rosuvastatin Use lowest possible dose of atorvastatin or rosuvastatin with careful monitoring, or consider other HMG-CoA reductase inhibitors such as pravastatin or fluvastatin in combination with Kaletra.

Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets Prescribing Information Patient Package Insert	PRECAUTIONS General Photosensitivity/Phototoxicity Reactions Information for Patients ...photosensitivity/phototoxicity has been reported in patients receiving quinolone antibiotics... ADVERSE REACTIONS Skin/Subcutaneous Tissue Disorders Photosensitivity/Phototoxicity Reaction Reported Postmarketing Adverse Events with Other Formulations of Ciprofloxacin Photosensitivity/Phototoxicity Reaction PATIENT PACKAGE INSERT What are possible side effects of Proquin XR?

Voltaren Ophthalmic (diclofenac sodium ophthalmic solution) 0.1% Prescribing Information	PRECAUTIONS General Carcinogenesis, Mutagenesis, Impairment of Fertility Geriatric Use ADVERSE REACTIONS Clinical Practice Ocular Corneal Opacity

Zebeta (bisoprolol fumarate) Tablets Prescribing Information	PRECAUTIONS Drug Interactions Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets Prescribing Information	PRECAUTIONS Drug Interactions Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

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Brand (Generic) Name	Sections Modified
Abilify (aripiprazole) Tablets and Oral Solution Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets Abilify (aripiprazole) Injection for Intramuscular Use Only Prescribing Information	ADVERSE REACTIONS Other Events Observed During the Postmarketing Evaluation of Aripiprazole Oropharyngeal Spasm Grand Mal Seizure Jaundice

Anzemet (dolasetron mesylate) Injection Contact Sanofi-aventis at 1-800-207-8049 for prescribing information.	ADVERSE REACTIONS Postmarketing Experience There are rare reports of wide complex tachycardia or ventricular tachycardia and of ventricular fibrillation cardiac arrest following intravenous administration.

Anzemet (dolasetron mesylate) Tablets Contact Sanofi-aventis at 1-800-207-8049 for prescribing information.	ADVERSE REACTIONS Postmarketing Experience There are rare reports of wide complex tachycardia or ventricular tachycardia and of ventricular fibrillation cardiac arrest following intravenous administration.

Benicar (olmesartan medoxomil) Prescribing Information	ADVERSE REACTIONS Postmarketing Experience Metabolic and Nutritional Disorders Hyperkalemia

BuSpar (buspirone HCl, USP) Tablets Prescribing Information	ADVERSE REACTIONS Postmarketing Experience Dystonic Reactions (including dystonia) Parkinsonism Akathisia Restless Leg Syndrome Restlessness

Keppra (levetiracetam) Tablets and Oral Solution Prescribing Information	ADVERSE REACTIONS Postmarketing Experience Hepatic Failure

Lupron Injection (leuprolide acetate) Prescribing Information	ADVERSE REACTIONS Postmarketing Cardiovascular System Myocardial Infarction Endocrine System Diabetes

OsmoPrep (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Prescribing Information	ADVERSE REACTIONS Postmarketing Experience

Rituxan (rituximab) Prescribing Information	ADVERSE REACTIONS Postmarketing Reports Infection ...and a reported increased incidence of Grade 3 and 4 infections in patients with previously treated lymphoma without known HIV infection. Neoplasia Disease progression of Kaposi's Sarcoma

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Brand (Generic) Name

Sections Modified

Humulin R Regular U-500 (Concentrated) Insulin Human Injection, USP (rDNA Origin)

Prescribing Information

Patient Package Insert

PATIENT PACKAGE INSERT

Common Problems of Diabetes
- Hypoglycemia (Low Blood Sugar)
  - Interactions with other drugs that lower blood glucose
    - ...some kidney and blood pressure medicines.

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