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.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Tracleer (bosentan) Film-Coated Tablets

Prescribing Information

BOXED WARNING

• Potential Liver Injury

ADVERSE REACTIONS

• Postmarketing Experience
  • There have also been rare reports of liver failure.

BOXED WARNING: Potential Liver Injury

...There have also been rare reports of liver failure...

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Desogen (desogestrel and ethinyl estradiol) Tablets

Prescribing Information

Patient Package Insert

CONTRAINDICATIONS

WARNINGS

• Initial Section
• Thromboembolic Disorders and Other Vascular Problems
  • Thromboembolism
  • Myocardial Infarction
    • Table 2
  • Cerebrovascular Diseases
• Estimates of Mortality from Contraceptive Use
• Carcinoma of the Reproductive Organs and Breasts
• Oral Contraceptive Use Before or During Early Pregnancy
• Elevated Blood Pressure
• Bleeding Irregularities

PRECAUTIONS

• Lipid Disorders
• Liver Function
• Emotional Disorders
• Drug Interactions
  • Changes in contraceptive effectiveness associated with co-administration of other drugs
    • Anti-infective Agents and Anticonvulsants
    • Herbal Products
  • Changes in Plasma Levels of Co-administered Drugs

ADVERSE REACTIONS

• The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related...
• The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted...

PATIENT PACKAGE INSERT

• Brief Summary
• Detailed Patient Package Insert

CONTRAINDICATIONS & WARNINGS

See highlighted prescribing information for new text.

Lexiva (fosamprenavir calcium) Tablets and Oral Suspension

Prescribing Information (in new labeling format)

Patient Package Insert

CONTRAINDICATIONS

ADVERSE REACTIONS

• Clinical Trials in Pediatric Patients

DRUG INTERACTIONS

• Established and Other Potentially Significant Drug Interactions
• Table 7
  • Other Agents
    • Antidepressant
• Paroxetine
• HMG-CoA Reductase Inhibitor
  • Rosuvastatin
• Inhaled/Nasal Steroid
  • Fluticasone
• PDE5 Inhibitors
  • Tadalafil

USE IN SPECIFIC POPULATIONS

• Pediatric Use
• Hepatic Impairment

PATIENT COUNSELING INFORMATION

• Oral Suspension

PATIENT PACKAGE INSERT

• What is Lexiva?
• Who should not take Lexiva?
• How should I take Lexiva?
• What are the ingredients in Lexiva?
  • Oral Suspension

CONTRAINDICATIONS

Lexiva is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson Syndrome) to any of the components of this product or to amprenavir...

Prevacid (lansoprazole) Delayed-Release Capsules

Prevacid (lansoprazole) for Delayed-Release Oral Suspension

Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets

Prescribing Information

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

• General
  • For information about precautions of other drugs that may be used in combination with amoxicillin or clarithromycin, refer to the PRECAUTIONS section of their package inserts.
• Drug Interactions
  • ..Therefore, proton pump inhibitors should be taken at least 30 minutes prior to sucralfate. In clinical trials, antacids were administered concomitantly with Prevacid and there was no evidence of a change in the efficacy of Prevacid...

ADVERSE REACTIONS

• Postmarketing
  • Body as a Whole
    • Anaphylactic/Anaphylactoid Reactions
  • Musculoskeletal System
    • Myositis
  • Urogenital System
    • Interstitial Nephritis

CONTRAINDICATIONS

Prevacid is contraindicated in patients with known severe hypersensitivity to any component of the formulation of Prevacid.

Concomitant administration of clarithromycin and any of the following drugs is contraindicated: cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine...

For information about contraindications of other drugs that may be used in combination with amoxicillin or clarithromycin, refer to the CONTRAINDICATIONS section of their package inserts...

WARNINGS

There have been postmarketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients.

...For information about warnings of other drugs that may be used in combination with amoxicillin or clarithromycin, refer to the WARNINGS section of their package inserts.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Bactrim (sulfamethoxale and trimethoprim DS [double strength] Tablets and Tablets, USP)

Prescribing Information

WARNINGS

• Clostridium difficile associated diarrhea (CDAD)

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)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Bactrim, 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.

Betoptic S (betaxolol hydrochloride ophthalmic suspension) 0.25% as base, Sterile Topical Ophthalmic Drops

Prescribing Information (in new labeling format)

WARNINGS & PRECAUTIONS

• General
• Surgical Anesthesia
• Angle-Closure Glaucoma
• Cerebrovascular Insufficiency
• Bacterial Keratitis
• Choroidal Detachment
  • Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy.

ADVERSE REACTIONS

• Clinical Studies Experience

DRUG INTERACTIONS

• Catecholamine-Depleting Drugs

USE IN SPECIFIC POPULATIONS

• Pediatric Use

PATIENT COUNSELING INFORMATION

• How to Use the Drop-Tainer Bottle

WARNINGS & PRECAUTIONS: General

As with many topically applied ophthalmic drugs, this drug is absorbed systemically...

...For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and death due to cardiac failure, have been reported with topical application of beta-adrenergic receptor inhibitors.

WARNINGS & PRECAUTIONS: Surgical Anesthesia

The necessity or desirability of withdrawal of beta-adrenergic receptor inhibitors prior to major surgery is controversial. Beta-adrenergic receptor inhibitors impair the ability of the heart to respond to beta-adrenergically mediated reflex stimuli...

WARNINGS & PRECAUTIONS: Angle-Closure Glaucoma

In patients with angle-closure glaucoma, the immediate treatment objective is to reopen the angle. This may require constricting the pupil. Betaxolol has little or no effect on the pupil and should not be used alone in the treatment of angle-closure glaucoma.

WARNINGS & PRECAUTIONS: Cerebrovascular Insufficiency

Because of potential effects of beta-adrenergic receptor inhibitors on blood pressure and pulse, these agents should be used with caution in patients with cerebrovascular insufficiency. If signs and symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with Betoptic S, alternative therapy should be considered.

WARNINGS & PRECAUTIONS: Bacterial Keratitis

Bacterial keratitis may occur with use of multiple dose containers of topical ophthalmic products when these containers are inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Instruct patients on appropriate instillation techniques.

Cipro I.V. (ciprofloxacin)

Prescribing Information

WARNINGS

• Hypersensitivity Reactions
• Pseudomembranous Colitis
  • Clostridium difficile associated diarrhea (CDAD)

PRECAUTIONS

• Information for Patients
  • ...The risk of serious tendon disorders with quinolones is higher in those over 65 years of age, especially those on corticosteroids.
  • 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.
• Geriatric Use
  • In general, elderly patients may be more susceptible to drug-associated effects on the QT interval...
  • Patients over 65 years of age are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Cipro...

ADVERSE REACTIONS

• Postmarketing Adverse Events
  • Hepatic Failure (including fatal cases)

WARNINGS: Hypersensitivity Reactions

...Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including ciprofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

• fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome);
• vasculitis, arthralgia, myalgia, serum sickness;
• allergic pneumonitis;
• interstitial nephritis; acute renal insufficiency or failure;
• hepatitis; jaundice; acute hepatic necrosis or failure;
• anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.

WARNINGS: Pseudomembranous Colitis

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cipro, 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.

Cipro (ciprofloxacin hydrochloride) Tablets

Cipro (ciprofloxacin) Oral Suspension

Prescribing Information

Patient Package Insert

WARNINGS

• Hypersensitivity Reactions
• Pseudomembranous Colitis: Clostridium difficile

PRECAUTIONS

• Information for Patients
  • ...The risk of serious tendon disorders with quinolones is higher in those over 65 years of age, especially those on corticosteroids.
  • 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.
• Geriatric Use
  • In general, elderly patients may be more susceptible to drug-associated effects on the QT interval...
  • Patients over 65 years of age are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Cipro...

ADVERSE REACTIONS

• Postmarketing Adverse Events
  • Hepatic Failure (including fatal cases)

PATIENT PACKAGE INSERT

• What are the possible side effects of Cipro?
  • Pain, swelling, and tears of Achilles, shoulder, or hand tendons have been reported...
  • Diarrhea that usually ends after treatment is a common problem caused by antibiotics...

WARNINGS: Hypersensitivity Reactions

...Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including ciprofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

• fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome);
• vasculitis, arthralgia, myalgia, serum sickness;
• allergic pneumonitis;
• interstitial nephritis; acute renal insufficiency or failure;
• hepatitis; jaundice; acute hepatic necrosis or failure;
• anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.

WARNINGS: Pseudomembranous Colitis

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cipro, 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.

Cipro XR (ciprofloxacin extended-release tablets)

Prescribing Information

Patient Package Insert

WARNINGS

• Hypersensitivity Reactions
• Clostridium difficile associated Diarrhea (CDAD)

PRECAUTIONS

• Information for Patients
  • to discontinue Cipro XR treatment; rest and refrain from exercise; and inform their physician if they experience pain, inflammation, or rupture of a tendon. The risk of serious tendon disorders with quinolones is higher in those over 65 years of age, especially those on corticosteroids.
  • 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.
• Geriatric Use
  • In general, elderly patients may be more susceptible to drug-associated effects on the QT interval...
  • Patients over 65 years of age are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Cipro...

ADVERSE REACTIONS

• Postmarketing Adverse Events
  • Hepatic Failure (including fatal cases)

PATIENT PACKAGE INSERT

• What are the possible side effects of Cipro XR?
  • Pain, swelling, and tears of Achilles, shoulder, or hand tendons have been reported...
  • Diarrhea that usually ends after treatment is a common problem caused by antibiotics...

WARNINGS: Hypersensitivity Reactions

...Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including ciprofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

• fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome);
• vasculitis, arthralgia, myalgia, serum sickness;
• allergic pneumonitis;
• interstitial nephritis; acute renal insufficiency or failure;
• hepatitis; jaundice; acute hepatic necrosis or failure;
• anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.

WARNINGS: Clostridium difficile associated Diarrhea (CDAD)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cipro, 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.

Copegus (ribavirin, USP) Tablets

Prescribing Information

Medication Guide

WARNINGS

• Hypersensitivity

ADVERSE REACTIONS

• Psychotic Disorder
• Hallucination
• Postmarketing Experience
  • The following adverse reactions have been identified and reported during postapproval use of Pegasys therapy: hearing impairment, hearing loss, and serious skin reactions...

MEDICATION GUIDE

• What are the possible side effects of Copegus?
• What are the ingredients in Copegus?

WARNINGS: Hypersensitivity

...Serious skin reactions including vesiculobullous eruptions, reactions in the spectrum of Stevens Johnson Syndrome (erythema multiforme major) with varying degrees of skin and mucosal involvement and exfoliative dermatitis (erythroderma) have been rarely reported in patients receiving Pegasys with and without ribavirin. Patients developing signs or symptoms of severe skin reactions must discontinue therapy...

Duricef (cefadroxil monohydrate, USP) Powder, for Suspension

Duricef (cefadroxil monohydrate, USP) Tablets and Capsules

Prescribing Information

WARNINGS

• Clostridium difficile associated Diarrhea (CDAD)

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)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Duricef, 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.

Prescribing Information

Patient Package Insert

WARNINGS

• Hypersensitivity Reactions
• Tendon Effects

PRECAUTIONS

• Information for Patients
  • ...The risk of serious tendon disorders is higher in those over 65 years of age, especially those on steroids
  • to inform their physician of any personal or family history of QTc prolongation or proarrhythmic conditions...
• Geriatric Use
  • Patients over 65 years of age are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Floxin...

ADVERSE REACTIONS

• Postmarketing Adverse Events
  • Cardiovascular System
    • Torsades de pointes
  • Gastrointestinal System
    • Hepatic Failure (including fatal cases)
  • Skin/Hypersensitivity
    • Toxic Epidermal Necrolysis

PATIENT PACKAGE INSERT

• What are possible side effects of Floxin? (new)

WARNINGS: Hypersensitivity Reactions

...Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including ofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

• fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome);
• vasculitis, arthralgia, myalgia, serum sickness;
• allergic pneumonitis;
• interstitial nephritis; acute renal insufficiency or failure;
• hepatitis; jaundice; acute hepatic necrosis or failure;
• anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.

WARNINGS: Tendon Effects

...Postmarketing surveillance reports indicate that the risk is increased in patients receiving corticosteroids, especially the elderly...

Lescol (fluvastatin sodium) Capsules

Lescol XL (fluvastatin sodium) Extended-Release Tablets

Prescribing Information

WARNINGS

• Skeletal Muscle

WARNINGS: Skeletal Muscle

...Isolated cases of myopathy have been reported during postmarketing experience with concomitant administration of fluvastatin and colchicine. No information is available on the pharmacokinetic interaction between fluvastatin and colchicine. However, myotoxicity, including muscle pain and weakness and rhabdomyloysis, have been reported anecdotally with concomitant administration of colchicine.

Levaquin (levofloxacin) Tablets and Oral Solution

Levaquin (levofloxacin) Injection

Levaquin (levofloxacin in 5% dextrose) Injection

Prescribing Information

Patient Package Insert

WARNINGS

• Hypersensitivity Reactions
• Tendon Effects

PRECAUTIONS

• Information for Patients
  • ...The risk of serious tendon disorders is higher in those over 65 years of age, especially those on steroids
  • to inform their physician of any personal or family history of QTc prolongation or proarrhythmic conditions...
• Geriatric Use
  • Patients over 65 are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Levaquin...

ADVERSE REACTIONS

• Postmarketing Adverse Reactions
  • Hepatic Failure (including fatal cases)

PATIENT PACKAGE INSERT

• What are possible side effects of Levaquin?

WARNINGS: Hypersensitivity Reactions

...Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including Levaquin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

• fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome);
• vasculitis, arthralgia, myalgia, serum sickness;
• allergic pneumonitis;
• interstitial nephritis; acute renal insufficiency or failure;
• hepatitis; jaundice; acute hepatic necrosis or failure;
• anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.

WARNINGS: Tendon Effects

...Postmarketing surveillance reports indicate that this risk is increased in patients receiving concomitant corticosteroids, especially the elderly...

Lyrica (pregabalin) Capsules

Prescribing Information (in new labeling format)

Patient Package Insert

WARNINGS & PRECAUTIONS

• Angioedema
• Hypersensitivity
• Peripheral Edema
• Dizziness and Somnolence
• Weight Gain
• Ophthalmological Effects
• Creatine Kinase Elevations
• Decreased Platelet Count

ADVERSE REACTIONS

• Controlled Studies with Fibromyalgia
  • Adverse Reactions Leading to Discontinuation
  • Most Common Adverse Reactions
    • Table 5
• Other Adverse Reactions Observed During the Clinical Studies of Lyrica
  • Digestive System
    • Periodontal Abscess
  • Musculoskeletal Syndrome
    • Chondrodystrophy
  • Skin and Appendages
    • Nail Disorder
  • Urogenital System
    • Urine Abnormality
    • Ovarian Disorder
    • Pyelonephritis
• Postmarketing Experience
  • Nervous System Disorder
    • Headache
  • Gastrointestinal Disorder
    • Nausea
    • Diarrhea

USE IN SPECIFIC POPULATIONS

• Pediatric Use
• Geriatric Use
  • Neuropathic pain associated with diabetic peripheral neuropathy
  • Fibromyalgia

PATIENT COUNSELING INFORMATION

• Angioedema
• Hypersensitivity

PATIENT PACKAGE INSERT

• What is the most important information I should know about Lyrica?
• What is Lyrica?
• What should I tell my doctor before taking Lyrica?
• What are the possible side effects of Lyrica?

WARNINGS & PRECAUTIONS: Angioedema

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with Lyrica. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Lyrica should be discontinued immediately in patients with these symptoms.

Caution should be exercised when prescribing Lyrica to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.

WARNINGS & PRECAUTIONS: Hypersensitivity

There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with Lyrica. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Lyrica should be discontinued immediately in patients with these symptoms.

For additional revisions made to the additional WARNINGS & PRECAUTIONS section, see the highlighted prescribing information.

Macrobid Capsules (nitrofurantoin monohydrate/macrocrytals)

Contact Procter & Gamble Pharmaceuticals, Inc. at 1-800-836-0658 for prescribing information.

WARNINGS

• Clostridium difficile associated Diarrhea (CDAD)

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)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including nitrofurantoin, 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.

Prescribing Information

Medication Guide

WARNINGS

• Infections
• Hypersensitivity

ADVERSE REACTIONS

• In all hepatitis C studies...
  • Psychotic Disorder
  • Hallucination
• Postmarketing Experience
  • ...Serious Skin Reactions

MEDICATION GUIDE

• What is the most important information I should know about Pegasys therapy?

WARNINGS: Infections

While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of high or persistent fever must be ruled out, particularly in patients with neutropenia. Serious and severe infections (bacterial, viral, fungal), some fatal, have been reported during treatment with alpha interferons including Pegasys. Appropriate anti-infective therapy should be started immediately and discontinuation of therapy should be considered.

WARNINGS: Hypersensitivity

...Serious skin reactions including vesiculobullous eruptions, reactions in the spectrum of Stevens Johnson Syndrome (erythema muItiforme major) with varying degrees of skin and mucosal involvement and exfoliative dermatitis (erythroderma) have been rarely reported in patients receiving Pegasys with and without ribavirin. Patients developing signs or symptoms of sevère skin reactions must discontinue therapy.

Pulmicort Respules (budesonide inhalation suspension)

Prescribing Information

WARNINGS

PRECAUTIONS

• General
• Information for Patients
• Carcinogenesis, Mutagenesis, Impairment of Fertility
• Nursing Mothers
• Pediatric Use

ADVERSE REACTIONS

• Less Frequent Adverse Events (<1%)
  • Urticaria
  • Glaucoma
  • Cataracts

WARNINGS

...Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Pulmicort Respules. Lung function (FEV₁ or AM PEF), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic corticosteroid therapy to Pulmicort Respules may unmask allergic or other immunologic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eosinophilic conditions, eczema, and arthritis...

Timolol GFS (timolol maleate ophthalmic gel forming solution), Sterile Topical Ophthalmic Drops

Prescribing Information (in new labeling format)

WARNINGS & PRECAUTIONS

• General
• Bronchospasm and Obstructive Pulmonary Disease
• Surgical Anesthesia
• Bacterial Keratitis
• Choroidal Detachment
  • Choroidal detachment after filtration procedures has been reported with the administration
    of aqueous suppressant (e.g., timolol) therapy.

ADVERSE REACTIONS

• Clinical Studies Experience
• Additional Potential Adverse Reactions Associated with Timolol Maleate
  • Nervous System/Psychiatric
    • Confusion
    • Hallucinations
    • Anxiety
    • Depression
  • Hypersensitivity
    • Anaphylaxis
  • Special Senses
    • Tinnitus

DRUG INTERACTIONS

• Oral Beta-Adrenergic Receptor Inhibitors
• Clonidine

USE IN SPECIFIC POPULATIONS

• Pediatric Use

WARNINGS & PRECAUTIONS: General

...For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and death due to cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate.

WARNINGS & PRECAUTIONS: Bronchospasm and Obstructive Pulmonary Disease

Bronchospasm may occur...

WARNINGS & PRECAUTIONS: Surgical Anesthesia

...In patients undergoing elective surgery, consider gradual withdrawal of beta-adrenergic receptor inhibitors...

WARNINGS & PRECAUTIONS: Bacterial Keratitis

Bacterial keratitis may occur with use of multiple dose containers of topical ophthalmic products when these containers are inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Instruct patients on appropriate instillation techniques...

Vantin (cefpodoxime proxetil) Tablets and Oral Suspension

Contact Pfizer Global Pharmaceuticals, Inc.. at 1-212-733-2323 for prescribing information.

WARNINGS

• Clostridium difficile associated Diarrhea (CDAD)

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)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Vantin, 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.

Adderall (mixed salts of a single-entity amphetamine product) Tablets

Prescribing Information

Medication Guide

PRECAUTIONS

• Information for Patients
  • Medication Guide

MEDICATION GUIDE (new)

Cardene I.V. (nicardipine hydrochloride)

Prescribing Information

PRECAUTIONS

• Geriatric Use

Prescribing Information

Patient and Parent Information

PRECAUTIONS

• General
  • There have been reports of benign intracranial hypertension (or pseudotumor cerebri; PTC) and/or papilledema...
  • There have been reports of serious skin lesions...

ADVERSE REACTIONS

• Postmarketing Surveillance

PATIENT AND PARENT INFORMATION

• What are the possible side effects of Cystagon?

Kaletra (lopinavir/ritonavir) Tablets and Oral Solution

Prescribing Information

PRECAUTIONS

• Drug Interactions
  • Table 11
    • HIV Protease Inhibitor
      • Tipranavir

Methylin Chewable Tablets (methylphenidate HCl chewable tablets)

Prescribing Information

Medication Guide

PRECAUTIONS

• Information for Patients
  • Medication Guide

MEDICATION GUIDE (new)

Prescribing Information

Medication Guide

PRECAUTIONS

• Information for Patients
  • Medication Guide

MEDICATION GUIDE (new)

Omacor (omega-3-acid ethyl esters) Capsules

Prescribing Information

PRECAUTIONS

• Drug Interactions
  • HMG-CoA Reductase Inhibitors
• Geriatric Use

ADVERSE REACTIONS

• Initial Section
  • Table 3
• Additional Adverse Events
  • Infections and Infestations
    • Viral Infection

Prescribing Information

PRECAUTIONS

• Renal
  • ...Patients with preexisting renal disease, increased BUN or serum creatinine, or proteinuria should be carefully monitored, especially during the initial phase of treatment. Mesalamine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.
• Drug Interactions
  • There are no data on interactions between Pentasa and other drugs.
• Nursing Mothers
  • No controlled studies with Pentasa during breast-feeding have been carried out. Hypersensitivity reactions like diarrhea in the infant cannot be excluded.

ADVERSE REACTIONS

• Postmarketing Reports
  • Other
    • Postmarketing reports of pneumonitis, granulocytopenia, systemic lupus erythematosis, acute renal failure, chronic renal failure and angioedema have been received in patients taking Pentasa.

Pulmicort Flexhaler (budesonide inhalation powder) for Oral Inhalation Only

Prescribing Information

PRECAUTIONS

• Nursing Mothers
  • ...Data with budesonide delivered via dry powder inhaler indicates that the total daily oral dose of budesonide available in breast milk to the infant is approximately 0.3% to 1% of the dose inhaled by the mother...
  • No studies have been conducted in breastfeeding women specifically with Pulmicort Flexhaler; however, the dose of budesonide available to the infant in breast milk, as a percentage of the maternal dose, would be expected to be similar. Pulmicort Flexhaler should be used in nursing women only if clinically appropriate...

Tiazac (diltiazem hydrochloride) Extended-Release Capsules

Prescribing Information

PRECAUTIONS

• Drug Interactions
  • Buspirone
  • Quinidine

Omnicef (cefdinir) Capsules

Omnicef (cefdinir) for Oral Suspension

Prescribing Information

ADVERSE REACTIONS

• Postmarketing Experience
  • ...Anaphylaxis with rare cases of fatality...

Plaquenil (hydroxychloroquine sulfate, USP)

Prescribing Information

ADVERSE REACTIONS

• Visual Field Defects
  • Abnormal Color Vision
• Allergic Reactions
  • Urticaria
  • Angioedema
  • Bronchospasm

Prescribing Information

ADVERSE REACTIONS

• Table 11
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
• Postmarketing Adverse Events
  • Interstitial lung disease (including pulmonary fibrosis/interstitial pneumonitis and very rare rapidly progressive disease)
  • Psoriasis (including new onset and pustular, primarily palmar/plantar)

RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent)

Prescribing Information

See MedWatch Safety Alert posted 06/15/2007 for additional information on RotaTeq labeling revisions.

ADVERSE REACTIONS

• Kawasaki Disease
• Postmarketing Reports
  • Infections and infestations
    • Kawasaki Disease

Ansaid (flurbiprofen tablets, USP)

Prescribing Information and Medication Guide

NSAID MEDICATION GUIDE

• Table: NSAID medicines that need a prescription
  • Vicoprofen
  • Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

Celebrex (celecoxib) Capsules

Prescribing Information and Medication Guide

NSAID MEDICATION GUIDE

• Table: NSAID medicines that need a prescription
  • Vicoprofen
  • Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

Combunox (oxycodone HCl and ibuprofen) Tablets

Prescribing Information

Medication Guide

NSAID MEDICATION GUIDE

• Table: NSAID medicines that need a prescription
  • Vicoprofen
  • Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

Daypro (oxaprozin caplets)

Prescribing Information and Medication Guide

NSAID MEDICATION GUIDE

• Table: NSAID medicines that need a prescription
  • Vicoprofen
  • Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

FDA/CDER/Office of Drug Safety
Web page last revised by jlw August 21, 2007