The detailed view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. The prescribing information may be accessed by clicking on the drug name.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Activella (estradiol/norethindrone acetate tablets)

(click product name to read prescribing information)

BOXED WARNING

WARNINGS

• Cardiovascular Disorders.
  • Coronary Heart Disease and Stroke
  • Venous Thromboembolism (VTE)
• Malignant Neoplasms
  • Endometrial Cancer
  • Breast Cancer
• Dementia

PRECAUTIONS

• General
  • Addition of a Progestin when a Woman has not had a Hysterectomy
  • Elevated Blood Pressure
  • Hypertriglyceridemia
  • Impaired Liver Function and Past History of Cholestatic Jaundice
  • Hypothyroidism
  • Fluid Retention
  • Hypocalcemia
  • Ovarian Cancer
  • Exacerbation of Endometriosis
  • Exacerbation of Other Conditions
• Carcinogenesis, Mutagenesis, Impairment of Fertility
• Geriatric Use

ADVERSE REACTIONS

• Initial Paragraph
• Genitourinary System
  • Dysmenorrhea
  • Ovarian cancer
  • Endometrial Hyperplasia 
  • Endometrial Cancer
• Breasts

  • Pain

  • Galactorrhea

  • Nipple Discharge

  • Fibrocystic Breast Changes

  • Breast Cancer

• Cardiovascular

  • Deep and Superficial Venous Thrombosis

  • Myocardial Infarction

  • Stroke

  • Increase in Blood Pressure

• Gastrointestinal

  • Pancreatitis

  • Enlargement of Hepatic Hemangiomas

• Skin

  • Seborrhea

• Eyes

  • Retinal Vascular Thrombosis

• Central Nervous System

  • Mood Disturbances

  • Irritability

  • Exacerbation of Epilepsy 

  • Probable Dementia

• Miscellaneous

  • Leg Cramps

  • Reduced Carbohydrate Tolerance

  • Anaphylactoid/Anaphylactic Reactions

  • Hypocalcemia

  • Exacerbation of Asthma

  • Increased Triglycerides

PATIENT PACKAGE INSERT

Activella should not be used in women with any of the following conditions:

• Known or suspected pregnancy. There is no indication for Activella in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.....

BOXED WARNING

See attached labeling for revised BOXED WARNING.

WARNINGS

Cardiovascular Disorders

.....Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.

Coronary Heart Disease and Stroke

In the Women's Health Initiative (WHI) study, an increased risk of stroke was observed in women receiving CE compared to placebo.....

Venous Thromboembolism (VTE)

In the Women's Health Initiative (WHI) study, an increased risk of deep vein thrombosis was observed in women receiving CE compared to placebo.

In the CE/MPA substudy of WHI, a 2-fold greater rate of VTE, including deep venous thrombosis and pulmonary embolism, was observed in women receiving CE/MPA compared to women receiving placebo. The rate of VTE was 34 per 10,000 women-years in the CE/MPA group compared to 16 per 10,000 women-years in the placebo group. The increase in VTE risk was observed during the first year and persisted....

Malignant Neoplasms - Endometrial Cancer

.....Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.

Malignant Neoplasms - Breast Cancer

Duramorph (morphine sulfate injection, USP) Preservative-Free 

(click product name to read prescribing information)

ADVERSE REACTIONS

• Other

  • Hypotension

  • Confusion

  • Reduced Male Potency

  • Decreased Libido in Men and Women

  •  Menstrual Irregularities Including Amenorrhea

Duramorph, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has already been compromised by a depleted blood volume or a concurrent administration of drugs, such as phenothiazines or general anesthetics.

Nutropin [somatropin (rDNA origin) for injection]

(click product name to read prescribing information)

WARNINGS

PRECAUTIONS

• General
  • Idiopathic Short Stature
• Idiopathic Short Stature - Mean Glucose Levels and Mean Hemoglobin A1c Levels

ADVERSE REACTIONS

• Initial Paragraph
• Post-marketing Surveillance Study (National Cooperative Growth Study)
  • Protocol-Defined Targeted Adverse Events in the ISS NCGS Cohort

CONTRAINDICATIONS & WARNINGS

.....Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, Nutropin is not  indicated for the long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Nutropin AQ [somatropin (rDNA origin) injection]

(click product name to read prescribing information)

WARNINGS

PRECAUTIONS

• General
  • Idiopathic Short Stature
• Idiopathic Short Stature - Mean Glucose Levels and Mean Hemoglobin A1c Levels

ADVERSE REACTIONS

• Initial Paragraph
• Post-marketing Surveillance Study (National Cooperative Growth Study) 
  • Protocol-Defined Targeted Adverse Events in the ISS NCGS Cohort

CONTRAINDICATIONS & WARNINGS

.....Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, Nutropin AQ is not indicated for the long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Climara (estradiol transdermal system)

(click product name to read prescribing information)

• Cardiovascular and Other Risks

WARNINGS

• Cardiovascular Disorders
  • Coronary Heart Disease and Stroke
  • Venous thromboembolism (VTE)

PRECAUTIONS

• General
  • Ovarian Cancer

PATIENT PACKAGE INSERT

Cardiovascular and Other Risks

Estrogens with and without progestins should not be used for the prevention of cardiovascular disease or dementia.

WARNINGS

Cardiovascular Disorders

Coronary Heart Disease and Stroke

In the Women's Health Initiative (WHI) study, an increased risk of stroke was observed in women receiving oral CE compared to placebo.

Venous thromboembolism (VTE)

In the Women's Health Initiative (WHI) study, an increased risk of deep vein thrombosis was observed in women receiving CE compared to placebo.

Climara Pro (estradiol/levonorgestrel transdermal system)

(click product name to read prescribing information)

WARNINGS

• Cardiovascular Disorders
  • Coronary Heart Disease and Stroke
  • Venous thromboembolism (VTE)

PRECAUTIONS

• General
  • Ovarian Cancer

PATIENT PACKAGE INSERT

Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia.

WARNINGS

Cardiovascular Disorders

Coronary Heart Disease and Stroke

In the Women's Health Initiative (WHI) study, an increased risk of deep vein thrombosis was observed in women receiving CE compared to placebo.

Clozaril (clozapine) Tablets

(click product name to read prescribing information)

BOXED WARNING

• Increased Mortality in Elderly Patients with Dementia-Related Psychosis

WARNINGS

• General

  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis

 BOXED WARNING

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infections (e.g., pneumonia) in nature. Clozaril is not approved for the treatment of patients with dementia-related psychosis.

WARNINGS

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Clozaril is not approved for the treatment of patients with dementia-related psychosis.

(click product name to read prescribing information)

BOXED WARNING

WARNINGS

• Patients Co-infected with HIV and Hepatitis B Virus

BOXED WARNING

Emtriva is not indicated for the treatment of chronic hepatitis B Virus (HBV) infection and the safety and efficacy of Emtriva have not been established in patients co-inefected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtriva. Hepatic function should be monitored closely both clinical and laboratory follow-up for at least several months in patients who discontinue Emtriva and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

WARNINGS

It is recommended that all patients with HIV be tested for the presence of chronic hepatitis B virus (HBV) before initiating antiretroviral therapy..... 

Prempro (conjugated estrogens/medroxyprogesterone acetate tablets)

Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)

(click product name to read prescribing information)

WARNINGS

• Cardiovascular Disorders
  • Coronary Heart Disease and Stroke
  • Venous thromboembolism (VTE)
• Malignant Neoplasms
  • Endometrial Cancer
• Dementia

• General
  • Exacerbation of Endometriosis
• Geriatric Use

The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with conjugated estrogens combined with medroxyprogesterone acetate and during 5.2 years of treatment with conjugated estrogens alone, relative to placebo..... 

WARNINGS

Cardiovascular Disorders

Coronary Heart Disease and Stroke

.....In the same estrogen plus progestin substudy of WHI, an increased risk of stroke was observed in women receiving Prempro compared to women receiving placebo (29 vs 21 per 10,000 women-years). The increase in risk was observed after the first year and persisted.

In the estrogen alone substudy of the WHI study, an increased risk of stroke was observed in women receiving Premarin (0.625 mg conjugated estrogens) per day compared to women receiving placebo (44 vs 32 per 10,000 women-years). The increase in risk was observed in year one and persisted.

Venous thromboembolism (VTE)

In the estrogen alone substudy of the WHI study, an increased risk of deep vein thrombosis was observed in women receiving Premarin compared to placebo (21 vs 15 per 10,000 women-years). The increase in VTE was observed during the first year.

Malignant Neoplasms/Endometrial Cancer

The use of unopposed estrogens in women with intact uteri has been associated with an increased risk of endometrial cancer.....

Dementia

.....In the estrogen plus progestin substudy, after an average follow-up of 4 years, 40 women in the estrogen plus progestin group and 21 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for estrogen plus progestin versus placebo was 2.05 (95% CI 1.21-3.48). The absolute risk of probable dementia for Prempro versus placebo was 45 versus 22 cases per 10,000 women-years..... 

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Camptosar (irinotecan hydrochloride injection)

(click product name to read prescribing information)

• Patients with Reduced UGT1A1 Activity

   

Individuals who are homozygous for the UGT1A1*28 allele are at increased risk for neutropenia following initiation of Camptosar treatment. A reduced initial dose should be considered for patients known to be homozygous for the UGT1A1*28 allele. Heterozygous patients (carriers of one variant allele and one wild-type allele which results in intermediate UGT1A1 activity) may be at increased risk for neutropenia; however, clinical results have been variable and such patients have been shown to tolerate normal starting doses.

FazaClo (clozapine, USP) Orally Disintegrating Tablets

(click product name to read prescribing information)

WARNINGS

• General

(click product name to read prescribing information)

PRECAUTIONS

• Drug Interactions 

ADVERSE REACTIONS

• Early

.....The serum calcium times serum phosphorus (Ca X P) product should be maintained at <55 mg²/dL² in patients with chronic kidney disease.....

.....If hypercalcemia occurs after initiating Hectorol therapy, the dose of Hectorol and/or calcium-containing phosphate binders should be decreased. If hyperphosphatemia occurs after initiating Hectorol, the dose of Hectorol should be decreased and/or the dose of phosphate binders increased. 

Keppra (levetiracetam) Tablets and Oral Solution

(click product name to read prescribing information)

• Neuropsychiatric Adverse Events
  • Pediatric Patients

PRECAUTIONS

• Hematologic Abnormalities
  • Pediatric Patients
• Hepatic Abnormalities
• Drug Interactions
  • Drug-Drug Interactions Between Keppra And Other Antiepileptic Drugs (AEDs)
    • Effect of AEDs in Pediatric Patients
• Pediatric Use

ADVERSE REACTIONS

• Table 6
• Table 8

In pediatric patients, Keppra is associated with somnolence, fatigue, and behavioral abnormalities.....

Mevacor (lovastatin) Tablets

(click product name to read prescribing information)

• Myopathy/Rhabdomyolysis
  • Potent Inhibitors of CYP3A4
    • Telithromycin
  • Danazol

PRECAUTIONS

• Drug Interactions
  • CYP3A4 Interactions
    • Telithromycin 
  • Other Drug Interactions
    • Danazol

• Potent Inhibitors of CYP3A4 - (the drug Telithromycin added to the list)
• Danazol, particularly with higher doses of lovastatin

Use of lovastatin concomitantly with itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or large quantities of grapefruit juice (>1 quart daily) should be avoided. (Telithromycin was added to the list).

The dose of lovastatin should not exceed 20 mg daily in patients receiving concomitant medication with danazol. The benefits of the use of lovastatin in patients receiving danazol should be carefully weighed against the risk of this combination.

Pulmicort Respules (budesonide inhalation suspension)

(click product name to read prescribing information)

PRECAUTIONS

• Information to Patients
  • Chicken Pox and Measles 

Patients who are on drugs which suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible pediatric patients or adults on immunosuppressant doses of corticosteroids. In pediatric or adult patients who have not had these diseases, or who have not been properly vaccinated, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known.....

Raptiva (efalizumab]) for Injection, Subcutaneous

(click product name to read prescribing information)

• Serious Infection
• Immune-Mediated Thrombocytopenia
• Immune-Mediated Hemolytic Anemia
• Psoriasis Worsening and Varients

PRECAUTIONS

• Arthritis Events
• Information for Patients
• Pregnancy Category C

ADVERSE REACTIONS

• Initial Paragraph
  • Hemolytic Anemia
  • Arthritis Events
• Immune-Mediated Thrombocytopenia
• Immune-Mediated Hemolytic Anemia
• Arthritis Events
• Inflammatory/Immune-Mediated Reactions
  • Myositis
  • Eosinophilic Pneumonitis
• Postmarketing Experience
  • Toxic Epidermal Necrolysis
  • Photosensitivity Reactions

PATIENT PACKAGE INSERT

Serious Infection

.....Postmarketing reports of serious infections include necrotizing fasciitis and tuberculous pneumonia.  Bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia (ANC 60/mm³), and worsening of infection (e.g. cellulitis, pneumonia) despite antimicrobial treatment have been observed.

Immune-Mediated Thrombyocytopenia

Platelet counts at or below 52,000 cells per mL were observed in 8 (0.3%) Raptiva treated patients during clinical trials compared with none among the placebo treated patients. Five of the 8 patients received a course of systemic steroids for thrombocytopenia.....

Immune-Mediated Hemolytic Anemia

Reports of hemolytic anemia, some serious, diagnosed 4-6 months after the start of Raptiva treatment have been received.  Raptiva should be discontinued if hemolytic anemia occurs.

Psoriasis Worsening and Varients

.....In some patients these events took the form of psoriatic erythroderma, pustular psoriasis, or development of new plaque lesions.....

For additional details, see MedWatch 07/20/2005 Safety Alert 

Topamax (topiramate) Tablets

Topamax (topiramate capsules) Sprinkle Capsules

(click product name to read prescribing information)

• Metabolic Acidosis
• Cognitive/Neuropsychiatric Adverse Events
  • Cognitive-Related Dysfunction
  • Somnolence/Fatigue
  • Pediatric Patients

PRECAUTIONS

• Kidney Stones
• Paresthesia
• Pediatric Use

ADVERSE REACTIONS

• Monotherapy Epilepsy
• Table 4
• Table 5

• Other Adverse Events Observed During All Epilepsy Clinical Trials

• Gastrointestinal System Disorders

  • Tongue Edema (Rare)

• Metabolic and Nutritional Disorders

  • Dehydration

  • Diabetes Mellitus

• Platelet, Bleeding, and Clotting Disorders

  • Pulmonary Embolism

• Psychiatric Disorders

  • Euphoria

Metabolic Acidosis

In adults, the incidence of persistent treatment-emergent decreases in serum bicarbonate (levels of <20 mEq/L at two consecutive visits or at the final visit) in controlled clinical trials for adjunctive treatment of epilepsy was 32% for 400 mg/day, and 1% for placebo. Metabolic  acidosis has been observed at doses as low as 50 mg/day.....

.....In pediatric patients (10 years up to 16 years of age), the incidence of persistent treatment-emergent decreases in serum bicarbonate in the epilepsy controlled clinical trial for monotherapy was 7% for 50 mg/day and 20% for 400mg/day. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value <17 mEq/L and >5mEq/L decrease from pretreatment) in this trial was 4% for 50 mg/day and 4% for 400 mg/day. 

Cognitive/Neuropsychiatric Adverse Events

Cognitive-Related Dysfunction

In the monotherapy epilepsy controlled trial, the proportion of patients who experienced one or more cognitive-related adverse events was 19% for Topamax 50 mg/day and 26% for 400 mg/day. 

Somnolence/Fatigue

.....For the monotherapy epilepsy population in the 50 mg/day and 400 mg/day groups, the incidence of somnolence was dose-related  (9% for the 50 mg/day group and 15% for the 400 mg/day group) and the incidence of fatigue was comparable in both treatment groups.....

Pediatric Patients

.....The most frequently reported neuropsychiatric events in pediatric patients during adjunctive therapy double-blind studies were somnolence and fatigue. The most frequently reported neuropsychiatric events in pediatric patients in the 50 mg/day and 400 mg/day groups during the monotherapy double-blind study were headache, dizziness anorexia, and somnolence..... 

(click product name to read prescribing information)

• Myopathy/Rhabdomyolysis
  • Potent Inhibitors of CYP3A4
    • Telithromycin
  • Other Drugs
    • Danazol

PRECAUTIONS

• Drug Interactions
  • CYP3A4 Interactions
    • Telithromycin
• Other Drug Interactions
  • Danazol 
  • Amiodarone or Verapamil

ADVERSE REACTIONS

• Ezetimibe
  • Post-marketing Experience

    • Increased CPK

    • Eelevations in Liver Transaminases

    • Hepatitis

    • Thrombocytopenia

    • Rhabdomyolysis (very rarely in patients taking an HMG-CoA reductase inhibitor with ezetimibe)

PATIENT PACKAGE INSERT

Because Vytorin contains simvastatin, the risk of myopathy/rhabdomyolysis is increased by concomitant use of Vytorin with the following:

• Potent Inhibitors of CYP3A4 - (the drug Telithromycin added to the list)
• Danazol, particularly with higher doses of Vytorin

(click product name to read prescribing information)

• Adjuvant Colon Cancer

  • Table 11

  • Table 12

• Metastatic Colorectal Cancer

• Xeloda Monotherapy Metastatic Breast and Colorectal Cancer

  • Postmarketing

    • Lacrimal Duct Stenosis

.....In 875 patients with either metastatic breast or colorectal cancer who received Xeloda monotherapy, the median time to first occurrence of grade 2 to 4 diarrhea was 34 days (range from 1 to 369 days).....

.....In 875 patients with either metastatic breast or colorectal cancer who received Xeloda monotherapy, 62% of the 21 patients ≥80 years of age treated with Xeloda experienced a treatment-related grade 3 or 4 adverse event: diarrhea in 6 (28.6%), nausea in 3 (14.3%), hand-and-foot syndrome in 3 (14.3%), and vomiting in 2 (9.5%) patients.....

(click product name to read prescribing information)

• General
  • Administration of Live Vaccines to Immunocompromised Patients Should Be Avoided.

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• Drug Interactions 
• Geriatric Use

ADVERSE REACTIONS

• Initial Paragraph

(click product name to read prescribing information)

• Geriatric Use

5% Dextrose and Electrolyte No. 48 Injection 

(Multiple Electrolytes and Dextrose Injection, Type 1, USP)

(click product name to read prescribing information)

• Geriatric Use

(Multiple Electrolytes and Dextrose Injection, Type 3, USP)

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

• Drug Interactions
  • 5-HT₃ antagonists

(click product name to read prescribing information)

• Drug Interactions
  • Sulfasalazine
• Pregnancy (Category B)

PATIENT PACKAGE INSERT

(click product name to read prescribing information)

• Immune Reconstitution Syndrome

PATIENT PACKAGE INSERT

Hectorol (doxercalciferol) Capsules

(click product name to read prescribing information)

• Drug Interactions

  • Cytochrome P450 Inhibitors 

• Drug Interactions
  • Table 13
    • Non-nucleoside Reverse Transcriptase Inhibitor: Nevirapine

Niaspan (niacin extended-release tablets)

(click product name to read prescribing information)

• Geriatric Use

ADVERSE REACTIONS

• Body as a Whole
  • Generalized Edema
  • Face Edema
  • Peripheral Edema
• Gastrointestinal
  • Eructation
  •  Fatulence
• Musculoskeletal
  • Myasthenia
• Nervous
  • Leg Cramps
  • Nervousness
  • Paresthesia

Osmitrol (mannitol injection, USP) 

(click product name to read prescribing information)

PRECAUTIONS

• Geriatric Use

(click product name to read prescribing information)

• Geriatric Use

(click product name to read prescribing information)

PRECAUTIONS

• Geriatric Use

(click product name to read prescribing information)

• Drug Interactions

  • Drugs Which May Be Coadministered Without Dose Adjustment

    • Atorvastatin

(click product name to read prescribing information)

• Immunization

3% and 5% Sodium Chloride Injection, USP

(click product name to read prescribing information)

• Geriatric Use

Please contact GE Healthcare at 1-800-437-1171 for prescribing information.

• Geriatric Use

Clinical studies of Sodium Iodide I 123 (Sodium Iodide I-123 Capsules) did not include sufficient numbers of subject aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Ultane (sevoflurane) Volatile Liquid for Inhalation

(click product name to read prescribing information)

• Desiccated CO₂ Absorbents

(click product name to read prescribing information)

• Hypersensitivity Reactions

• Geriatric Use

ADVERSE REACTIONS

• Adverse Events Observed in All Treated Populations

• Adverse Events Observed in Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD) Patients

• Hypersensitivity Reactions

Zosyn (piperacillin and tazobactam for injection)

(click product name to read prescribing information)

• Drug Interactions
  • Aminoglycosides

Accolate (zafirlukast) Tablets

(click product name to read prescribing information)

• Adults and Children 12 Years of Age and Older
  • Insomnia
  • Malaise
  • Pruritis

Alinia (nitazoxanide) Tablets and for Oral Suspension

(click product name to read prescribing information)

ADVERSE REACTIONS

• Alinia Tablets
• Alinia for Oral Suspension

Avelox (moxifloxacin hydrochloride) Tablets

Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection)

(click product name to read prescribing information)

• Initial Section
• Body as a Whole
• Cardiovascular
• Nervous System
• Digestive
• Hemic and Lymphatic
• Metabolic and Nutritional
• Musculoskeletal
• Skin/Appendages
• Urogenital
• Additional Clinically Relevant Rare Events
• Post-Marketing Adverse Event Reports
  • Hepatitis (Predominantly Cholestatic)
  • Psychotic Reaction
  • Stevens-Johnson Syndrome
  • Tendon Rupture

Nexium (esomeprazole magnesium) Delayed-Release Capsules

(click product name to read prescribing information)

• Postmarketing Reports
  • Myalgia
  • Hepatitis with or without jaundice (very rarely)

Singulair (montelukast sodium) Tablets, Chewable Tablets and Oral Granules

(click product name to read prescribing information)

• Post-Marketing Experience - Rare Cases of:
  • Cholestatic Hepatitis
  • Hepatocellular Liver-Injury
  • Mixed-Pattern Liver Injury

FDA/CDER/OCD/Safety Policy and Communication Staff
Web page last revised by jlw August 24, 2005