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warnings and cautions
5 WARNINGS AND PRECAUTIONS Risk of Convulsions: Convulsions in infants below the age of 1 year have been reported (5.1). Hematologic Effects: Neutropenia and agranulocytosis have been reported in patients receiving mebendazole at higher doses and for prolonged duration. Monitor blood counts in these patients (5.2). Metronidazole and Serious Skin Reactions: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. Avoid concomitant use of mebendazole and metronidazole (5.3). 5.1 Risk of Convulsions Although EMVERM ® is approved for use in children two years of age and older, convulsions have been reported in infants below the age of 1 year during post-marketing experience with mebendazole, including EMVERM ® [see Adverse Reactions ( 6.2 ) and Use in Specific Populations ( 8.4 )] . 5.2 Hematologic Effects Agranulocytosis and neutropenia have been reported with mebendazole use at higher doses and for more prolonged durations than is recommended for the treatment of soil-transmitted helminth infections. Monitor blood counts if EMVERM ® is used at higher doses or for prolonged duration. 5.3 Metronidazole Drug Interaction and Serious Skin Reactions Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. Avoid concomitant use of mebendazole, including EMVERM ® and metronidazole.
6 ADVERSE REACTIONS Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of mebendazole was evaluated in 6276 subjects who participated in 39 clinical trials for treatment of single or mixed parasitic infections of the gastrointestinal tract. In these trials, the formulations, dosages and duration of mebendazole treatment varied. Adverse reactions reported in mebendazole-treated subjects from the 39 clinical trials are shown in Table 2 below. Table 2: Adverse Reactions Reported in Mebendazole-treated Subjects from 39 Clinical Trials * Adverse Reaction(s) Gastrointestinal Disorders Anorexia Abdominal Pain Diarrhea Flatulence Nausea Vomiting Skin and Subcutaneous Tissue Disorders Rash *Includes mebendazole formulations, dosages and treatment duration other than EMVERM ® 100 mg tablet 6.2 Postmarketing Experience The following adverse reactions have been identified in adult and pediatric patients postmarketing with mebendazole formulations and dosages other than the EMVERM ® 100 mg chewable tablet. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Table 3: Adverse Reactions Identified During Postmarketing Experience with Mebendazole * Adverse Reaction(s) Blood and Lymphatic System Disorders Agranulocytosis, Neutropenia Immune System Disorders Hypersensitivity including anaphylactic reactions Nervous System Disorders Convulsions, Dizziness Hepatobiliary Disorders Hepatitis, Abnormal liver tests Renal and Urinary Disorders Glomerulonephritis Skin and Subcutaneous Tissue Disorders Toxic epidermal necrolysis, Stevens-Johnson syndrome, Exanthema, Angioedema, Urticaria, Alopecia *Includes mebendazole formulations, dosages and treatment duration other than EMVERM ® 100 mg chewable tablets