Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Potential for Carcinogenicity
- Metronidazole has been shown to be carcinogenic in mice and rats. Tumors affecting the liver, lungs, mammary and lymphatic tissues have been detected in several studies of metronidazole in rats and mice, but not hamsters (see PRECAUTIONS, Carcinogenesis, Mutagenesis, Impairment of Fertility). It is unknown whether metronidazole is associated with carcinogenicity in humans.
- Skin and subcutaneous disorders including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome (drug rash with eosinophilia and systemic symptoms) have been reported. Discontinue treatment at the first evidence of a cutaneous reaction
Increased Plasma Concentrations in Patients with Hepatic Impairment
- Patients with hepatic impairment metabolize metronidazole slowly, with resultant accumulation of metronidazole in the plasma. Use HELIDAC Therapy with caution in patients with mild to moderate hepatic impairment. HELIDAC Therapy may not be appropriate for patients with severe hepatic impairment (Child-Pugh C)
Revisions and sections changes throughout label
- There are no adequate and well-controlled studies of Helidac Therapy in pregnant women. However, tetracycline can cause fetal harm when administered to a pregnant woman. The use of drugs of the tetracycline class during the second and third trimester pregnancy can also cause permanent discoloration of the teeth (yellow-gray brown) and possibly inhibit bone development. Administration of oral tetracycline to pregnant rats at various doses resulted in yellow fluorescence in teeth and bones in the newborn animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
- Anal Discomfort and Paresthesia added to table