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U.S. Department of Health and Human Services

Safety

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Helidac Therapy (bismuth subsalicylate, metronidazole tablet and tetracycline hydrochloride) capsule

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2012

 

Summary View

 

Revisions and sections changes throughout label

 

WARNINGS

Fetal Toxicity
  • 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.
 

ADVERSE REACTIONS

  • Anal Discomfort and Paresthesia added to table