Contamination In Common OTC Antacid Adds To FDA’s API Impurity Concerns
Contamination In Common OTC Antacid Adds To FDA’s API Impurity Concerns
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The US Food and Drug Administration is considering how to respond after a contaminant was found in drugs containing, ranitidine, the active ingredient in Sanofi’s Zantac OTC heartburn remedy and multiple generic equivalents. HBW also looks at similar investigations in Europe
Author: Informa Pharma Intelligence
Publisher: HBW
- Description
The FDA’s Center for Drug Evaluation says it found low levels of NDMA, a probable human carcinogen in ranitidine medicines, including some OTC Zantac brand products. NDMA is dangerous when consumed in large quantities, but the FDA says the levels found in H2 blockers don’t pose a risk. This HBW story looks at similar probes by the European Medicines Authority, NDMA levels in other drugs, and statements by the FDA that while there is no recall in place, consumers should consider alternatives as multiple drugs are approved for the same or similar use.
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