The U.S. Food and Drug Administration said in a statement on their website Friday that they’ve “discovered that some ranitidine medicines, including some products generally known as the brand-name drug Zantac, contain a nitrosamine impurity known as N-nitrosodimethylamine (NDMA) at low levels.”
Officials are investigating low levels of the possibly dangerous contaminant within the conventional heartburn medication and associated generic drugs.
For now, the FDA says patients can proceed taking their medications.
The agency stated it had detected a “possible” cancer-causing chemical in the medicines, which are sold as prescription and over-the-counter treatments to treat abdomen acid and ulcers.
FDA officials mentioned the amount of the impurity barely exceeds levels present in everyday foods. However, the identical chemical has been linked to dozens of remembers of prescription blood stress drugs in the past year. The FDA is still investigating that concern and last month sanctioned a manufacturing plant in India that makes some of the ingredients used within the medications.
Zantac maker Sanofi mentioned that it “takes affected person safety seriously, and we’re dedicated to working with the FDA.”
The FDA is liable for ensuring that U.S. medicines are manufactured in safe, sanitary conditions. However, regulators have struggled for years to inspect the supply chain as pharmaceutical production has spread globally.
For decades the FDA targeted its manufacturing inspections on U.S. factories. However, over time, most companies have moved their manufacturing overseas to benefit from cheaper labor and materials. At present, roughly 80% of the ingredients used in U.S. drugs are manufactured abroad, primarily in India and China, based on the Government Accountability Office.
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