The FDA (US Food and Drug Administration) announced on Friday Sept. 13, a warning to consumers of a drug commonly known as Zantac that was being halted from delivery to US markets due to a contamination.
A distribution halt is different from a recall which means existing stock of drugs in pharmacies or stores can still be sold.
“The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables,” the FDA said in a statement.
NBC reported that Novartis AG’s Sandoz unit said on Wednesday Sept. 18, it was halting distribution of its versions of the drug commonly known as Zantac in all its markets, including the United States and Canada, after contaminants were found in the heartburn drug.
The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.
“When the agency identifies a problem, it takes appropriate action quickly to protect patients. The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients. FDA will post that information when it is available,” said in their statement, “patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health. Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”
Health Canada said it had requested the makers of the drug to stop distribution as it gathers more information and consults with international health regulators, according to the NBC report.
Neither the U.S. Food and Drug Administration nor the European Medicines Agency had asked patients to stop taking the drug when the regulators said last week they were reviewing the safety of ranitidine.
Novartis said in an emailed statement to NBC its step was precautionary and adequate measures “will be implemented in alignment with relevant health authorities as required.”
“The agency is working with international regulators and industry partners to determine the source of this impurity in ranitidine. The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients. The FDA will take appropriate measures based on the results of the ongoing investigation. The agency will provide more information as it becomes available,” said the FDA.
Furthermore they advise that consumers and health care professionals should report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the scope of the problem:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178
PHOTO: NBC
