Carcinogen fears halt distribution of Zantac generics
Drugmakers and global public-health regulators are taking steps to remove supplies of a popular heartburn medication that is suspected of being tainted with a cancercausing agent from the market.
Novartis AG’s Sandoz unit said Wednesday that it was halting worldwide distribution of generic versions of the stomach drug Zantac, just days after regulators in the U.S. and Europe began investigating the discovery of a likely human carcinogen called NDMA, or N-Nitrosodimethylamine, in the medications.
Some versions of Zantac, which is also known by the generic name ranitidine, have also been recalled in Europe and Canada as well.
The U.S. Food and Drug Administration didn’t recommend people who take Zantac or its generics stop taking it but advised that other medications are available.
The moves are the latest in a series of actions aimed at getting drugs tainted with potentially deadly contaminants off pharmacy shelves. Since last year, the FDA has been overseeing a recall of a type of generic blood-pressure pills that originated in China and India and were contaminated with NDMA.
Until last week, concerns had mostly been limited to that class of hypertension drugs, known as angiotensin II receptor blockers. But Friday, the FDA and Europe’s top drug regulator said they were examining NDMA levels in Zantac and its generic forms and whether they pose any risk to patients.
Ranitidine is taken by millions of people worldwide to treat gastrointestinal disorders and discomfort. Sandoz is one of several makers of generic drugs that distribute it. French drugmaker Sanofi makes branded Zantac sold without a prescription.
“A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification, this includes capsules in the USA,” said Eric Althoff, a spokesman for Novartis. “Our internal investigation is ongoing to determine further details.”
Sandoz is also recalling its prescription oral version of ranitidine after testing found it contained NDMA levels “above what is considered acceptable,” Health Canada said in a statement Tuesday. The company didn’t disclose any details concerning the levels of NDMA that may have been found in its drugs.
Some countries in the European Union are recalling ranitidine containing an active ingredient made by an Indiabased manufacturer, Saraca Laboratories Ltd., Germany’s Federal Institute for Drugs and Medical Devices said in a statement. German health officials didn’t specify which countries are recalling the products or which drugmakers purchased the ingredients from Saraca.
There are indications other drug manufacturers could be affected by the contamination as well, according to the statement.
Saraca Labs is registered with the FDA to make active ingredients for medicines taken by American consumers. Since pharmaceutical companies don’t have to disclose where they buy drug materials, it’s unclear whether any use the company as their active ingredient supplier for Zantac or its generics sold in the U.S.
The FDA didn’t immediately respond to a request for comment about Saraca.
Health officials in Canada have asked all companies that make brand-name and generic versions of Zantac to stop distribution of the heartburn treatment in that country. The request means existing stocks of ranitidine products in pharmacies or at retail stores may continue to be sold.
Sanofi isn’t halting distribution of the drug or any of its other ranitidine products outside of Canada, Ashleigh Koss, a spokeswoman for the company said.