Drugmakers and global public-health regulators are taking steps to remove supplies of a popular heartburn medication that may have become tainted with a cancer-causing 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 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 U.S. Food and Drug administration has been overseeing a recall of a type of generic blood-pressure pills, Valsartan, 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 on 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 generic-drug makers that distribute it. French drugmaker Sanofi makes branded Zantac sold without a prescription.
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.
Some countries in the European Union are recalling ranitidine containing an active ingredient made by an India-based 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 what 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.
Online pharmacy Valisure, which tests all the drugs it distributes, detected the NDMA levels in Zantac and its generics and petitioned the FDA to recall the drugs.
NDMA may be inherent in the ranitidine molecule, said Valisure Chief Executive David Light.
