Although federal health regulators have declined to order a Zantac recall, at least one generic drug maker has decided to stop shipping product amid concern that ranitidine-containing medications might be contaminated with a cancer-causing chemical.
On Wednesday, Novartis announced it would suspend worldwide distribution of over-the-counter generic Zantac products marketed by its Sandoz subsidiary.
“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 U.S.,” a Novartis spokesperson said in an email to FiercePharma.com. “Our internal investigation is ongoing to determine further details. In case of concerns, adequate additional measures will be implemented in alignment with relevant health authorities as required.”
Last Friday, the U.S. Food & Drug Administration (FDA) warned that N-nitrosodimethylamine (NDMA) had been detected in Zantac and other ranitidine-based heartburn medications.
The agency was informed of the contamination by Valisure, an online pharmacy that conducts tests on each batch of medication it sells. The company apparently found NDMA in every sample of Zantac and ranitidine tested, with levels in some samples exceeding 3,000,000 ng per tablet. The FDA’s permissible daily intake for NDMA is just 96 mg.
According to Valisure, the highest levels were found when Zantac was subjected to conditions that mimic digestion, suggesting the drug was reacting with itself to make NDMA.
The U.S. Environmental Protection Agency considers NDMA a probable human carcinogen, and animal studies have linked exposure to tumors of the liver, kidneys, and gastrointestinal tract.
The FDA has not ordered a Zantac recall, and insists that the risk of cancer associated with the tainted drugs is low. However, it urged consumers using over-the-counter versions to consider switching to another heartburn drug. Those taking prescription versions should not stop without talking to their doctor, as doing so could worsen their condition.
Valisure disagreed, and petitioned the FDA to order a recall “to protect the American public from further exposure to the potentially carcinogenic properties of ranitidine.”
Some European countries have recalled ranitidine products that contain active ingredient made by India-based Saraca Laboratories Ltd. Health Canada also asked all Zantac manufacturers to stop distributing their products in that country, and indicated that Sandoz was recalling it oral prescription ranitidine drugs.
Sanofi-Aventis has agreed to stop distributing name-brand Zantac in Canada. But otherwise, the company is moving forward as usual and has no plans to announce a Zantac recall.
“We are working closely with the FDA and are conducting our own robust investigations to ensure we continue to meet the highest-quality safety and manufacturing standards,” a Sanofi spokesperson told Bloomberg News.