Drugmaker Novartis’ Sandoz division is halting the distribution of generic Zantac, or ranitidine, while the drug is investigated for N-nitrosodimethylamine (NDMA), a probable human carcinogen.
The FDA first announced that it had identified low levels of NDMA in some batches of Zantac and similar heartburn drugs Sept. 13. Though Center for Drug Evaluation and Research Director Janet Woodcock, MD, assured the public the amounts of NDMA in the drugs “barely exceed the amounts you might expect to find in common foods,” within a week Novartis had pulled the product from distribution.
“A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification,” the company said in a statement, per the Wall Street Journal. “This includes capsules in the U.S.A. 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.”
The Journal also reported that the European Medicines Agency is reviewing ranitidine medications for traces of NDMA, and Health Canada announced this week that companies marketing ranitidine in the country had stopped distribution until further notice.
The FDA hasn’t issued a recall of any lots of ranitidine and didn’t recommend anyone stop taking the medication, but in her initial letter Woodcock said those who are concerned can opt for another over-the-counter heartburn drug they feel more comfortable with. For patients taking ranitidine as a prescription medication, the FDA suggested they meet with their physicians to discuss alternatives.