Tests conducted on samples of Pepcid, Tagamet, Nexium and other Zantac alternatives found no trace of the cancer-causing chemical that’s led to ranitidine recalls and sales suspensions around the world.
The U.S. Food & Drug Administration (FDA) began testing heartburn drugs last month, after traces of N-nitrosodimethylamine (NDMA) were discovered in samples of Zantac and generic ranitidine products.
NDMA is classified as a probable human carcinogen by the U.S. Environmental Protection Agency. Animal testing suggests exposure to the nitrosamine compound can increase the risk for cancer, especially tumors of the liver, kidneys, and gastrointestinal tract.
The FDA issued an initial Zantac warning on September 13th, after the online pharmacy Valisure informed the agency that it had detected NDMA in every sample of Zantac and ranitidine tested, including over-the-counter and prescription versions. In some cases, the levels detected far exceeded the FDA’s daily limits for NDMA.
The FDA advised consumers using over-the-counter products to consider switching to one of many Zantac alternatives. Those taking prescription versions of ranitidine should speak with their doctor before they stop treatment, as doing so could worsen their condition.
The FDA also asked Zantac and ranitidine manufacturers to conduct their own testing, and requested that they submit samples for testing by the agency. While the agency acknowledged that some of those samples tested positive for “unacceptable” levels of NDMA, it suggested the findings resulted from a high-temperature testing method employed by Valisure. However, the low-temperature tests favored by the FDA have also detected NDMA in Zantac and ranitidine, although at lower levels.
Valisure continues to stand by its findings, pointing out that a separate analysis suggested the presence of NDMA resulted from the ranitidine molecule’s instability, which degrades when subjected to the conditions created by digestion.
While the FDA hasn’t ordered a Zantac or ranitidine recall, several drug makers have chosen to pull their products from the market, including GlaxoSmithKline, Dr. Reddy’s Laboratories, and Sandoz. Late last week, Sanofi-Aventis recalled all name-brand Zantac products sold over-the-counter in the United States and Canada.
Various retailers, including CVS, Walgreens, and Rite-Aid, have removed all Zantac and ranitidine drugs from store shelves.