GlaxoSmithKline, the original manufacturer of Zantac, has suspended distribution of all ranitidine products, as health regulators around the world continue to investigate the presence of a cancer-causing chemical in the popular antacids.
The company also announced it would be recalling all ranitidine-containing medications in India and Hong Kong.
Zantac and ranitidine are among the most popular heart burn drugs in the world.
The U.S. Food & Drug Administration (FDA) granted approval to GlaxoSmithKline to market prescription Zantac in 1983. About two dozen generic drug makers eventually won approval to sell ranitidine-containing medications in the United States.
Sanofi-Avantis received FDA clearance to market name-brand Zantac over-the-counter in 1995. Glaxo currently does not market any ranitidine product in this country.
Zantac and ranitidine have been at the center of controversy since September 13th, when the FDA warned that N-Nitrosodimethylamine (NDMA) was detected in samples of the medications. The U.S. Environmental Protection Agency considers NDMA a probable human carcinogen, as animal tests suggest exposure to the compound increases the risk for cancer.
The FDA characterized the amounts detected in ranitidine and Zantac as “low” and indicated it was trying to determine if the contamination posed any health risk. However, consumers using over-the-counter products were urged to consider switching to a different antacid. Those taking prescription versions were advised not to stop taking the medications without talking to a doctor, as doing so could worsen the condition being treated.
Valisure, the online pharmacy that informed the FDA of the Zantac contamination, disputes the agency’s characterization. According to the company, NDMA was detected in every sample of Zantac and ranitidine it tested and often at levels that far exceeded the daily limits established by the FDA. Valisure also asserted that the presence of NDMA resulted from the instability of the ranitidine molecule, which can degrade under the conditions created by digestion.
While the company urged the FDA to order a ranitidine recall, the agency has so far declined to do so.
Nevertheless, Novartis has since announced that it was halting distribution of all ranitidine drugs marketed by its Sandoz, Inc. subsidiary. The company also became the first drug maker to announce a ranitidine recall, after its own tests found NDMA at levels higher than the FDA limits.
Several other generic manufacturers, including Dr. Reddy’s Laboratories, LTD. and Saraca Laboratories LTD. have also decided to end ranitidine shipments for the time being.
Health Canada has ordered all drug makers to suspend shipments of Zantac and ranitidine in that country. While Sanofi-Aventis has agreed to stop distribution in Canada, the company has not done so elsewhere.
Sanofi also indicated it had no plans to announce a Zantac recall at this time.