GlaxoSmithKline is conducting a worldwide Zantac recall, following confirmation from the U.S. Food & Drug Administration (FDA) that testing had detected “unacceptable levels” of a cancer-causing chemical in some ranitidine-containing drugs.
Zantac and generic versions of ranitidine are used by millions of people to treat heartburn and other conditions associated with the excess production of stomach acid.
Glaxo, the original manufacturer of Zantac, had stopped shipping ranitidine products earlier this month. The recall was announced yesterday, and affects only prescription versions of Zantac, including a syrup, an injection, and tablets in 150 and 300 mg. doses.
Name-brand Zantac is also sold over-the-count in 75 mg tablets. However, those products are marketed by Sanofi-Aventis and are not included in Glaxo’s recall.
On September 13th, the FDA warned that some samples of ranitidine and Zantac, including prescription and over-the-counter versions, had tested positive for the presence of N-nitrosodimethylamine (NDMA), a probable human carcinogen.
The tests were conducted by Valisure, an online pharmacy that has petitioned the FDA for a Zantac recall. The company indicated that NDMA was detected in every sample of Zantac and ranitidine it tested, and at levels far above the FDA’s recommended daily limits. Valisure also asserted that the presence of NDMA resulted from the instability of the ranitidine molecule, which purportedly degrades under the conditions created by digestion.
The FDA confirmed the unacceptable levels of NDMA last week, but suggested the findings were the result of high temperatures utilized by Valisure’s testing method. The agency continues to conduct its own Zantac tests and has asked drug makers to do the same, advising they use an alternative, low-temperature method. That method has also detected NDMA in Zantac and ranitidine, but at lower levels.
Valisure agreed that the higher temperatures employed by its tests likely generated high levels of NDMA. However, the company maintains that a separate analysis involving conditions similar to the human stomach generated over 300,000 nanograms of NDMA, significantly higher than the FDA’s daily limits.
Glaxo is not the only drug maker pulling back on Zantac or ranitidine because of the NDMA controversy.
Novartis also stopped distribution of ranitidine products marketed by its Sandoz, Inc. subsidiary, and later announced a worldwide recall for prescription versions. Dr. Reddy’s Laboratories and Apotex removed their ranitidine drugs from global market, while Wal-Mart, Walgreens, CVS, and Rite-Aid have pulled the medications from their store shelves.
Health Canada has asked pharmaceutical companies to suspend distribution of ranitidine pending further investigation. Meanwhile, regulators in Hong Kong and Ireland have ordered ranitidine and Zantac recalls.
Sanofi-Aventis indicated it would not be recalling Zantac for the time being. The company is already facing a number of Zantac lawsuits in courts around the United States, including personal injury claims for cancer and class action complaints that seek medical monitoring for consumers who ingested allegedly tainted drugs.