CVS, Rite Aid and Walgreens are pulling from their shelves the heartburn medication Zantac and its generic equivalents after the Food and Drug Administration (FDA) reported finding the medication contaminated with a probable human carcinogen known as nitrosodimethylamine (NDMA).
CVS was the first U.S. retail store to pull all ranitidine products, followed by Walgreens and Rite Aid. Regulators outside the U.S. have either restricted distribution of the drugs or removed them from their markets altogether.
GlaxoSmithKline, makers of the brand-name Zantac, and generic manufacturers Sandoz, Dr. Reddy’s Laboratories and Apotex announced they were recalling their ranitidine products from the U.S. market.
The FDA alerted the public on Sept. 13 that NDMA had been found in ranitidine, and that the impurity could have been produced during the manufacturing of the drug. At the time, the FDA did not point to a particular manufacturer’s ranitidine, and it didn’t call for a recall of the acid reducer, which is available both over-the-counter and by prescription. Instead, the agency advised consumers to stop using the medication and consider other options. Those on prescription ranitidine products should consult with their doctors.
The impurity was detected in ranitidine drugs sold by online pharmacy Valisure. A citizen petition has been filed urging the FDA to recall the medications and create acceptable standards and tests for NDMA before manufacturers are allowed to return the heartburn medications to the market.
Last year, NDMA was found in at least three high blood pressure and heartburn drugs from a class of drugs known as angiotensin receptor blockers, or ARBs. Despite numerous recalls and public concern, the FDA downplayed the potential risk of cancer despite information that suggested the impurity may have been in some medications for up to four years.
Beasley Allen attorney Frank Woodson is actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, bladder or pancreas. If you or a loved one may have been affected, please contact us.