FDA calls for heartburn drug Zantac to be pulled from market immediately
01 Avril, 2020, 23:45 | Auteur: Yves Courtet
U.S. health regulators are telling drugmakers to immediately pull their popular heartburn drugs off the market after determining that a contamination issue with the medications poses a greater risk than previously thought. Consumers who have the drug are being advised to stop taking it. Last year, the agency learned an independent laboratory found it in ranitidine.
The FDA said it had determined that NDMA in some ranitidine products increases over time and when stored at higher than room temperatures, resulting in consumer exposure to unacceptable levels of the impurity.
When sustained at higher levels of exposure it can increase the risk of cancer in humans.
Ranitidine products will not be available for prescription or over-the-counter use in the USA for the foreseeable future while the investigation continues. Early FDA testing showed low levels of NDMA in ranitidine and recent testing confirmed that the levels of the impurity increase in the drug over time, even under normal storage conditions. And, the longer the product is stored the level "greater the level of NDMA".
Patients on OTC ranitidine medications should stop taking any tablets or liquids they now have, dispose of them properly, and should not buy more, according to the FDA statement.
FDA Requests Removal of All Ranitidine Products (Zantac) from the Market [news release].
Patients taking prescription ranitidine should speak with their health care providers.
Due to the coronavirus pandemic, the FDA said don't return your medicines to a "drug take-back location", but rather follow disposal instructions in the medication guide or insert - or follow the FDA's recommended safe disposal steps on its website. The drugs are widely used to treat stomach acid and ulcers. According to the FDA, other drugs such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec) are acceptable medications to treat heartburn that do not contain NDMA.
Manufacturers have been told to immediately withdraw their products from the market.
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