The FDA announced on September 13, 2019, that low levels of a probable human carcinogen called N-nitrosodimethlylamine (NDMA), were found in Zantac (ranitidine).
As a result, major drugstores such as Walgreens and CVS have taken all generic versions of ranitidine and Zantac off their shelves until further notice from the FDA.
Drug manufacturers, Sandoz (a division of Novartis) and Apotex have also decided to take action and are recalling all of their generic ranitidine drugs that are sold in the United States.
The FDA is working with multiple international agencies to review the medications and to determine if the impurities pose a health risk to users.
The agency is also asking ranitidine manufacturers to perform tests on their individual products and to send samples to the FDA for additional examinations.
Step 1
Zantac was introduced in 1983, as the first member of a new class of medications, known as histamine H2-receptor antagonists (H2 blockers). It has been widely marketed as a safe treatment for heartburn, acid indigestion, sour stomach, gastroesophageal reflux disease (GERD) and other conditions.
The active ingredient in Zantac is ranitidine, which has an inherent molecular structure that may react with itself. This can produce dangerous levels of the chemical N-Nitrosodimethylamine (NDMA) when exposed to high temperatures inside the human body or during transport (such as in a hot car).
For decades, NDMA has been known to increase the risk of cancer in humans. While the drug makers knew or should have known about the link between Zantac and cancer, they failed to adequately research the risk or warn users and the medical community.
Following exposure for only a few months, experts indicate that NDMA may result in the development of cancer from Zantac.
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