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Manufacturers and Pharmacies Issue Voluntary Recall of Popular Heartburn Medication

In September, the FDA detected low levels of N-nitrosodimethylamine (NDMA) in a heartburn medication called ranitidine (Zantac). NDMA is an environmental contaminant found in water and certain foods, and, according to the FDA, it is a probable human carcinogen.

So far, the FDA has not pulled the drug from the market. Some manufacturers and pharmacies, however, are issuing voluntary recalls and suspending sales of the drug until further notice. The agency began testing the drug because of an alert from Valisure, an online pharmacy that found “extremely high levels” of the carcinogen in its own tests of ranitidine.

Why the Stark Difference in Results?

The FDA attributes the alarming results from Valisure’s testing to the fact that the pharmacy applied high heat (rather than normal body temperature) to the drug. The FDA’s preliminary testing detected much lower levels of NDMA after simulating the same conditions the drug would experience within the human body.

Although the FDA’s tests did not produce the same extreme results found by Valisure, the agency has asked all ranitidine manufacturers to test their products at a temperature close to that of the human body. The manufacturers must also test any drugs belonging to the H2 blockers and proton-pump inhibitors classes. For now, companies have not discovered NDMA in Pepcid, Tagemet, Nexium, Prevacid, Prilosec, or any other related drug.

What to Do in the Meantime

Although the FDA has not instructed consumers and patients to stop taking Zantac, the tests’ final results are still pending. While we wait for a verdict, Americans who use this drug should consider speaking with their physician. Many take it to treat heartburn, and the author of an article about the recall on the Harvard Health Blog suggests a change in lifestyle or diet to mitigate the symptoms that ranitidine treats.

Furthermore, healthcare professionals typically prescribe ranitidine for short-term use, so if you have been taking this for a long period of time, you may consider speaking with your doctor about an alternative. Even if ranitidine does contain significant amounts of NDMA, the FDA explains that it will only pose a serious health risk after extended exposure to high doses.

Did You Sustain an Injury or Illness After Using a Recalled Product?

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