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By pharmatrax
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The Food and Drug Administration (FDA) announced this week that yet another company was issuing a recall for a generic version of the heartburn drug Zantac.
Aurobindo Pharma USA, Inc., has recalled a handful of its products that contain ranitidine, the generic version of Zantac, following in the footsteps of U.S. pharmacy giants like CVS and Walgreens as well as the drug’s maker, French company Sanofi. The recalls come after the FDA announced that Zantac was found to contain low levels of a cancer-causing chemical called nitrosodimethylamine (NDMA).
However, there are other drugs that work similarly to Zantac and are safe alternatives, including Pepcid and Tagamet
Drugs included in Aurobindo’s recall include both capsules and syrups; a full list of recalled items can be found on the FDA’s website.
Along with the recall, the company urged people who have prescribed the drugs to continue taking them until they can consult their doctors to get access to an alternative drug if need be. The company also noted that, to date, it has not received any reports of medical issues related to the drugs, but the recall comes after the FDA found that the products contained above-recommended levels of NDMA.
Ranitidine is a generic version of the popular heartburn drug Zantac, which the FDA announced in September was found to contain NDMA. Despite the fact that doctors, researchers, and the FDA itself is still trying to come to a clear consensus on just how much of the chemical is in Zantac, many major drug retailers were quick to pull the products from their shelves. CVS said in a statement that its decision to recall the drug, and its own generic version of it, was out of “an abundance of caution.”
Despite the lingering confusion regarding exactly how dangerous Zantac and its generic versions are, the FDA did advise people who use the drug to consider using a different heartburn medication. After the FDA’s initial warning in September, SurvivorNet spoke to Dr. Jamie Koufman, one of the country’s leading experts in acid reflux and heartburn, and she said heeding this advice and switching to an alternative medication or method to alleviate heartburn is probably the best bet — for right now, at least.
“In all my years treating patients, I have yet to see major side effects from Zantac,” Dr. Koufman said. “But I’m not recommending it at this time until all the data comes in [from the FDA].”
Despite the recalls and the precaution, it’s hard to determine at this point just how dangerous Zantac and the generic forms of the drug are. As Dr. Koufman stated, Zantac has been used to address heartburn symptoms for a huge number of patients for decades. Plus, the probable cancer-causing chemical in Zantac is also found in many foods, like smoked meats and fish.
So, is taking Zantac occasionally really more dangerous than indulging in the occasionally smoked pork?
If the levels of NDMA are as low as they are in smoked meat or fish, the risk for taking Zantac would essentially be the same as the risk a person takes when consuming these foods. However, the problem lies with mixed data. Doctors are still trying to figure out exactly how much NDMA is in Zantac. Data from the FDA has not matched up with data from other investigations — so the industry is still trying to come to a consensus.
Until the numbers come out, our experts tell us that trying to avoid heartburn with lifestyle changes or switching to an alternative medication is the safest bet.