Zantac Products Should Not Be Sold or Used, F.D.A. Warns
Although most drug makers pulled the heartburn products months ago, the FDA told consumers they should throw out any over-the-counter medications they still have because of cancer risks.
The Food and Drug Administration on Wednesday asked companies to stop selling all forms of the heartburn drug Zantac, after concluding that a potential cancer-causing contaminant can build up in the drug when stored for long periods.
The agency also recommended that consumers who use over-the-counter forms of the drug, also known as ranitidine, stop taking it and that they should dispose of any tablets or liquid that they have. People who take prescription forms of the drug should speak with their doctors about other options before stopping treatment.
What is the carcinogenic contaminant?
The contaminant, N-nitrosodimethylamine or NDMA, is a probable human carcinogen and the FDA has been investigating levels of it in ranitidine since the summer of 2019.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in Wednesday’s announcement.
Since there is no way for the FDA to know how long the product might have been stored before you got it, the decided it was best to make sure it was not available to consumers and patients unless its quality can be assured. The FDA will continue efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
What to do with if you take this drug or have any at home?
For patients taking prescription ranitidine (Zantac), the FDA said to talk to your doctor about other treatment options before stopping the medicine.
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.
Are there safe alternatives
Yes! There are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA, according to the FDA. These include famotidine or Pepcid, esomeprazole or Nexium, or omeprazole or Prilosec.
If you are patient of mine, and have any questions about this, please contact the office. If you are not a patient but have questions, please contact your primary care physician or gastroenterologist who manages your condition.
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