FDA calls for heartburn drug Zantac to be pulled due to carcinogen concerns

pharmafile | April 2, 2020 | News story | Business Services FDA, NDMA, Sanofi, heartburn 

The FDA is requesting that manufactures remove Zantac (ranitidine) from the market due to risks of it containing a carcinogen.

An ongoing investigation has determined that levels of contaminant in the heartburn medications increase over time and when stored at higher than normal temperatures and it poses a significant health risk. This contaminant is N-nitrosodimethylamine (NDMA) which a carcinogen that the FDA has been investigating in ranitidine since 2019.

The FDA are now sending out letters to all manufacturers of ranitidine requesting they withdraw the products and are advising consumers to stop taking any tablets or liquid medications containing this substance. It also advised them to dispose of the drugs and not buy any more. Due to the COVID-19 coronavirus pandemic, they also recommend not to return the medicines.  

Dr Janet Woodcock, the Director of the FDA’s Center for Drug Evaluation and Research, commented on the situation and said: “We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.

“The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”

For patients taking prescription ranitidine, the FDA said they should speak to their doctor before stopping taking the medication.

Back in September, Walmart, Walgreens and CVS Pharmacy pulled over the counter ranitidine medications and Zantac from their stores due to concerns they might contain NDMA. In October, Sanofi recalled its Zantac that was sold in the US and Canada.

Conor Kavanagh

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