The US Food and Drug Administration is requesting that manufacturers pull the over-the-counter drug known by the brand name Zantac, from the market immediately.
What We Know:
- The FDA noted that an ongoing investigation has determined that levels of a contaminant in the heartburn medications increased over time and when stored at higher-than-normal temperatures, posed a risk to public health.
- The contaminant, N-nitrosodimethylamine, 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.
- “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,” Woodcock advised. “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.”
- Letters are now being sent to all manufacturers of ranitidine requesting that they withdraw products from the market, and consumers are advised to stop taking any ranitidine tablets or liquid medications they currently have.
- Due to the coronavirus pandemic, the FDA said don’t return your medicines to a “drug take-back location,” but follow disposal instructions in the medication guide or insert or follow the FDA’s recommended.
- Consumers who wish to continue treating their conditions should consider using other approved medications. “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. The FDA has not found NDMA in some other products, such as famotidine or Pepcid, esomeprazole or Nexium, or omeprazole or Prilosec.
In October, drugmaker Sanofi voluntarily recalled Zantac OTC sold in the United States and Canada. At the time, the company stated it issued the recall “due to inconsistencies in preliminary test results”.