Posted on Apr 02, 2020, 2 p.m.
The US FDA is requesting that manufacturers pull all prescription and over the counter ranitidine drugs known by the brand name Zantac from the market immediately, noting contaminant issues.
The ongoing investigation has determined that levels of a contaminant in the popular heartburn medications increases over time, and when stored at higher than normal temperatures poses a risk to public health.
N-nitrosodimethylamine/NDMA is the contaminant, and it is listed by the FDA as a probable human carcinogen. The FDA has been investigating levels of this contaminant in ranitidine since mid 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 the 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 said in part. "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 have been sent to all manufacturers of the product requesting that they withdraw the product from the market immediately, and all consumers are advised to stop taking any ranitidine tablets or liquids that they have and to dispose of them properly and not to purchase any more.
Due to the recent outbreak consumers are being advised not to return the products to the location of purchase, rather follow disposal instructions in the guide/insert or follow the FDA recommendation for safe disposal which can be viewed on their website.
Those who wish to continue treating their condition should consider using another approved medication or product; the FDA recommends talking with your physician about your options for those taking prescription ranitidine before stopping taking the medication.
"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.
This announcements follow those from CVS, Walgreens and Walmart announcing this past September that they will no longer be selling Zantac and other ranitidine medication/products due to concerns that they might contain NDMA. As well as an announcement from Sanofi voluntarily recalling Zantac OTC “due to inconsistencies in preliminary test results” in October 2019.
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