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FDA Calls for Heartburn Drug Zantac to be Recalled Immediately

2020-04-01T21:18:32.475Z


The US Food and Drug Administration (FDA) Requests Manufacturers Recall All Prescription Ranitidine Medications Immediately ...


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(CNN) - The US Food and Drug Administration (FDA) is asking manufacturers to immediately recall all prescription and over-the-counter ranitidine medications known as the Zantac brand, the agency announced Wednesday.

READ: CVS Recalls Zantac and Similar Heartburn Medications Over Cancer Concerns

The FDA noted that an ongoing investigation found that levels of a contaminant in heartburn medications increase over time and, when stored at higher-than-normal temperatures, pose a risk to public health.

The contaminant, N-nitrosodimethylamine, or NDMA, is a probable human carcinogen and the FDA has been investigating its levels in ranitidine since the summer of 2019.

"We did not see unacceptable levels of NDMA in many of the samples we tested," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in Wednesday's announcement.

LEE: Stop distribution of ranitidine medications for heartburn (found contaminants)

"However, since we don't know how or for how long the product could have been stored, we decided that it should not be available to consumers and patients unless its quality can be guaranteed," Woodcock said. "The FDA will continue our efforts to ensure that impurities in other medications do not exceed acceptable limits so that patients can continue to take medications without concern."

According to the FDA announcement, letters are now being sent to all ranitidine manufacturers requesting that they withdraw the products from the market, and consumers are advised to stop taking the current ranitidine tablets or liquid medications. The FDA requests that they be disposed of properly and no longer be purchased.

READ: Heartburn Drugs May Cause Allergies, Study Says

Due to the coronavirus pandemic, the FDA stated that drugs should not be taken to a "drug drop-off location", but follow the disposal instructions in the medication guide or package insert, or follow the safe disposal steps recommended by the FDA on its website.

Consumers who want to continue treating their condition should consider using other approved medications, according to the FDA.

To date, the FDA has not found NDMA in other products, such as famotidine or Pepcid, esomeprazole or Nexium, or omeprazole or Prilosec.

For patients taking prescription ranitidine, the FDA said they should discuss other treatment options with their doctor before stopping 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.

In September CVS Pharmacy, Walgreens and Walmart announced that they would no longer sell Zantac and other over-the-counter ranitidine medications due to concerns that they might contain NDMA.

Then, in October, drug maker Sanofi voluntarily recalled Zantac OTC sold in the United States and Canada. At the time, the company said it issued the recall "due to inconsistencies in the preliminary test results."

Fda

Source: cnnespanol

All news articles on 2020-04-01

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