April 03, 2020
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FDA Recommends Discontinuation of OTC Zantac

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The FDA has requested that manufacturers withdraw all prescription and over-the-counter ranitidine drugs and advised patients to discontinue taking over-the-counter versions of the drug, according to an agency release.

This move is the most recent step in the agency’s ongoing investigation of N-Nitrosodimethylamine (NDMA) contamination in ranitidine medications, according to an agency safety alert. The FDA said it determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity.

“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”

When the FDA first warned about the potential contamination in September 2019, they did not have enough evidence to recommend that patients should stop taking the drug. However, it is now advising consumers to discontinue any tablet or liquid, over-the-counter ranitidine and to dispose of any leftover medication they may have.

The agency advised patients taking prescription ranitidine to speak with their health care provider about other treatment options before stopping the medicine. So far, ranitidine is the only H2 blocker in which NDMA has been found.

The FDA is encouraging health care professionals to report adverse events or side effects related to the use of ranitidine products.

Reference:

FDA.gov