Regulatory Guidance

FDA determines toxicity levels in ranitidine ‘unacceptable’

Oct 02, 2019

The FDA has changed its story on whether or not the levels of a possible carcinogen in ranitidine are too high.

When news first broke weeks ago than an online pharmacy had found traces of N-nitrosodimethylamine (NDMA) in several versions of the popular heartburn medication, the FDA cautioned that the levels detected were low. But now, the agency has issued a statement saying that early testing has confirmed unacceptable levels of NDMA in ranitidine samples.

Despite its findings, the agency also said that the testing method used by a “third-party laboratory” used higher temperatures that could have generated higher levels of NDMA.

“FDA published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities. That method is not suitable for testing ranitidine because heating the sample generates NDMA,” the agency said in a statement. 

Instead, the FDA has issued guidance on testing ranitidine, saying that manufacturers should use an LC-HRMS protocol that does not use elevated temperatures, or send samples to the agency for testing.

Although the FDA has not issued an official recall of ranitidine products, the fallout from the NDMA findings have been swift. This week, several major retailers including Walgreens, CVS, Hy-Vee and now Walmart have pulled ranitidine products from their shelves. Several manufacturers have voluntarily recalled their ranitidine products, including Sandoz. And Bangladesh has also banned the sale of ranitidine products as global regulators continue their investigation.

Read the full FDA update.

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