Regulatory Guidance

FDA says ranitidine no more dangerous than ‘smoked meats’

Nov 05, 2019

Since all the hoopla surrounding ranitidine began, the FDA has been cautious in giving a final word on how dangerous the levels of NDMA in the drug could be.

Last week, CDER Director Janet Woodcock told a Congressional panel that the agency was still working to determine if ranitidine, which has been found to contain unacceptable levels of NDMA, is safe for consumers. But just a few days later, the agency released a statement on its testing results so far and concluded that the levels of NDMA a patient would be exposed to from taking ranitidine are no higher than one would have from eating “grilled or smoked meats.”

NDMA, which is considered a probable carcinogen, was first detected in ranitidine products by an online pharmacy. Since the discovery, the drug has been pulled from the shelves of every major American retailer, banned in some countries, and voluntarily recalled by a host of drugmakers.

Despite the scare, the FDA’s new tone seems geared toward restoring consumer confidence in the popular heartburn medicine.

“We also conducted tests that simulate what happens to ranitidine after it has been exposed to acid in the stomach with a normal diet and results of these tests indicate that NDMA is not formed through this process. Similarly, if ranitidine is exposed to a simulated small intestine environment, NDMA is not formed,” the agency said.

The FDA also said that although its tests have found lower levels of NDMA than third-party tests, the agency still finds some of the levels too high, and has asked manufacturers to continue its own testing of the products.

Read the full press release.