Updated April 10, 2020.
The U.S. Food and Drug Administration announced on April 1 that it is immediately pulling all prescription and over-the-counter ranitidine (brand name Zantac) drugs from the market because of an impurity issue.
Although most recalls are the result of contamination that occurs at some point during the drug production cycle, this particular impurity relates to the composition of the drug itself.
The FDA first noted in a statement published September 13, 2019 that some ranitidine may contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA). According to the FDA, NDMA is classified as a probable human carcinogen.
Last fall, the FDA was still investigating whether the levels of NDMA in the products were harmful. Up until the announcement this month, any recalls were done on a voluntary basis.
According to this month’s statement, “New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers.”
The FDA also noted that testing revealed that the older the ranitidine product, the higher the NDMA level, which may put it above the level considered safe.
Natasha Mirza, MD, director of the Penn Voice and Swallowing Center at the University of Pennsylvania in Philadelphia, said she first learned about a possible issue with ranitidine when a patient brought it up last year. She stopped prescribing the drug around that time and switched patients to alternatives, such as proton pump inhibitors or non-ranitidine H2 blockers. Dr. Mirza said the FDA could have done more to inform healthcare providers about the potential contamination.
“Withdrawal of ranitidine has been going on for a year, and I am glad they finally made this announcement to take all ranitidine products off the market,” she said.
Gaelyn Garrett, MD, senior executive director of the Vanderbilt Voice Center in Nashville, said she has switched most of her patients who were taking ranitidine to another H2 blocker. She is switching patients who may have physical findings suggesting they have tissue damage from acid, such as those with GERD, to a proton pump inhibitor, she said.
But she pointed out that because ranitidine is available by prescription and over the counter, it’s practically impossible to know which patients may be taking it.
Dr. Garrett encourages otolaryngologists to check out the FDA announcement and understand why the drug was taken off the market.
“We should all be more curious when things like this are announced, because our patients are going to want to know, and if we don’t have the right information, we’re going to be guilty of giving them the wrong information,” she said.