download (3)

FDA finds low levels of cancer-linked impurity in common heartburn drugs

The US Food and Drug Administration said Friday it has learned some ranitidine — acid-reducing and heartburn medicines, including those known by the brand name Zantac — contain low levels of an impurity that could cause cancer.

The nitrosamine impurity known as N-nitrosodimethylamine or NDMA has been classified as a probable human carcinogen based on lab tests, and this isn’t the first time that it has been detected in a common medication.

Since last year, the FDA has been investigating NDMA and other impurities in blood pressure and heart failure medicines known as angiotensin receptor blockers or ARBs. Numerous recalls have been launched as the FDA found “unacceptable levels” of nitrosamines in several of those common drugs containing valsartan.

A study published last year in the medical journal BMJ found no “markedly increased short term overall risk of cancer” among users of the valsartan drugs contaminated with NDMA. Yet that study also noted that research into long-term cancer risk is needed.

Now, with NDMA being found in samples of ranitidine, “we are still investigating all ranitidine products and we are continuing to test additional samples,” FDA spokesman Jeremy Kahn said in an email Friday.

“At this time there are no company recalls and FDA is not urging companies to recall. So far, NDMA has been found in ranitidine in low levels and we are not calling for consumers and patients to stop taking ranitidine at this time,” he said. “We do not have any information to share on how many companies’ products could be affected. The FDA will share more information with the public and industry as we learn more throughout the investigation.”

learn more about: FDA finds low levels of cancer-linked impurity in common heartburn drugs

Leave a Reply

Your email address will not be published. Required fields are marked *