FDA Finds Cancer-causing Impurity In Ranitidine

(RTTNews) - The U.S Food and Drug Administration announced that it has learned that heartburn medication ranitidine includes an impurity that could cause cancer.

FDA said some ranitidine products commonly known as the brand-name drug Zantac, contain a impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen, a substance that could cause cancer.

The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year.

"The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options," the FDA said in the statement.

Ranitidine medicines are used to treat stomach acidity and heartburn and are both over-the-counter and prescription drugs.

"Sanofi takes patient safety seriously, and we are committed to working with the FDA," Sanofi told CNBC in a written statement. The Zantac over-the-counter medication "has been around for over a decade and meets all the specified safety requirements for use in the OTC market."

The FDA said that although NDMA may cause harm in large amounts, it is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients.