NDMA Identified in OTC and Prescription Ranitidine

October 2, 2019 – The U.S. FDA has become aware that some products containing ranitidine, the active ingredient in Zantac®, contain low levels of N-itrosodimethylamine (NDMA), a probable human carcinogen (cancer-causing agent). NDMA is a known environmental contaminant found in water and food such as meats, dairy products, and vegetables. It is also one of the nitrosamine impurities responsible for a series of angiotensin II receptor blocker (ARB) or "sartan" medication recalls throughout much of 2018.

Ranitidine is an active ingredient in both over-the-counter (OTC) and prescription drugs. An H2 (histamine-2) blocker, it decreases the amount of acid created by the stomach. Over-the-counter ranitidine is used to prevent and relieve heartburn associated with acid ingestion and sour stomach, while prescription ranitidine is approved for indications that include the treatment and prevention of ulcers in the stomach and intestines, as well as the treatment of gastroesophageal reflux disease (GERD).

At this time, the FDA does not believe it is necessary for patients to discontinue using ranitidine products. The agency recommends that any patients who may wish to stop taking a ranitidine product speak to a healthcare professional about other treatment options and the best way to dispose of any unused product. Individuals who use OTC ranitidine and wish to stop should consider other available OTC options. A number of medications currently on the market are approved for the same or similar indications as OTC and prescription ranitidine.

Novartis has voluntarily recalled its 150mg and 300mg ranitidine hydrochloride capsules (full details are available here), while Apotex has recalled its 75mg and 150mg ranitidine tablets (details available here). Manufacturers Dr. Reddy’s and GlaxoSmithKline have halted worldwide distribution of their ranitidine-containing products. Other manufacturers – including Sanofi, the maker of brand name Zantac – have taken a more conservative approach and continue to distribute their ranitidine products while working with regulators. However, retailers such as CVS, Walgreens, and Rite Aid have elected to pull Zantac and its generics from store shelves.

The FDA is currently working with international regulators and industry partners to determine the source the NDMA impurity in ranitidine and evaluating any possible risk to patients. Any adverse events that may be tied to ranitidine use should be reported to the FDA’s MedWatch program. The agency has established a page on its website to provide the latest updates on NDMA and ranitidine.

Benecard Central Fill has not dispensed any of the currently recalled ranitidine products.