Earlier this week, CVS, Rite Aid, and Walgreen’s suspended sales of Zantac (ranitidine) products. This follows the announcement last month by Sandoz, the generics division of Novartis, that it was voluntarily recalling all lots of its 150 mg and 300 mg ranitidine hydrochloride capsules “because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.” NDMA is a suspected carcinogen.
Originally approved in 1981, Zantac (ranitidine) has had an excellent track record as both a safe and effective medicine. Worldwide, Zantac’s active ingredient, ranitidine, has been used by hundreds of millions of people with heartburn, acid reflux, and gastric and duodenal ulcer symptoms.
Ranitidine is even on the World Health Organization’s List of Essential Medicines, as one of 433 drugs deemed essential for addressing the most important public health needs globally.
A similar nitrosamine impurity, N-Methylnitrosobutyric acid (NMBA), was found last year in several angiotensin II receptor blockers flagged by the FDA. Last week, a recall of the blood pressure drug losartan was expanded for the fifth time after Torrent Pharmaceuticals found a similar nitrosamine impurity in more batches of the drug.
The FDA describes NDMA as a “known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.” The agency says it’s evaluating whether the low levels of NDMA in ranitidine pose a real risk to patients and that it will post that information when it’s available.
It appears the pharmaceutical industry and FDA are following last year’s playbook when it was determined that a number of blood pressure drugs contained a similar impurity.
The FDA’s statements, voluntary recall actions by manufacturers, and suspension of sales by major drugstores suggest stakeholders are taking this matter very seriously. Online pharmacy Valisure went so far as to declare “there is no acceptable cancer risk for a drug like this.”
However, the flurry of announcements and actions regarding ranitidine products raises more questions than it answers. What is known about the relative risks associated with NDMA, whether found in water, food, or pharmaceutical products, such as Zantac? Given that on September 13th the FDA stated that the amount of NDMA found in ranitidine products “barely exceeds amounts you would expect to find in common foods,” it appears the relative risk related to ranitidine use is small.
Adding to the confusion is a seemingly unclear message being disseminated by the FDA. While the FDA has said that patients who wish to stop using ranitidine should discuss treatment alternatives with their healthcare provider, the agency is not recommending users stop taking the drug. This of course begs the question where patients will find ranitidine once their current supplies run out.