The FDA recently released several safety alerts on ranitidine formulations, including the brand-name drug Zantac, which were found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests and animal studies. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. This contaminant is similar to what was recently found in losartan, an angiotensin II receptor blocker used to treat hypertension, that was recalled by the FDA.
The FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential effect on patients who have been taking ranitidine.
With the voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc., as well as the voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp, your patients might be asking a lot of questions about whether to continue to using their medicines and what alternatives are available.
Talking to your patients
The FDA safety alerts have been covered by various media outlets since early September. This may cause your patients to question whether they should stay on or start using ranitidine products. When discussing the recall with your patients, let them know that:
• Ranitidine is an H2 blocker (antihistamine) – available OTC and in prescription strength – used to prevent and relieve heartburn associated with acid indigestion and sour stomach. It reduces stomach acid and works longer but not as quickly as antacids.
• Not all ranitidine medicines marketed in the United States are being recalled and the FDA is not recommending individuals stop taking all ranitidine medicines at this time.
• It might be prudent to hold off taking Zantac until a final FDA conclusion is released.
• Multiple drugs are approved for the same or similar uses as ranitidine. Other treatment options are available, both prescription and OTC, for patients who are concerned about ranitidine.
• Life-style modifications may reduce or eliminate the need for heartburn drugs for long-term use. These may include weight loss, avoiding tobacco, or a change in eating patterns. Share AGA’s patient education content on gastroesophageal reflux disease (GERD) for more tips for your patients.