Zantac®/Ranitidine Update

FDA announcement 9/13/2019

“FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, 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. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

As of Tuesday, October 2, 2019 the FDA still has not issued a recall of either Zantac or Ranitidine. However, the following manufacturers have issued voluntary recalls of their products:

Apotek Corporation: Both 75 and 150 mg over the counter medication sold primarily as house brands at Rite Aid, Walmart and Walgreens. If you have any questions, please follow this link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and#recall-announcement

Sandoz Corporation: Has issues a voluntary recall of Ranitidine Hydrochloride Capsules 150 and 300 mg. More information may be found by following this link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated#recall-announcement

At this time, we are recommending to our patients who need to use either Zantac or the generic Ranitidine to switch to Pepcid 20 mg or generic Famotidine 20 mg. If you are taking 150 mg of Zantac/Ranitidine you may then take 20 mg of Pepcid/Famotidine. If you are taking two (2) 150 mg Zantac/Ranitidine then you should take two (2) of the Pepcid/Famotidine 20 mg tablets.

If you are worried about drug interactions between medication that you are currently on and Pepcid, follow this link to the WebMD® Drug Interaction Checker: https://www.webmd.com/interaction-checker/default.htm.  If you find anything of concern, please call our office to make an appointment with one of our healthcare providers.

As more information becomes available we will post this information on the website. If you need to make an appointment to discuss this with one of our healthcare providers, please call 216-593-7700, option 3 to make an appointment.

Jack Lissauer, MD

Michael Frankel, MD

Trisha Doran, MD

Peter Greenwalt, MD