April 15, 2020
Effective April 1, 2020, the U.S. Food and Drug Administration (FDA) has asked all manufacturers of ranitidine containing products to remove the drugs from the U.S. market. Ranitidine, best known as the active pharmaceutical ingredient in Sanofi’s Zantac®, is available both over the counter (OTC) and as a prescription medication. It is used to treat ailments such as heartburn, gastroesophageal reflux disease, and gastrointestinal ulcers.
The FDA’s withdrawal request comes after the agency determined that N-nitrosodimethylamine (NDMA), a probable human carcinogen (cancer-causing substance), can build up in ranitidine over time. Concerns over NDMA levels in ranitidine products first arose in the summer of 2019. Manufacturers responded by recalling products with levels above the FDA’s interim limits, while certain stores stopped carrying over-the-counter (OTC) ranitidine medications. Although the degree of contamination was initially believed to be low in most recalled products, further study has shown that NDMA content increases over time in ranitidine. This means that a product can test as being within acceptable limits, only for NDMA to reach potentially hazardous concentrations while the medication is in transport or storage. The FDA recommends the following actions for consumers:
- Stop using and purchasing OTC ranitidine and properly dispose of any in their possession.
- If using a prescription ranitidine product, speak to a healthcare professional about other available treatment options before stopping the medication.
Multiple alternatives are available over-the-counter or by prescription, including:
- cimetidine (Tagamet® – GlaxoSmithKline)
- esomeprazole (Nexium® – AstraZeneca)
- famotidine (Pepcid® – Merck)
- lansoprazole (Prevacid® – Takeda)
- nizatidine (Axid® – Eli Lilly)
- omeprazole (Prilosec® – Procter & Gamble)
- pantoprazole (Protonix® – Pfizer)
To Communicate the Ranitidine Withdrawal, Benecard has:
1. Sent recall notification letters to members who had scripts filled at retail that contained Ranitidine
within the last 6 months. The letter instructed upon three important items:
- Recommendation to stop taking Ranitidine and to talk to their healthcare professional about
- How to submit a new prescription if using our mail order facility, Benecard Central Fill
- Listing of possible alternative over-the-counter (OTC) medications for OTC Ranitidine
- How to safely dispose of the Ranitidine medication
2. Posted an announcement about the Ranitidine withdrawal on our website for members to view.
In addition to finding information on the Ranitidine withdrawal on our website, members can also find the latest information on COVID-19. We created a specific COVID-19 updates page to keep you and your members up-to-date on the latest news as it pertains to your prescription drug benefit. Click here to view the COVID-19 updates page.
Should you have any questions on the above withdrawal, please contact your Benecard Client Relations Manager at (609) 219-0400 or via email.
To view the full withdrawal recommendation from the FDA, visit the agency’s website.