November 2019 Medication Recall Update: Ranitidine

Prepared by: Andrea Winkel, PharmD, PGY-1 Pharmacy Practice Resident

Key Points

  • Not all ranitidine products have been recalled at this time. Updates on recalled ranitidine products can be found online here.
  • Patients who wish to discontinue ranitidine should talk with a healthcare provider about alternative treatment options before switching
  • The FDA is currently testing ranitidine products made by other manufacturers, and has begun testing other Histamine H2-receptor antagonists (H2RA) and proton-pump inhibitors (PPI)

Ranitidine Recall

On September 23, 2019, Sandoz Inc. issued a voluntary recall of 14 lots of prescription ranitidine capsules. Just two days later, another voluntary recall occurred for over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg) manufactured by Apotex Corp. and labeled by Walgreens, Walmart, and Rite-Aid. These recalls occurred after manufacturers found higher than acceptable amounts of a nitrosamine impurity, N-nitrosodimethylamine (NDMA). You might recall that earlier this year multiple angiotensin II receptor blockers (ARBs) were recalled due to nitrosamine impurities as well. The testing method created to look for these impurities in ARBs is not accurate with ranitidine due to the high temperatures used, so the FDA has recommended a specific type of testing (LC-HRMS testing protocol) to accurately test ranitidine samples for NDMA. As of now, testing that has been conducted by the FDA on samples of ranitidine products has shown unacceptable levels of NDMA.

The affected Sandoz Ranitidine includes the following lots:

Risk

N-Nitrosodimethylamine (NDMA) has been identified as an impurity or contaminant that has the potential to cause cancer in humans. It is commonly found as a contaminant in water, meats, dairy products, and vegetables. The EPA as well as each individual state has set acceptable limits for NDMA found in drinking water, as the risks associated with NDMA are generally attributed to much higher exposures levels. This contaminant recently made the news as its presence was discovered at higher than acceptable limits in prescription ARBs. The cancer risk estimated with this level of NDMA exposure from ARBs was 1 extra case for every 8,000 patients treated for four years at the highest dose. To help put this risk into perspective for ranitidine, the NDMA levels found in ranitidine products the FDA has tested so far have barely exceeded what you would normally find in certain foods. In the announcement released by Sandoz, they note that there have been no reported adverse events for ranitidine linked to the NDMA impurities.

Next Steps for Patients and Providers

Similar to the ARB recall, clear communication with the patient regarding the risks of NDMA contamination is vital to the patients understanding and comfort. Patients who are using non-recalled ranitidine products may continue to use these products. If a patient is using a recalled ranitidine product, they should continue taking the medication until they are able to speak with a healthcare provider (Pharmacist or Physician) to either switch to a non-recalled ranitidine product or switch to an alternative treatment option appropriate for their condition. See Table 1 and Table 2 for approved indications and additional considerations for other H2RA products and PPI products. Healthcare providers and patients should continue to follow updates released by the FDA as they continue to test different ranitidine products as well as other H2RA and PPI products. The FDA is also encouraging both healthcare providers and patients to report any adverse reactions from ranitidine. This can be done by submitting a report through the FDA’s MedWatch program website.

Table 1: Histamine H2-receptor antagonists (H2RA)

Staying Up-to-Date

References

  1. U.S Food & Drug Administration. (2019, Oct 2). Drug Safety and Availability: FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). Retrieved from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
  2. U.S Food & Drug Administration. (2019, Sep 23). Safety Recalls, Market Withdrawals, & Safety Alerts: Company announcement from Sandoz Inc. Retrieved from: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated
  3. U.S Food & Drug Administration. (2019, May 2). Drug Safety and Availability: Laboratory analysis of valsartan products. Retrieved from: https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-analysis-valsartan-products
  4. Lexicomp OnlineTM [Internet]. Hudson (OH): Lexicomp. C1978 – .Lexi-drugs online [cited 2019 Oct 4]; [about 4 screens].

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