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All ranitidine (Zantac®) products expected to be removed from the market

April 6, 2020 · Clinical Connection team

The Food and Drug Administration (FDA) announced on April 1, 2020 it will be requesting manufacturers remove all prescription and over-the-counter (OTC) ranitidine products, a popular histamine (H2)-blocker, from the market immediately. Ranitidine recalls initially began last fall (article published on our October 2019 blog). Upon further investigation, the FDA “determined the impurity in some ranitidine products increases over time and when stored at higher than room temperature may result in consumer exposure to unacceptable levels of this impurity.” As a result, ranitidine will no longer be available for new or existing prescriptions or OTC use in the United States.

What you need to know about these actions and recommendations

  • FDA is sending letters to all manufacturers requesting they remove their products from the market
  • If someone is taking OTC ranitidine products, they should consider stop taking the medicine, talk to their physician or pharmacist about other options available to them
  • If someone is taking prescription ranitidine, they should speak with their healthcare professional (e.g., prescriber, pharmacist) about other treatment options before stopping the medicine
  • FDA is not recommending consumers return their medicines to a drug take-back location at this time due to the COVID-19 pandemic, but should research other ways to safely dispose of any medications they are no longer taking.
  • FDA advises consumers to follow the specific disposal instructions in their Medication Guides, provided by their dispensing pharmacy, or follow the FDA’s guidance to safely dispose of medicines at home
  • To date, the FDA has not detected this same carcinogen (NDMA) in other H2-blockers and proton pump inhibitors (PPIs), which may also be available OTC and by prescription
    • H2-blockers – famotidine (Pepcid®), cimetidine (Tagamet®)
    • PPIs – omeprazole (Prilosec®), esomeprazole (Nexium®), lansoprazole (Prevacid®®).

Impact on workers’ compensation and auto no-fault
Upon review of our transactional data, considering many manufacturers began pulling their ranitidine products from pharmacy shelves last September, we expect a minimal impact on our book of business.

We will be providing impact assessments to our clients through our account managers and clinical liaisons. For those claimants who are still taking ranitidine products, we encourage claims professionals to let their claimants know they should speak to their prescriber as soon as possible to determine if they no longer require the use of the medication or if other treatment options are necessary.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Source:

  1. U.S. Food and Drug Administration (FDA). FDA News Release. FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. April 1, 2020. Available at: https://www.fda.gov/news-events/press-announcements/ .

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