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Blog articles are provided as informational purposes only and are not intended to constitute medical advice. Medication protocols are subject to patient’s medical provider’s authorization.

 

The U.S. Food and Drug Administration (FDA) has identified that some ranitidine products, including those commonly known as the brand name drug, Zantac®, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified by U.S. government organizations, such as the Environmental Protection Agency (EPA), as a probable human carcinogen (a substance that could cause cancer).

 The FDA has determined that the NDMA impurity in these ranitidine products increases over time, and when stored at higher than room temperatures, may result in consumer exposure to unacceptable levels. As a result, on April 1, 2020, the FDA announced that it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine medications from the market immediately.

Important information to keep in mind:

  • As a result of this market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
  • The FDA is recommending that individuals who take OTC ranitidine stop taking it at this time, and that individuals who take prescription ranitidine consult with their healthcare professional about other treatment options before stopping the medicine.
  • In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location. Follow the specific disposal instructions in the medication guide or package insert, or follow the FDA’s recommended steps for disposal of unused medications. At this time, ranitidine has NOT been added to the Do Not Flush list.
  • Ranitidine is a histamine-2 (H2) antagonist used to decrease acid produced in the stomach. Multiple drugs are approved for the same or similar uses that do not carry the same risks from the NDMA impurity. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid®), cimetidine (Tagamet®), esomeprazole (Nexium®), lansoprazole (Prevacid®), or omeprazole (Prilosec®).

ProCare clinical pharmacists are available directly through option #4, 24/7, to assist with decision making for the best therapeutic alternatives for your patients.  Additionally, your Account Manager can assist with any formulary changes based on the information above. Thank you for your continued partnership.

 

Reference:

United States Food & Drug Administration, April 2020.

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