Provider Alert! FDA removing all ranitidine products from the marketTexas Children's Health Plan
Attention: All Providers and Pharmacies
Effective Date: April 2, 2020
Call to action: The FDA announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or over the counter (OTC) use in the U.S.
How this impacts providers: In response to the FDA’s request, the Vendor Drug Program (VDP) has removed all ranitidine products from the Medicaid and CHIP formularies. Formulary alternatives for histamine-2-receptor antagonists (H2RA) through the pharmacy benefits include famotidine, cimetidine, and nizatidine.
Next steps for providers: Providers should consider alternative treatments for patients receiving ranitidine containing products in both outpatient and inpatient settings.
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