Medical Mutual Updates: FDA Removals & Alerts

/in , /by
FDA Requests Removal of Ranitidine (Zantac) from Marketplace Due to Potential Elevated Cancer Risk
Applies to: Individual; Small Group (1-50), 51-99, 100+, MEWA; All Medicare Business
The Food and Drug Administration (FDA) has requested the withdrawal of all forms of Ranitidine (Zantac) from the U.S. market due to a determination that the NDMA (N-Nitrosodimethylamine) in some ranitidine drug products increases to an unacceptable level over time and when stored at higher than room temperatures. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

Member Communication
Members who have recently filled a prescription for this medication will receive a letter notifying them of the FDA’s decision and recommending they talk to their doctor about alternative medications or other ways to help alleviate symptoms without medication.
 
 
FDA Issues Alert Regarding Possible EpiPen Auto-injector Malfunction and User Administration Error
Applies to: Individual; Small Group (1-50), 51-99, 100+, MEWA; All Medicare Business
The U.S. Food and Drug Administration issued a product alert regarding potential errors with Mylan EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions. These errors could either delay or prevent emergency treatment when needed.

Member Communication
A letter will be sent to members to make them aware of this issue and to provide instructions for obtaining a replacement device. There will be no cost for members or groups for replacement EpiPens.