Getting away from the COVID-19 pandemic, some readers may remember the story about the tiny little pharmacy that could. That is, lower the boom on meds’ purity levels, specifically, that of Zantac and a contaminant, NDMA. Well, looks like they were right:
The U.S. Food and Drug Administration today 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 OTC use in the U.S. [US Food and Drug Administration]
I wonder if you can return unused portions for refunds; I certainly wouldn’t ingest this product, even if you’ve carefully stored it properly, because you don’t know how it was stored post-production, pre-delivery. The FDA does recommend immediate disposal, as visiting stores or other places that accept discarded drugs is not recommended at the current time.
If this is a result of farming production out to foreign manufacturers – and that’s not addressed in the FDA letter – then, in combination with the threat to drug manufacturing posed by COVID-19, we may see a slow withdrawal of previously outsourced manufacturing back to the States, along with redevelopment of domestic sources of materials. According to this CNN article, Sanofi has been experiencing pain and >ahem< feedback over this product for a while.
I suppose it depends on how much actions like these cost the pharmas and their allied manufacturers.
