Ranitidine (Zantac) recall expanded, many questions remain

As anticipated, recall of the popular heartburn medicine ranitidine (Zantac) has expanded. But we still have more questions than answers.
As I mentioned in my original blog post on this topic, the online pharmacy Valisure, which originally alerted the FDA to the issue, found what they called “extremely high levels” of the probable cancer-causing substance N-nitrosodimethylamine (NDMA) in ranitidine products.
The FDA has indicated that its own preliminary testing has detected low levels of NDMA in ranitidine.
Testing methods may have influenced NMDA results
The FDA has clarified that the testing method that found the “extremely high levels” of NDMA applied high heat, at a level much higher than normal body temperature. In other words, the testing did not reflect typical conditions under which the medication would be stored or taken.
The FDA is asking all companies that manufacture ranitidine, as well as other similar medications (both H2 blockers, the class of drugs to which ranitidine belongs, and proton-pump inhibitors, or PPIs, a different class of drugs used for similar conditions), to test their products using lower heat closer to normal body temperature. So far, there is no indication that these other products are affected; the FDA is likely asking for these tests only as a precaution.
As of now, the FDA has allowed ranitidine to remain on the market. Still, some manufacturers have issued voluntary recalls and some pharmacies have pulled it off the shelves.
FDA ...

Source: Harvard Health Blog - October 10, 2019 Category: Consumer Health News Authors: Joshua Gagne, PharmD, ScD Tags: Digestive Disorders Drugs and Supplements Source Type: blogs