Should FDA Suspend All Ranitidine Medications​ Over Carcinogen Concerns?

Health officials in both Europe and the United States are currently investigating the grounbreaking—and very popular—heartburn treatment, Zantac (and its generic, ranitidine), after a new investigation has determined the presence of carcinogens.  

Specifically, the new research from an online pharmacy Valisure says they found notable levels of a probable carcinogen. More importantly, this is the same contaminant that has been recently found in blood pressure pills; an event that quickly prompted a recall, last year. 

In a statement, the regulator who identified the issue said, “The FDA is evaluating whether the low levels of [the contaminant] NDMA in ranitidine pose a risk to patients.” The same regulator has also commented “The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options.”  

Ranitidine, of course, is a type of medicine used to treat stomach acidity. This medicine is most often prescribed or suggested for heartburn. Indeed, it is available in both prescription and over-the-counter formulations. 

Sanofi, the maker of Zantac, released a statement in response to the news. The pharmaceutical company said, “Sanofi takes patient safety seriously, and we are committed to working with the FDA.”  The company also goes on to note that Zantac’s over-the-counter formulation “has been around for over a decade and meets all the specified safety requirements for use in the OTC market.”

Perhaps most importantly, the FDA has commented that NDMA can be harmful with a large amount of exposure.  The preliminary tests indicate that while NDMA may be present, the levels do not appear to be much higher than what might be found in many common food items. As such, the FDA reminds there is no cause for major concern right now. Of course, more testing is underway to more concretely identify any potential health risk that may arise out of this contamination. 

But while the FDA is not making any use recommendations, the independent probe from Valisure persists that the FDA should recall and suspend all ranitidine sales. Valisure CEO David Light advises, “Every manufacturer and every type of Zantac or ranitidine that we’ve analyzed seems to have the same problem of the drug itself being very unstable and degrading, or even potentially reacting to, the condition in the human stomach to create NDMA.”