2020 has not been kind to Sanofi’s flagship heartburn medication Zantac. When reports first surfaced of contamination of the medication with a known carcinogen, attention immediately turned to the labs that made ranitidine, the active ingredient in Zantac. It wasn’t until researchers discovered that Zantac could be producing the carcinogen itself that calls began for a recall of the drug. The mechanism that could lead to such an occurrence, however, has not been explained to the public all that well. Today’s post will try to shed some light on the topic.
What is Zantac? If you’ve ever complained to your doctor or pharmacist about frequent heartburn, odds are that you already know the answer to this question. Zantac is an incredibly popular heartburn medication manufactured and marketed by Sanofi, a French pharmaceutical company. Zantac is available as a prescription as well as over the counter (without a prescription).
What is ranitidine? Ranitidine is the active ingredient in Zantac. It is also a key ingredient in a number of other heartburn relief medications as its primary function is that of an acid reducer.
What is NDMA? NDMA is the abbreviation for N-Nitrosodimethylamine. NDMA is classified as a probable human carcinogen, which means that it is believed to cause cancer in human beings. It was once created intentionally and used in a variety of applications from rocket fuel to sealants. However, it is now only created as the byproduct and consequence of chemical reactions – mostly in nature – and is monitored in food and water supplies. Limits on the amount of NDMA that can be present in food and water supplies are generally set very low.
What does NDMA have to with Zantac? When NDMA contamination of Zantac was first discovered, attention was focused on the labs that made ranitidine and whether failures within those labs led to the contamination. However, based on research and testing, it is now believed that ranitidine itself can break down and create NDMA when exposed to high temperatures, including temperatures reachable while in shipping, storage, and even transport in customers’ vehicles. It is also believed that standard ambient temperatures in people’s homes, such as those found in a medicine cabinet, can also lead to the creation of NDMA, albeit at a slower rate.
So, that’s why Zantac has been recalled? Yes. Because the source of NDMA contamination can be the drug itself, Zantac and all other ranitidine-based medications have been pulled from shelves until the issue can be addressed. Patients taking over-the-counter Zantac or ranitidine are advised to stop taking the medication, and those taking prescription Zantac or ranitidine are encouraged to contact their doctor about finding a suitable replacement.