On Wednesday, April 1, 2020, FDA issued a statement asking all companies to stop selling all forms of Zantac (ranitidine).
On Friday, September 13, 2019, the FDA announced that “some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.” FDA also noted in its September statement that “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”
Ranitidine is sold as an over-the-counter (OTC) and prescription drug. At the time of the original statement warning consumers of the possible carcinogen, no recall was issued. Rather, FDA advised anyone taking the OTC version of the product to consider switching to a different OTC medication approved for their condition. At that time, the Agency also stated that “patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options.”
Since the FDA’s initial statement, many companies that manufacture ranitidine products have issued voluntary recalls of their products.
Following the Agency’s initial statement last September, FDA launched an investigation into the presence of NDMA in ranitidine medications. The latest step in this investigation came last week when FDA issued a press release “requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.”
In this statement, the Agency noted that throughout its investigation into the presence of NDMA in ranitidine medications, it has determined that, when stored at temperatures higher than room temperature, in some ranitidine products the impurity increases over time, which may result in consumers being exposed to unacceptable levels of this impurity. Furthermore, the Agency’s testing confirmed that levels of NDMA increase in ranitidine even under normal storage conditions. In addition, “the testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”
With this announcement, FDA is advising consumers taking ranitidine products that are available OTC to stop taking any tablets or liquid that is left and to dispose of them properly. Patients who wish to continue treating their condition should consider the use of another approved OTC product. “Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).”
In the Agency’s statement, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research stated that “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
Are you in the process of developing an FDA-regulated drug or medical device? We can help you achieve successful interactions with FDA and avoid situations such as this by taking all precautionary measures possible. To learn more about our services and how we can help you, contact us today.
September 30, 2015
Currently, there are no regulations specifically regarding investigational tobacco products. As such, at this time they are not exempt from requirements stated in the FD&C Act. Last week, FDA...
April 14, 2022
On April 13, 2022, FDA published a new draft guidance for industry entitled “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic...
July 23, 2018
On Friday, July 13th, FDA announced the voluntary recall of several drugs containing the active ingredient valsartan. Valsartan is often used to treat serious medical conditions such as high blood...