What is NDMA in Zantac?

N-nitrosodimethylamine, commonly abbreviated as NDMA, is a probable human carcinogen found in Zantac, generic ranitidine products, and other common medications used to treat heartburn and other disorders. Ranitidine products include many generic and over the counter (OTC) versions of Zantac. Heartburn medications that are part of the ranitidine drugs are subject to the United States Food and Drug Administration (FDA) voluntary recall notice issued on April 1, 2020. The good news is that the FDA has not found high levels of NDMA in Proton Pump Inhibitor medications such as cimetidine (Tagamet), lansoprazole (Prevacid), esomeprazole (Nexium), or omeprazole (Prilosec). The recall of Zantac and all ranitidine products has affected nearly 15 million Americans. However, long-term use of Proton Pump Inhibitor medication has links to other devastating health concerns.

Low levels of NDMA are also present in common foods such as meat and dairy products. The problem with NDMA in ranitidine products is that it can increase over time and when exposed to high temperatures. This moves NDMA into the category of probable human carcinogen, which means that people who take high levels of NDMA or take moderate amounts for a long time could have an increased risk of developing cancer.

How Did the FDA Discover High Levels of NDMA in Ranitidine Products?

The FDA considers consuming up to 96 milligrams of NDMA per day an acceptable risk. Time and temperature are the two biggest factors that can increase the NDMA present in ranitidine products to unacceptable levels. When the FDA studied levels of NDMA in ranitidine products, it found evidence of NDMA in the active pharmaceutical ingredients (API) and the finished ranitidine products.

Scientists at the FDA then simulated gastric and intestinal fluids to study the side effects of NDMA. The FDA team discovered that NDMA did not form in the stomach or intestines. However, the FDA team did discover that the levels of NDMA in some ranitidine medicines increased at room temperature due only to the passage of time. Warmer than usual temperatures also caused levels of NDMA to increase to potentially unsafe levels and meet the definition of a probable human carcinogen.

Since the FDA approved Zantac and ranitidine products to treat heartburn and related health conditions in 1984, many people wonder why it took until 2019 to discover the potentially deadly effects of NDMA. This is certainly a legitimate question. The official explanation by the FDA is that it continually evaluates and acquires new knowledge about drugs and that testing methods have become more sophisticated over time.

Although the FDA nor drugmakers were aware of the potential link between high levels of NDMA and human cancer until the fall of 2019, you or someone you love could have developed symptoms long before that. The FDA has received citizen petitions from Emery Pharma and Valisure regarding the presence of nitrosamines in ranitidine products. The government organization has publicly printed three official responses to the citizen petitions thus far in 2020. Unfortunately, these responses do not go nearly far enough for those suffering from cancer or who have lost a loved one to cancer linked to Zantac products.

What Should You Do if You Have Ranitidine Medicines in Your Home?

Zantac and all ranitidine medicines have not been available by prescription or as an OTC medication for nearly six months due to the FDA recall. If you still have prescription ranitidine or OTC ranitidine in your home, schedule an appointment with your doctor to see if you can start taking an alternative. Your doctor may recommend an OTC antacid or lifestyle changes you can make to reduce problems caused by a build-up of stomach acid. Limiting alcohol, caffeine, and fatty foods are just three common examples.

The FDA also recommends properly disposing of all ranitidine products and to not purchase more until the Center for Drug Evaluation and Research has further studied the levels of n-nitrosodimethylamine found in ranitidine products. It will also consider reports from drugmakers if the company can prove that levels of NDMA do not increase to dangerous levels if scientists expose ranitidine products to heat that measures well above room temperature.

Could Your Cancer Be Associated with NDMA Contamination? 

The U.S. Food and Drug Administration had the legal and moral obligation to inform healthcare consumers of the risk of cancer once research proved a connection. However, that doesn’t mean these organizations or the drugmakers bear no responsibility if you developed cancer prior to the public disclosure of NDMA contamination present in certain ranitidine products.