Based on the results of laboratory tests, NDMA is a “probable human carcinogen.” According to the U.S. Food & Drug Administration (FDA), NDMA may cause cancer in humans. The World Health Organization (WHO) has found that exposure to high levels of NDMA may cause gastric or colorectal cancer. NDMA has also been linked to serious liver damage and internal bleeding. Even exposure to small amounts of NDMA may cause liver damage.
How People Can Be Exposed to NDMA
According to the FDA, nitrosamines, such as NDMA, are chemicals that may cause cancer. They are found in a variety of foods, including grilled and cured meats, vegetables, and dairy products. The FDA states that small amounts of NDMA in food and water are not believed to put people who consume them at higher risk of developing cancer.
Nitrosamines are found in some medications because of a drug’s chemical structure, the manufacturing process, or storage and packaging conditions. The human body can also form nitrosamines as it processes food and medication.
NDMA has been found in Zantac, which is also known by its generic name, ranitidine. According to MedlinePlus, Zantac belongs to a class of medications known as histamine-2 blockers that reduce the amount of acid produced in the stomach. Zantac and ranitidine can be used to treat conditions such as ulcers, gastroesophageal reflux disease (GERD), gastrointestinal bleeding, and heartburn.
The amount of NDMA in ranitidine products can increase if a medication is exposed to high temperatures, which may occur during distribution or storage. Consumers can then be exposed to unsafe levels of NDMA.
The FDA is working to identify the source of NDMA in ranitidine. Tests that the FDA conducted found NDMA in both finished medication and the active pharmaceutical ingredients that were used to make Zantac. Tests that were designed to simulate conditions in the human digestive system demonstrated that NDMA was not formed when Zantac was broken down in the body.
The amount of NDMA in Zantac may also increase in normal storage conditions, simply due to the passage of time. Individuals who are exposed to higher-than-acceptable levels of nitrosamine impurities over a long period of time may have an increased risk of developing cancer.
The FDA and Evidence of NDMA Carcinogens in Zantac
In September 2019, the FDA began reacting to information about the presence of a possible carcinogen in Zantac. In April 2020, the FDA began requesting a “market withdrawal” of ranitidine products, although this was not an official recall of the product as defined by the FDA. Companies can voluntarily recall these medications, but the FDA can still release updates to the status of the drug.
FDA tests were not as conclusive as those reported by other laboratories, but the FDA advised people to stop taking over-the-counter ranitidine, dispose of any medication they had, and use another over-the-counter treatment. They recommended that patients taking prescription drugs that may contain nitrosamine impurities discuss the risk with their doctor and ask if they should switch to another medication.
Alternatives to Zantac
As manufacturers and distributors pull Zantac and ranitidine from the shelves, anyone suffering from a condition that required Zantac still have other options to treat their issues. There are other drugs in the H2-blocker category such as famotidine (Pepcid) that may be a safer alternative to some individuals.
Other types of heartburn medications include proton pump inhibitors (PPIs) and antacids. PPIs include drugs like omeprazole and esomeprazole, known by the brand names Prilosec and Nexium 24, respectively. H2-blockers and PPIs typically require a prescription, although you may find some over-the-counter versions. Antacids can help with less severe cases of heartburn, and they are easy to find over the counter in pharmacies and grocery stores. Tums are one such example.
Like all medications, alternatives to Zantac still can have side effects particular to the medicine type, as well as the individual taking the medicine. Any taking these medications should still follow a doctor’s instructions or the directions on the label, even if a medical professional does not prescribe them.
What to Do If You Believe You Were Injured by Zantac
According to USA Today, Zantac has been sold for decades, and millions of people around the world have taken the drug. Despite its widespread and long-term use, Zantac was only recently found to contain NDMA.
If you took Zantac, either in a prescription or over-the-counter form, and you later developed cancer, the likely carcinogen NDMA may be to blame. Pintas & Mullins Law Firm may be able to pursue a fair financial settlement to compensate you for the physical harm you endured, as well as pain and suffering, emotional distress, and lost wages.
Pintas & Mullins Law Firm works on a contingency basis, meaning you will not have to pay us unless we obtain a settlement or payout on your behalf. If you believe you were injured by NDMA in Zantac or another medication that contained ranitidine, call our office at (800) 794-0444 to talk to a member of our staff about how we may be able to help you seek justice.