Following a string of Zantac recalls issued over the past several months due to the presence of the carcinogenic chemical N-nitrosodimethylamine (NDMA), another drug commonly prescribed for heartburn is being pulled from the market for similar reasons. The U.S. Food and Drug Administration (FDA) announced a recall of generic nizatidine on January 8, after it was discovered that the active ingredient in Mylan’s generic Axid drug contained trace amounts of NDMA, an industrial contaminant that is known to cause cancer. If you or someone you know took Axid or generic nizatidine and you have since been diagnosed with cancer, your diagnosis could be linked to NDMA exposure. Contact a reputable product liability lawyer today to find out if you are eligible to file a lawsuit against the drug manufacturing company.
NDMA is a chemical that has been classified by the Environmental Protection Agency as a probable human carcinogen, meaning it has the potential to cause cancer in humans, and the chemical has recently been detected in a number of widely used generic and brand-name medications, including Zantac. In September 2019, the FDA issued a statement alerting patients and healthcare providers about the presence of NDMA in samples of the heartburn drug ranitidine (Zantac), which has been on the market in the United States for more than three decades and is considered the world’s best-selling drug. Prior to the widespread Zantac and ranitidine recalls, which resulted in nearly every version of the heartburn drug being pulled from the market, the generic blood pressure drugs valsartan, losartan and irbesartan were also found to contain NDMA, in addition to other potentially dangerous carcinogenic impurities, at levels the FDA considered “unacceptable.”
Laboratory testing of ranitidine identified the carcinogen NDMA “in every lot tested, across multiple manufacturers and dosage forms of the drug,” but it has not yet been discovered why the medications contain the cancer-causing chemical. Unlike the NDMA detected in valsartan, losartan and irbesartan, which experts believe occurred as a byproduct of the generic manufacturing process, the leading theory with regard to Zantac is that the ranitidine molecule may be inherently unstable and may generate high levels of NDMA when digested by the human body. Research has shown that people who take ranitidine to treat heartburn and other conditions have high levels of NDMA in their urine, which suggests that the chemical is produced in the body.
The wave of Zantac recalls issued since September 2019 came after an independent pharmacy known as Valisure detected NDMA in Zantac and its generics during routine testing. This more recent drug recall involves nizatidine capsules sold by Mylan Pharmaceuticals and indicates that trace amounts of NDMA were detected in the active pharmaceutical ingredient manufactured by Solara Active Pharma Sciences Limited. According to the FDA, nizatidine, sold under the brand name Axid, is indicated for the short-term treatment of ulcers affecting the stomach and intestines as well as certain conditions of the stomach and esophagus, such as erosive esophagitis and gastroesophageal reflux disease (GERD).
Amid growing concerns about the safety of Zantac and other widely used heartburn medications, the FDA launched an investigation into the presence of NDMA in Zantac and advised companies to recall their ranitidine products if testing showed levels of NDMA above the acceptable daily limit of 96 nanograms per day. In early November, the FDA issued a statement on the results of its ongoing ranitidine testing and noted that the agency had identified NDMA in nizatidine pills as well. At that time, the FDA called for “manufacturers to voluntarily recall nizatidine, commonly known as Axid, if they found NDMA above the acceptable daily intake level because it is chemically similar to ranitidine.”
Mylan’s recent nizatidine recall appears to be the first voluntary Axid recall linked to the ongoing NDMA investigation and it comes as a growing number of Zantac lawsuits are being filed by consumers who allege that they developed cancer because of the recalled heartburn drug. The claims currently pending in the Zantac litigation allege that drug makers Sanofi and Boehringer Ingelheim knew or should have known that their ranitidine products were contaminated with NDMA and failed to provide adequate warnings to consumers and the medical community. If it is revealed that users of Axid and generic nizatidine were also exposed to potentially dangerous levels of the carcinogen NDMA, it won’t be long before Mylan and other drug companies begin to face similar product liability lawsuits.