After it was discovered that metformin products sold outside of the United States contained the carcinogenic chemical N-Nitrosodimethylamine (NDMA), the U.S. Food and Drug Administration (FDA) announced that it would be investigating whether the generic diabetes medication is affected by the same cancer-causing substance that has resulted in a rash of valsartan and Zantac recalls over the past year. If you or a loved one took metformin or another medication that may have been contaminated with NDMA, and you have since been diagnosed with stomach cancer or another type of cancer, contact a knowledgeable product liability lawyer today to explore your potential compensation options.
Metformin is a prescription medication commonly used to control high blood sugar levels in individuals with type 2 diabetes. The drug is widely prescribed in the United States and other countries and is sold under a number of brand names, including Fortamet, Diabex, Riomet, Glucophage and Carbophage. In testing all 46 locally marketed metformin medications in Singapore, the Health Sciences Authority (HSA) recently found NDMA in three versions of the diabetes drug and subsequently recalled the contaminated products as a precaution. According to the HSA, although only trace amounts of NDMA were found in the metformin drugs, the amounts found are above the internationally acceptable level.
In a statement released on December 5, the FDA indicated that it has been investigating the presence of NDMA and other nitrosamines in certain types of medications, including angiotensin II receptor blockers (ARBs), ranitidine (Zantac) and other drugs. And because NDMA was found in versions of metformin sold in other countries, the FDA has added metformin to its list of drugs to investigate. According to the FDA’s statement, “The FDA is aware that some metformin diabetes medicines in other countries were reported to have low levels of NDMA,” a cancer-causing chemical linked to liver damage, cancer and other serious side effects. Ranitidine, too, was reported to contain “low levels” of NDMA and still, people across the country are filing legal claims alleging that their use of Zantac caused them to develop stomach cancer, liver cancer, colorectal cancer and other cancers of the digestive tract.
Concerns about the potential risk of NDMA in pharmaceutical drugs first began to emerge last year, after it was discovered that several popular blood pressure medications, including valsartan, losartan and irbesartan, were tainted with NDMA and other cancer-causing impurities. It was reported at that time that the NDMA in those drugs was likely a byproduct of changes in the generic drug manufacturing processes at factories in China and India. As a result of these findings, the FDA established an acceptable daily intake limit of NDMA, requiring that any medications with levels of NDMA higher than 96 nanograms be recalled. An independent pharmacy called Valisure also established new testing procedures to detect potentially dangerous levels of NDMA in the drugs it sells, and in June, the pharmacy found that most versions of the heartburn drug Zantac contained unacceptable levels of NDMA. This finding has resulted in a flurry of Zantac and generic ranitidine recalls in recent months.
According to the FDA, carcinogenic chemicals like NDMA can increase the risk of cancer in people who are exposed to them at levels above the limit established by the FDA and over long periods of time. The primary concern regarding the presence of NDMA in valsartan, Zantac, metformin and other pharmaceutical drugs is the underlying cause of the impurity. Unlike valsartan, which was contaminated by NDMA as a byproduct of the manufacturing process, it was discovered that the NDMA in Zantac may have been caused by the instability of the drug’s active ingredient, which is what led to concerns about the potential risk of NDMA exposure from other generic and brand-name medications.
Due to the presence of NDMA, regulatory agencies in other countries may be recalling metformin, but as of now, there is no metformin recall in the United States. The FDA has announced that it will be investigating whether metformin products in the U.S. contain NDMA and will recommend recalls as necessary if high levels of the carcinogen are found. “If these reports are true, it could be a big blow to many millions of people on [metformin],” says Dr. Ranit Mishori, a professor of family medicine at Georgetown University. “There are many other alternatives and other medication classes but many of them have side-effects, are more expensive and some of the newest ones may not be covered by insurance.”