In early October, the FDA announced a recall of diabetes drug metformin hydrochloride due to the presence of a possible cancer-causing agent. In its announcement, the FDA explained that drug manufacturer Marksans detected unsafe levels of NDMA, a probable carcinogen, in certain batches of metformin.
Metformin helps lower glucose levels by restricting the amount of sugar the liver releases into a patient’s bloodstream. Metformin itself, the drug’s main active ingredient, is not toxic in itself. However, the FDA noted that certain fast-release capsule forms of metformin contain higher-than-safe levels of NDMA, which the FDA has previously noted as a probable human carcinogen. According to the FDA’s website, the agency is still uncertain why certain fast-release metformin capsules contain NDMA. The source is currently under investigation.
Unfortunately, many patients who were prescribed the tainted drug may have to continue taking it. The FDA advised users not to stop taking metformin until their doctors could prescribe a replacement drug. Going off of the drug could cause a sudden in glucose levels, and “could be dangerous for patients with type 2 diabetes.”
Some patients are already taking legal action against Marksans. In April, an Indiana woman filed a class-action lawsuit against the manufacturer. The plaintiff states several causes of action, including fraud, breach of warranties, and fraudulent concealment. Her complaint alleges that that Marksans knew of and concealed metformin’s cancer risks from consumers until after the recall. The case will be heard by the U.S. District Court for the District of New Jersey.
If you or a loved one were diagnosed with cancer after taking recalled, fast-release metformin, contact the defective drug and products liability attorneys at David Randolph Smith for a free consultation.