Metformin is the fourth most prescribed drug in the country. It is used to treat people with type II diabetes to control high sugar levels. Online pharmacy Valisure tested the widely used diabetes drug Metformin and found that it contained high levels of the probable cancer-causing agent NDMA. Valisure is now calling on regulators to recall the popular drug.
NDMA Found in Metformin
Valisure’s testing found NDMA in 16 batches of Metformin manufactured by 11 different companies. The highest levels were detected in a batch from Amneal Pharmaceuticals. According to Valisure’s findings, the batch was found to have more than 16 times the acceptable level of NDMA.
Do We Need a Recall?
Valisure submitted a petition to the Food and Drug Administration (FDA) in February asking the regulator to investigate the drug and possibly issue a recall. While the FDA does not have the power to institute a recall of a drug, it can request one from the manufacturer. The FDA stated that in December, it had tested samples of Metformin and that the agency would recommend a recall if it felt one was warranted. The FDA’s recent testing found low levels of NDMA in Metformin, but these levels were not higher than the acceptable limit, which is 96 nanograms a day. There were recent recalls of Metformin in other countries. NDMA testing by government labs in Singapore and Canada led to recalls of Metformin.
It is not clear why Valisure’s results differ from the FDA’s. According to Valisure, the company largely followed the FDA’s testing protocol. Depending on the product, NDMA can be produced during the manufacturing process, while the drug is being stored, or even be a part of the drug itself. Valisure believes that in the case of Metformin, the contamination occurred during the manufacturing process. However, it is possible that some aspects of the drug itself may be the source of contamination.
Random quality testing of drugs on the market by companies like Valisure is an important tool for keeping the public safe. In 2018, during random tests, Valisure discovered NDMA in Valsartan and Losartan, popular blood pressure medications. In 2019, similar tests discovered a problem with drugs containing ranitidine, an active ingredient in heartburn medications. The FDA does not test drugs as frequently as private companies like Valisure, so these randomized tests are very important.
Contact a Product Liability Attorney
If you’ve developed cancer after long-term use of Metformin, you should have an experienced product liability attorney evaluate your case. Gregg Goldfarb has over 20 years of experience helping the victims of dangerous drugs. Contact us online or call us at 305-374-7000 to schedule a free consultation.