The U.S. Food and Drug Administration (FDA) issued a voluntary recall of a popular diabetes drug Metformin in late May. Doctors often prescribe this medication to help patients with the type 2 variety of the disease to help control their elevated blood sugar levels. Federal regulators recalled the drug after they discovered that it might contain a carcinogen.
FDA officials generally perform random testing on medications to determine whether they’re safe. The federal agency revealed on May 28 that its scientists identified that some of Metformin’s extended-release (ER) pills contained higher than acceptable intake limits of a nitrosamine impurity N-Nitrosodimethylamine (NDMA).
The FDA has previously identified NDMA as a substance that likely causes cancer. Pills manufactured by Marksans Pharma Limited, Teva Pharmaceuticals, Amneal Pharmaceuticals and Apotox Corp., are all affected by this recall. The FDA listed the specific lot numbers, manufacturing dates and production dates when announcing the recall.
The FDA also announced that it continues to collaborate with drug manufacturers to carry out the necessary testing of their medications so that problems like this don’t occur in the future. The federal agency did express concerns that the recall of this drug could result in patients’ inability to get their hands on it. An FDA spokesperson noted that they’re in close contact with manufacturers to reduce the chances of such an event happening.
Federal officials and drug manufacturers regularly perform testing on their medications to ensure that they’re not contaminated, contain the adequate dosage and to check on other quality control issues. The FDA often recommends or issues recalls after this. Drug manufacturers also often voluntarily do the same.
While government regulators or manufacturers often pull these drugs off the market before Louisiana patients get hurt, some don’t. It’s in such instances when you might want to consult with an attorney in Baton Rouge. They can hold manufacturers accountable for their lack of adequate testing, failure to adhere to quality standards or any other negligence.