FDA Asking Drug Companies to Voluntarily Recall Extended Release Meformin
The Type-2 Diabetes medication, Metformin (Extended Release), is being cited for high levels of NDMA. The FDA is asking companies to voluntarily recall this prescription drug.
NDMA, a chemical byproduct, has been found in the Extended Release (ER) versions of the widely used diabetic drug metformin. Only ER versions of this drug have been impacted at this time, but recalls continue to rise. NDMA is a likely human carcinogen and has been found in some of these drugs at unsafe levels.
More than five months after initially sounding the warning about NDMA contamination in some Extended Release metformin medications, the Food and Drug Administration continues to expand recalls. In working closely with manufacturers, it is continuing to find unsafe levels of this likely human carcinogen in lots of the common diabetic medication from several manufacturers. These recalls have, so far, been initiated by manufacturers as voluntary recalls.
See the ongoing FDA updates HERE.
To see the list of recalled metformin products, click HERE.
What Your Clients Should Know
Metformin is still considered a safe drug for the treatment of some forms of diabetes. It is the chemical byproduct that was found to be present, not metformin itself, that poses a danger. If a client has one of the recalled drugs in their possession, they should call their doctor or pharmacist for a replacement. If they have concerns about course of treatment or their prescriptions, they should reach out to their doctor.
Sources:
- Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)
- FDA Asks Companies to Recall Diabetes Medication Metformin Over Cancer-Causing Chemical
- FDA requests voluntary recall of contaminated metformin products