In a major and concerning diabetes drug recall, the FDA has asked five companies to recall their versions of extended-release metformin. They are:
- Apotex – All lots
- Amneal – All lots
- Marksans (labeled as Time-Cap) – One lot (XP9004)
- Lupin – One lot (G901203)
- Teva (labeled as Actavis) – 14
If you’re taking metformin made by any of the above companies, click on the respective links and scroll down to find the NDC number. If the number matches the one on your product label, then call your doctor but do not stop taking your prescription, the FDA instructs.
These companies were specifically making metformin with more NDMA (Nitrosodimethylamine) then the FDA allows. Too much NDMA is linked to liver disease. The good news is that other companies are still manufacturing metformin, so not much of a shortage is expected. Also, an excess of NDMA was not found in immediate release, or IR, metformin products (which is the most commonly prescribed variety of the drug).
The FDA recommends: Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.
For the original press release, click here.