On May 28, the FDA announced(www.fda.gov) that it had asked five pharmaceutical firms to voluntarily recall products containing extended-release formulations of metformin hydrochloride, a drug frequently prescribed to patients with type 2 diabetes to manage blood glucose levels.
The recall stems from a recent series of tests that revealed unacceptably high levels of N-nitrosodimethylamine, a probable human carcinogen, in several lots of metformin extended-release products.
“Now that we have identified some metformin products that do not meet our standards, we’re taking action, “said Patrizia Cavazzoni, M.D., acting director of the agency’s Center for Drug Evaluation and Research, in a press release.(www.prnewswire.com) “As we have been doing since this impurity was first identified, we will communicate as new scientific information becomes available and will take further action, if appropriate.”
Companies Notified
FDA officials said in a May 29 conference call that the firms that have been contacted are
- Actavis Pharma Inc.,
- Amneal Pharmaceuticals, LLC,
- Apotex Corp.,
- Lupin Pharma and
- Marksans Pharma Ltd.
The FDA is recommending that clinicians continue to prescribe metformin when clinically appropriate. In addition, the agency recommends that patients continue taking metformin products even after recalls occur until they can consult with their physician to receive a replacement prescription or different treatment option.
All manufacturers of metformin-containing ER products are being asked to evaluate the risk of excessive NDMA in their products and to test each batch before releasing it into the U.S. market. If testing shows NDMA above the acceptable intake limit, the manufacturer should inform the agency and halt release of the batch.
It should be noted that the recall does not apply to immediate-release metformin products.
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