The U.S. Food and Drug Administration (FDA) warned in a statement this week that its lab had found potentially carcinogenic impurities in some of its popular diabetes drug metformin,media reported. The discovery involves “several batches” of metformin reprieves (ERs), for which the FDA is seeking voluntary recalls of their drugs from five different companies.
Laboratory tests on metformin found that several batches of metformin release tablets contained an unacceptable lycine, N-nitromedmethamphetamine (NDMA), a form of nitrosamines, according to a fda release Thursday. The NDMA levels found in these batches exceed the maximum acceptable limit set by the FDA.
The unnamed companies have not yet issued a recall notice, but the FDA says it has contacted five companies and asked them to voluntarily recall products. Although the FDA did not release the names of the companies, the statement noted that there were similar problems in other companies, but not so serious that no recall was needed.
It is not clear whether the recall will lead to a shortage of metformin. In response to this question, the FDA responded by working with manufacturers in the hope of preventing shortages, but if it did, it would try to reduce any possible impact. In addition, the FDA warns that even if the drugs are recalled, patients should take them until they are found, because the risk of type 2 diabetes without treatment is greater than the risk to their body.
In fact, this is not the first time that the levels of impurities found in metformin are too high, and the FDA announced last year that it had found similar problems in drugs sold in other countries.