Drug Recall: Diabetes Medicine Contains Carcinogens

The FDA has recalled Metformin, a diabetes drug due to high levels of NDMA — (Photo : Photo by qimono from Pixabay )

A recent drug recall has been made for five versions of a diabetes drug due to contamination. The Food and Drug Administration (FDA) has declared the drug Metformin positive for N-Nitrosodimethylamine (NDMA), which is a possible cancer-causing chemical.

In a report from ABC News, the FDA has asked pharmaceutical companies to voluntarily return batches of diabetes medications, which they posted online. One of those included on the FDA site is metformin hydrochloride ER USP 500 mg tablets, which are under Apotex Corporation.

FDA Acting Director for Drug Evaluation and Research Patrizia Cavazzoni, M.D. explained their recent finding on the FDA website:

"The FDA has strict standards for safety, effectiveness, and quality, and the agency makes every effort based on science and data to help keep the U.S. drug supply safe. We understand that patients may have concerns about possible impurities in their medicines, and want to assure the public that we have been looking closely at this problem over many months in order to provide patients and health care professionals with clear and accurate answers."

The government agency was made aware of the presence of NDMA in some metformin tablets in other countries, which made them asked suppliers and manufacturers to test all batches. This is to make sure that acceptable standards are maintained in the market without any trace of impurities.

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At the same time, the FDA added in their press release, that doctors should advise their patients to continue taking the drug until they are given a substitute. They assured that NDMA is only dangerous when one is exposed to higher doses and looks forward that short-term exposure will not increase the probability of cancer.

Due to product drug recall from five companies, the agency is still hopeful that there will be no shortages for the need for this medication, as mentioned in Fox Business. However, in a worst-case scenario, they will try to work it out with the manufacturers to avoid and lessen the effect it will have on the pharmaceutical markets. It should also be taken into consideration that there are a certain number of companies that sell generic versions of the drug which have the same impurities.

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Type 2 diabetes patients have been known to use these tablets to help in the reduction of sugar in their blood. Some of them will use the Metformin by itself or will combine it with other medications as a way to manage their sugar levels.

However, the FDA remained mum on the other four pharmaceutical companies who have also required a massive withdrawal of their products from the shelves.

Prior to these findings, there were several drug recalls last year, which also contained NDMA, as reported by KSL.