Due to contamination and cancer risks, the US Food and Drug Administration published a voluntary recall by Nostrum Laboratories. The advisory expands on several type two diabetes medications; Mertormin HCL Extended-Release Tablets.
What is Metformin?
Metformin is a common medicine for treating type 2 diabetes and prevents it if a person is at high risk.
It works by lowering a person's blood sugar by improving the body's handling of insulin -- a hormone that regulates sugar levels. Metformin is usually prescribed to patients when diet and exercise alone aren't enough to control blood sugar levels.
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Why the Metformin Recall?
There have been numerous voluntary recalls of metformin in 2020, all with potentially high N-Nitrosodimethlamine (NDMA) levels, a possible carcinogenic substance.
NDMA is a hepatotoxic agent and carcinogenic contaminant. It is frequently used in medications like Losartan, irbesartan, valsartan, and ranitidine. NDMA can be produced during the manufacturing stage when introduced from contaminated ingredients.
The FDA has already established a maximum dose of NDMA per tablet. On the other hand, many facets of NDMA contaminations still require rigorous investigation.
Initially, the recall by Nostrum Laboratories was issued In November, with the new recall being an expansion of the previous. The current recall expands over the Metformin HCL Extended-Release Tables in 750mg dosages.
According to the notice, the tablets are off-white with debossed ID 'NM7". The tablets are packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01 that is set to expire on May 2022.
Nostrum Laboratories stated that most of the tablets were distributed across US wholesalers who are being notified of the recall.
The recall came due to unacceptable doses of NDMA, way above the FDA limit. Nostrum has not received reports of adverse effects related to the recent recalls.
The Food and Drug Administration published a recall list for metformin while alerting patients and health professionals of the recent recall. The FDA warns patients to consult doctors if they are currently on metformin medication.
Other than Nostrum Laboratories, similar recalls have been called by Markans Pharma and Sun Pharmaceutical Industries due to similar reasons.
Recent FDA testing shows that immediate-release (IR) metformin--the most commonly prescribed metformin-- has shown no traces of NDMA.
What to Do if You're Taking Metformin?
As echoed by the US FDA, patients currently taking metformin should be aware of the situation. The agency has published a list of manufacturing information regarding contaminated batches.
It would be highly dangerous for patients to stop taking metformin immediately. Hence, as stated by the FDA, patients should seek out professional advice regarding their medication. Should the need be, they can be prescribed different drugs or ultimately have a different treatment.
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