FDA Announces Recall of Diabetes Drug Metformin for Cancer-Causing Agents
Medical experts called out on people with diabetes and are taking prescription medication to manage their blood sugar that might be the time to contact their doctors.
The commonly-taken diabetes medicine, metformin, is reportedly being recalled because of potentially hazardous contamination.
The Food and Drug Administration announced early this month that the most recent recall of metformin manufactured by Marksans Pharma and Sun Pharmaceutical Industries because of the potential existence of cancer-causing agents known as "nitrosamines."
According to reports, the said recall engaged "500 milligram and 700 milligram extended release tablets." The FDA noted that the "immediate-release metformin" does not seem to be contaminated.
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Avkare and several other manufacturers are recalling the drug, which is used to treat people with type 2 diabetes, after high levels of N-nitrosodimethylamine (NDMA) impurities, a known carcinogen, have been found in the tablets.
Under FDA's Investigation for its Nitrosamine Content
Since December last year, metformin has been being investigated by the FDA for the nitrosamines it contains. Nitrosamines are popularly known as a "carcinogenic agent."
Such an investigation and the recalls are following the same instances where famous medications for blood pressure and heartburn like Zantac, for one, were found to be contaminated, as well.
According to the FDA, these nitrosamines' source remains unknown. In addition, the government agency has asked that the pharmaceutical firms test their products for nitrosamine levels prior to their release and availability for sale on the market.
If the nitrosamine levels found are above the acceptable limit, drug makers need to report their findings to the FDA.
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Increased Risk of Cancer
According to the FDA, the real risk from nitrosamines is unclear, although they can lead to increased risk of cancer "over a long period of time."
Nevertheless, they were certain to mention that they were not anticipating that shorter-term exposure at levels higher than the acceptable limit of intake would result in an increase in cancer risk.
Having gathered this, the experts' advice is that it is not a good idea just to stop taking metformin. Suppose one has type 2 diabetes and is taking medicine. In that case, the FDA suggests he should consult with the doctor immediately for a replacement medicine or prescription before deciding to stop using the drug, as this could lead to serious risks to health.
Initial Recall First Announced in June
The FDA announced this week that, as earlier mentioned, metformin has been recalled because it has excess levels of cancer-causing agents.
Marksans Pharma Limited, the drug's maker, has extended a recall first announced in June to now include 76 lots of unexpired medications.
The recalled medicines are reportedly marketed as "extended release tablets" with Time-Cap Labs, Inc. as the brand name.
Furthermore, the drug helps lower levels of blood sugar of people who have type 2 diabetes. However, the recalled product had an unexpectedly high "N-Nitrosodimethylamine or NDMA" content, which is regarded as a possible human carcinogen.
In its announcement, the FDA outlined, the drug manufacturer performed NDMA testing of its unexpired identified marketed lots. As a result, Marksans observed that NDMA content in several lots is higher than the acceptable ADI or acceptable daily intake limit of 96ng/say.
Despite the recall, the FDA advised users to continue the intake of the recalled tablets until a doctor provides a replacement or substitute treatment option.
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Oct 15, 2020 12:49 AM EDT
