Carcinogen Contaminated Versions of Diabetes Drug Metformin Found In South-East Asia
Source: Thailand Medical News Dec 08, 2019 4 years, 11 months, 1 week, 6 days, 16 hours, 33 minutes ago
Of the 46 different brands of
metformin, a
diabetes medication that is available in most South-East Asian countries, three versions are being recalled after they were found to contain unsafe levels of an impurity called
NDMA that can potentially cause cancer.
The Singapore Health Sciences Authority (HSA) tested all 46 locally marketed
metformin medicines and the remaining 43 are not affected. The recall comes even as health authorities worldwide are checking if the impurity, carcinogen earlier found in heart and gastric drugs, might also be found in unsafe levels in
diabetes drugs that are widely used.
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The Recalled Metformin Brands (Credit: HSA)
The Singapore HSA authorities said last week that that three
metformin drugs were found to contain trace amounts of a nitrosamine impurity, called
N-nitrosodimethylamine (
NDMA), which are above the internationally acceptable level.
NDMAs are classified as potential carcinogens for humans.
For safety purposes, the Singapore, HSA said that it is recalling the three affected drugs, which are used to control high blood sugar levels in diabetic patients.The recall is only applied for Singapore. So far there has been no comments or actions from health authorities from Malaysia, Thailand, Indonesia, Philippines and also Vietnam, where the drugs are also available.
Brands involved in the recalled drugs are: one batch of Glucient XR Tablet 500mg, supplied by Glorious Dexa Singapore; and all batches of Meijumet Prolonged Release Tablet in 750mg, and 1,000mg versions, supplied by Pharmazen Medical.
Individuals taking the affected
metformin medicines are advised not to stop treatment on their own, as doing so suddenly will raise blood sugar levels, which may pose a greater immediate health risk than the trace amounts of
NDMA in the affected medicines.
The Singapore HSA has also advised healthcare professionals to contact their patients who are taking the affected drugs and arrange for an exchange of their medicines as soon as possible.
Individuals who are concerned about their current treatment should speak to their doctor or pharmacist.
NDMA nitrosamine impurity found in the diabetes drugs is a known carcinogenic compound that is able to cause cancer in humans.
NDMA can be found in food or the environment. They are commonly found in low levels in processed food including pickled vegetables, salted fish, processed meat products such as bacon and sausages and in polluted air.
Recently, Nitrosamine impurities have recently also been found to be formed unexpectedly during the manufacture of some medicines especially in high blood pressure drugs, acid reflux drugs and also heart medications from China. Recalls were done worldwide for affected products found to contain these impurities above acceptable levels.
The United States Food and Drug Administration (FDA) said that it is testing samples of
metformin
rong> sold in the US for NDMA.The agency will recommend recalls of the medication as appropriate. The European Medicines Agency said on the same day that companies should test for high levels of NDMA in metformin.
Thailand Medical News advises individuals who are taking metformin to check online if the brands that they are taking are the same as the brands that are being recalled and if so, they are to immediately contact their doctors or hospitals to seek safer brands or substitutes. 
