Glucient XR 500mg tablets - photo from Health Sciences Authority (HSA Singapore)
The Health Sciences Authority (HSA) said on Thursday (5 Dec 2019) that three types of metformin diabetes medications used by diabetics are being recalled after they were found to contain trace amounts of an impurity. The affected medications are one batch of Glucient XR Tablet 500mg supplied by Glorious Dexa Singapore and all batches of 750mg and 1000mg versions of Meijumet Prolonged Release Tablet, supplied by Pharmazen Medical.
Acceptable levels of nitrosamines are set in nanograms and is based on what is considered as reasonably safe if a patient continues to take the affected medicine every day for a lifetime of 70 years.
All three drugs were found to contain amounts of a type of nitrosamine impurity – known as N-nitrosodimethylamine (NDMA) – which are above the internationally acceptable level. HSA said that it has tested all 46 locally marketed metformin medicines and found that the other 43 drugs were not affected.
Acceptable levels of nitrosamines are set in nanograms and is based on what is considered as reasonably safe if a patient continues to take the affected medicine every day for a lifetime of 70 years.
All three drugs were found to contain amounts of a type of nitrosamine impurity – known as N-nitrosodimethylamine (NDMA) – which are above the internationally acceptable level. HSA said that it has tested all 46 locally marketed metformin medicines and found that the other 43 drugs were not affected.
Table for the list of recalled metformin medicines - HSA
As a precautionary measure, the Health Sciences Authority (HSA) is recalling these three metformin medicines that are used to control high blood sugar levels in diabetic patients [see above Table for the list of recalled metformin medicines].
HSA said that it is also working with the companies supplying these medicines as well as international regulatory agencies to verify the causes of the contamination, and to address the issue.
According to HSA, worldwide recalls have been conducted for the affected products.
HSA said that it is also working with the companies supplying these medicines as well as international regulatory agencies to verify the causes of the contamination, and to address the issue.
According to HSA, worldwide recalls have been conducted for the affected products.
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Patients taking the affected metformin medicines are advised not to stop treatment on their own, as the sudden stopping of medicines will raise blood sugar levels, which may pose a greater health risk.
Healthcare professionals have been advised by HSA to contact their affected patients to arrange for an exchange of their medicines as soon as possible. Patients who are concerned about their current treatment can speak to their doctor or pharmacist.
“The additional risk posed by NDMA from metformin, at the levels detected, is considered very low,” HSA said.
Healthcare professionals have been advised by HSA to contact their affected patients to arrange for an exchange of their medicines as soon as possible. Patients who are concerned about their current treatment can speak to their doctor or pharmacist.
“The additional risk posed by NDMA from metformin, at the levels detected, is considered very low,” HSA said.
HSA website announcement: "HSA Recalls Three out of 46 Metformin Medicines" on 4 Dec 2019
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