Three types of diabetes medication recalled for impurities
Three types of metformin diabetes medications are being recalled by the Health Sciences Authority (HSA) after they were found to contain trace amounts of a contaminant.
The HSA said on Wednesday that the affected medications are batch 2881382 of Glucient XR Tablet 500mg supplied by Glorious Dexa Singapore, and all batches of the 750mg and 1000mg versions of Meijumet Prolonged Release Tablet, supplied by Pharmazen Medical.
The medicines, which are used to control high blood sugar levels in diabetic patients, have been found to contain trace amounts of a type of nitrosamine impurity, N-nitrosodimethylamine (NDMA), above the internationally acceptable level.
The HSA said that it has tested all 46 locally marketed metformin medicines. The other 43 metformin medicines are not affected.
The risk to patients who have been taking the three affected metformin medicines is very low, added HSA.
"This is because the potential risk of nitrosamines is associated with long-term use, and the three affected medicines have only been supplied locally for a short period since last year," said the HSA.
It also stressed that the additional risk posed by NDMA from metformin, at the levels detected, is considered very low. For example, the added cancer risk from an additional six-month exposure is estimated to be less than 0.00002 per cent.
HSA stressed that 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 than the trace amounts of NDMA in the affected medicines.
HSA has advised healthcare professionals to contact their patients taking the affected medicines to arrange for an exchange of their medicines.
HSA said NDMA is commonly found in low levels in processed food such as pickled vegetables and bacon. Nitrosamine impurities were found recently to be formed unexpectedly during manufacture of some medicines.
Recalls had been undertaken worldwide for affected products found to contain these impurities above the acceptable levels.
HSA is working with the suppliers of these medicines and international regulatory agencies to verify the causes of the contamination, and to identify the necessary measures to address the issue.