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Singapore: HSA Recalls Three out of 46 Metformin Medicines (English only)

Health Sciences Authority (HSA) announces that three metformin medicines have been found to contain trace amounts of a nitrosamine impurity, N-nitrosodimethylamine (NDMA), which are above the internationally acceptable level. 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. The affected products are:
- Glucient XR Tablet 500mg (batch number: 2881382)
- Meijumet Prolonged Release Tablet 750mg, Meijumet Prolonged Release Tablet 1000mg (all batches)

HSA has tested all 46 locally marketed metformin medicines. 3 out of 46 metformin medicines were found to contain NDMA above the acceptable level. The other 43 metformin medicines are not affected.

The risk to patients who have been taking the 3 affected metformin medicines is very low. This is because the potential risk of nitrosamines is associated with long-term use, and the 3 affected medicines have only been supplied locally for a short period of time since last year.

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 who are taking the affected medicines to arrange for an exchange of their medicines as soon as practicable. Patients who are concerned about their current treatment can speak to their doctor or pharmacist.

Please refer to the following website in HSA for details: http://www.hsa.gov.sg/announcements/news/hsa-recalls-three-out-of-46-metformin-medicines

In Hong Kong, the above products are not registered pharmaceutical products.

Currently in Hong Kong, there are 125 registered pharmaceutical products containing metformin. All products are prescription-only medicines. So far, the DH has received 17 cases of adverse drug reaction related to metformin. None of them is concluded to be related to the presence of NDMA. The DH has contacted the HSA for further information regarding the detection of NDMA in metformin products. Its reply is pending. The DH will contact the certificate holders of all registered metformin products for follow up on the local impact of the issue. The DH will remain vigilant on the development of the issue and any safety update of the drug issued by overseas drug regulatory authorities for consideration of any action deemed necessary. Patients who are taking metformin-containing products should not stop taking the medicines, but should seek advice from their healthcare professionals for proper arrangement.

Ends/ Thursday, Dec 5, 2019
Issued at HKT 16:00

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