其他安全警示

The United Kingdom: Metformin diabetes medicines – MHRA Update (English Only)

The Medicines and Healthcare products Regulatory Agency (MHRA) announces that it is aware that outside the United Kingdom (UK) very low amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in some metformin diabetes medicines.

Patients in the UK are advised to continue taking their metformin medicines as usual. The risks from not having adequate diabetes treatment far outweigh any possible effects of the low levels of NDMA seen in metformin medicines outside the UK.

As these metformin medicines are also available in Europe and outside the EU, the MHRA is working closely with the European Medicines Agency (EMA) and other regulatory authorities to determine whether any further action is required and will continue to keep patients updated as more information becomes available.

The levels of NDMA seen in the affected non-UK metformin medicines are very low and appear to be within or even below the range that people would normally be exposed from other sources, including food and water. If patients have any questions, they should speak to their healthcare professional.

Please refer to the following website in MHRA for details: http://www.gov.uk/government/news/metformin-diabetes-medicines-mhra-update

Currently in Hong Kong, there are 125 registered pharmaceutical products containing metformin. All products are prescription-only medicines. So far, the Department of Health (DH) has received 17 cases of adverse drug reaction related to metformin. None of them is concluded to be related to the presence of N-nitrosodimethylamine (NDMA).

Related news on the detection of NDMA in metformin products was previously issued by Singapore Health Sciences Authority (HSA), the United States Food and Drug Administration, and Health Canada, and was posted on the Drug Office website on 5 Dec 2019 and 6 Dec 2019. Letters to inform local healthcare professionals were issued by the DH on 6 Dec 2019. The DH has contacted the HSA for further information regarding the detection of NDMA in metformin products and reply is pending. The DH has been contacting the certificate holders of all registered metformin products for follow up on the local impact of the issue. The DH is collecting samples of metformin-containing products in the local market for analysis. When any health risks are posed to the public, a press statement will be issued as soon as possible. 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/ Saturday, December 7, 2019
Issued at HKT 15:15

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