其他安全警示

The United States: FDA posts laboratory testing results for NDMA levels in metformin (English only)

The US Food and Drug Administration (FDA) announces that it posted laboratory results showing N-nitrosodimethylamine (NDMA) levels in some metformin products approved in the United States. FDA has determined that the levels of NDMA in metformin products tested range from not detectable to low levels. To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the United States.

Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. Patients should continue taking metformin to keep their diabetes under control. It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.

FDA plans to post the methods used in laboratory testing of metformin in the near future. FDA is also collaborating with international regulators to share testing results for metformin, along with testing results for other drugs. FDA will continue to monitor NDMA in metformin, along with other drugs products, and will provide timely updates of new developments, including product recalls.

Please refer to the following website in FDA for details: http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin

Currently in Hong Kong, there are 124 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) and other overseas drug regulatory authorities, and was posted on the Drug Office website since 5 Dec 2019, with the latest update posted on 13 Dec 2019. Letters to inform local healthcare professionals were issued by the DH on 6 Dec 2019. The DH has contacted HSA for further information regarding the detection of NDMA in metformin products and reply is pending. The DH has contacted the certificate holders of all registered metformin products for follow up on the local impact of the issue. The DH has collected 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/Tuesday, Feb 4, 2020
Issued at HKT 15:00

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