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European Union: EMA update on metformin diabetes medicines (English Only)
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The European Medicines Agency (EMA) announces that it is aware that trace amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in a small number of metformin diabetes medicines outside the European Union (EU). The levels of NDMA in the affected non-EU metformin medicines are very low and appear to be within or even below the range that people can be exposed to from other sources, including certain foods and water. At this point, there are no data indicating that EU metformin medicines are affected. Authorities in the EU are in the process of working with companies to test EU medicines and will provide further updates as more information becomes available. Patients in the EU should continue taking their metformin medicines as normal. The risk from not having adequate diabetes treatment far outweighs possible effects of the low levels of NDMA seen in tests. Healthcare professionals should remind patients of the importance of keeping their diabetes under control. Metformin is widely used alone or in combination with other medicines to treat type 2 diabetes. It is usually the first-line treatment, and it works by reducing the production of glucose in the body and reducing its absorption from the gut. Information for patients and healthcare professionals Patients: - Metformin is an effective medicine for controlling blood sugar. - Continue taking your metformin medicine to keep your diabetes under control. - Stopping treatment could make your diabetes become uncontrolled and leave you open to symptoms caused by high blood sugar, including thirst, drowsiness and blurred vision. - Long-term complications of uncontrolled diabetes include heart disease, nerve problems, kidney damage, eye problems and damage to the foot that can lead to amputation. Healthcare professionals: - Continue prescribing metformin medicines as normal and await further information from authorities in the EU. - Advise your patients against stopping their diabetes treatment. - Remind your patients of the importance of keeping their diabetes under control. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies. It is present in some foods and in water supplies, but it is not expected to cause harm when ingested in very low levels. Please refer to the following website in EMA for details: http://www.ema.europa.eu/en/news/ema-update-metformin-diabetes-medicines 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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