其他安全警示

Australia: Metformin: TGA investigation: potential contamination with N-nitrosodimethylamine (English only)

The Therapeutic Goods Administration (TGA) is aware that some overseas regulators have detected low levels of N-nitrosodimethylamine (NDMA) in a small number of metformin products.

It has not yet been confirmed that NDMA is present in any metformin products supplied in Australia. The TGA is working with other international regulators and medicine sponsors to further investigate this issue and determine what actions may be required.

It is critical that patients do not stop taking their metformin medicines unless instructed to by their health professional.

NDMA is a type of N-nitroso compound. N-nitroso compounds are commonly found in low levels in a variety of foods, particularly smoked and cured meats, as well as in some drinking water and in air pollution. Long-term exposure, over many years, can increase an individual's risk of developing cancer. The additional risk that would be posed by any potential trace levels of NDMA being detected in metformin is considered to be very low. Please be aware that it has not yet been confirmed that NDMA is present in any metformin products supplied in Australia. It is also important to note that even if NDMA is detected in some Australian products, it is likely that not all products or all batches will be affected.

If patients take metformin, do not stop their treatment without first consulting a doctor or pharmacist. It is very important to keep diabetes under control and stopping their diabetes medicines poses a greater and more immediate risk to health than potential low-level contamination with NDMA. Complications associated with uncontrolled diabetes include heart disease, nerve problems, kidney damage, eye problems and damage to the foot that can lead to amputations. If they have any questions or concerns about this issue, they should speak to their health professional.

Health professionals should be aware of this potential issue and advise patients accordingly. There is no reason to stop prescribing metformin. It has not yet been confirmed that NDMA is present in any metformin products supplied in Australia. Health professionals may wish to remind patients of the importance of keeping diabetes under control and reassure them that that the risks posed by NDMA at the trace levels observed overseas are considered very low.

The TGA has required all Australian sponsors of metformin medicines to undertake testing of their products and to report the results to the TGA. The TGA recognises the important role of metformin in managing diabetes in Australia. Therefore, any regulatory action will take into consideration the need to ensure continued availability of metformin in the interest of public health. The TGA will publish updated information, as appropriate, when it becomes available.

Please refer to the following website in TGA for details: http://www.tga.gov.au/alert/metformin

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 the 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 9 Dec 2019. Letters to inform local healthcare professionals were issued by DH on 6 Dec 2019. DH has contacted HSA for further information regarding the detection of NDMA in metformin products and reply is pending. DH has contacted the certificate holders of all registered metformin products for follow up on the local impact of the issue. 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. 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/Friday, Dec 13, 2019
Issued at HKT 13:00

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