其他安全警示

The United States: Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the US (English only)

The US Food and Drug Administration (FDA) announces that it has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs. Over the past year and a half, several drug products including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA). During this time, there has been an ongoing investigation into the presence of nitrosamines in other drug products.

The FDA is aware that some metformin diabetes medicines in other countries were reported to have low levels of NDMA. Based on the information FDA has available, the levels of NDMA seen outside the US are within the range that is naturally occurring in some foods and in water. While FDA is aware that some regulatory agencies outside the US may be recalling some metformin drugs, there are no metformin recalls affecting the US market at this time. The FDA is investigating whether metformin in the US market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms. The agency will also work with companies to test samples of metformin sold in the US and will recommend recalls as appropriate if high levels of NDMA are found. If as part of FDA's investigation, metformin drugs are recalled, the FDA will provide timely updates to patients and health care professionals.

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 professional. The FDA recommends prescribers continue to use metformin when clinically appropriate, as the FDA investigation is still ongoing, and there are no alternative medications that treat this condition in the same way.

NDMA is a common contaminant found in water and foods including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of NDMA. The FDA and the international scientific community do not expect it to cause harm when ingested at low levels. The acceptable daily intake limit for NDMA in the US is 96 nanograms. Genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer.

The FDA will continue to investigate the source of these impurities, but it is important to note that there are multiple reasons why NDMA can be present in drugs. Previously, FDA found the source of NDMA can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged. As food and drugs are processed in the body, nitrosamines, including NDMA, can be formed. The FDA continues to test and research possible sources for the several drugs found to contain NDMA.

Please refer to the following website in FDA for details: http://www.fda.gov/news-events/press-announcements/statement-janet-woodcock-md-director-fdas-center-drug-evaluation-and-research-impurities-found

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.

Related news on the detection of N-nitrosodimethylamine (NDMA) in metformin products was previously issued by Singapore Health Sciences Authority (HSA), and was posted on the Drug Office website on 5 Dec 2019. Letters to inform local healthcare professionals will be issued. 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/ Friday, Dec 6, 2019
Issued at HKT 16:00

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