其 他 安 全 警 示
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| Australia: Sitagliptin: Safety advisory - low levels of contamination with a nitrosamine impurity (English only) |
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The Therapeutic Goods Administration (TGA) announces that it is investigating potential contamination of sitagliptin medicines with very low levels of a nitrosamine impurity, known as 7-Nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo-[4,3- a]pyrazine (NTTP).
Sitagliptin is a prescription medicine used to treat type 2 diabetes. It is marketed in Australia under multiple trade names.
The TGA has set an acceptable intake (AI) limit for NTTP of 37 nanograms (ng) per day. Australian sponsors of sitagliptin products have reported that some sitagliptin products in the Australian market contain levels of NTTP that are higher than this limit. This issue also affects sitagliptin products supplied overseas.
To prevent a shortage of sitagliptin, the TGA is temporarily allowing supply of sitagliptin medicines containing NTTP that exceed the AI limit. The TGA has assessed that an intake of up to 246 ng NTTP per day does not pose a health concern based on short-term exposure compared with the risks for patients that cannot access their sitagliptin medicines. The risks of not taking sitagliptin as prescribed, is greater that the risk associated with this impurity.
Consumers are advised to continue to take their sitagliptin medicines as prescribed. Patients should not stop taking their sitagliptin medicines unless instructed to by their health professional.
Nitrosamines are a group of compounds which can damage DNA. They are commonly found in low levels in a variety of foods, including smoked and cured meats, dairy products, vegetables, in some drinking water, and in air pollution. Long-term exposure, over years, can increase an individual's risk of developing cancer.
The additional risk that would be posed by the trace levels of NTTP being detected in sitagliptin is likely to be very low. However, the presence of nitrosamine impurities is generally considered unacceptable for a medicine. The actual health risk depends on the medicine and dose taken and will vary from person to person.
Nitrosamine impurities have also been found in other medicines. They were first identified in 'sartan' medicines in 2018. Medicines affected by nitrosamine impurities in Australia include 'sartan' blood pressure medicines in 2018, metformin and ranitidine products in 2019, varenicline products and rifampicin products in 2021, and quinapril products in 2022.
Health professionals should be aware that NTTP may be present at very low levels in sitagliptin products supplied in Australia. However, there is no reason to stop prescribing sitagliptin as the benefits continue to far outweigh the risk posed by this impurity.
The TGA has reviewed results reported by Australian sponsors of sitagliptin medicines on the ARTG that are available on the market. It continues to work with its international regulatory partners and sitagliptin medicine sponsors to respond to this issue and will determine whether other actions are required.
Please refer to the following website in TGA for details:http://www.tga.gov.au/news/safety-alerts/sitagliptin
In Hong Kong, there are 12 registered pharmaceutical products containing sitagliptin. All products are registered by Merck Sharp & Dohme (Asia) Ltd (MSD), and are prescription-only medicines. So far, the Department of Health (DH) has received 8 cases of adverse drug reaction related to sitagliptin. None of them is concluded to be related to the presence of 7-Nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo-[4,3- a]pyrazine (NTTP). The DH has been contacting MSD to follow up on the impact of the local marketed products; and will remain vigilant on the development of the issue and any safety update of the drugs issued by overseas drug regulatory authorities for consideration of any action deemed necessary.
Patients who are taking sitagliptin-containing products should not stop taking the medicines unless advised by their prescribers.
Ends/ Saturday, Sep 17, 2022
Issued at HKT 12:00
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