其 他 安 全 警 示
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| Singapore: Update on nitrosamine impurity in sitagliptin products (English only) |
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Health Sciences Authority (HSA) announces that a new nitrosamine impurity, Nitroso-STG-19 (also known as NTTP), has recently been detected in trace amounts in sitagliptin products by the manufacturer. These levels were higher than the internationally acceptable limit in only certain samples of the products.
A very conservative approach is used internationally to set limits for nitrosamine impurities in medicines. The acceptable limits are determined based on what is considered reasonably safe if a patient takes the affected medicine every day for a lifetime of 70 years. Therefore, although the trace amounts of NTTP detected were above the international acceptable limit, HSA has assessed that the risk to patients taking the affected sitagliptin medicines is very low.
The company will be making the necessary changes in the manufacturing processes to eliminate or reduce the amount of the impurity to stipulated levels. In the interim period, in consideration of the benefits of the medicines versus the potential risks, HSA is temporarily allowing a higher limit of NTTP in sitagliptin products so that patients can have continued access to these medicines. HSA has assessed that taking the affected sitagliptin medicines containing NTTP at the higher interim limit for an additional short-term exposure during the interim period presents minimal additional risk to patients. While there are other anti-diabetic medicines available, switching patients from sitagliptin to alternative medicines could potentially result in disruption in diabetes control in patients. This could pose greater health risks to patients compared to the low risk of taking the affected products. Patients taking sitagliptin medicines are advised not to stop taking these medicines on their own as sudden stoppage in the use of the medicines can raise blood sugar levels. This approach of HSA’s is consistent with those taken by other regulatory authorities.
HSA is working closely with international regulatory agencies and the company supplying these medicines to implement measures to eliminate or reduce the amount of the impurity to acceptable levels.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/safety-alert/update-on-nitrosamine-impurity-in-sitagliptin-products
In Hong Kong, there are 12 registered pharmaceutical products containing sitagliptin. All products are registered by Merck Sharp & Dohme (Asia) Ltd (MSD). They are prescription-only medicines. So far, the Department of Health (DH) has received 9 cases of adverse drug reaction related to sitagliptin. None of them is concluded to be related to the presence of NTTP.
Related news was previously issued by Australia Therapeutic Goods Administration, and was posted on the Drug Office website on 17 Sep 2022.
The DH has contacted MSD to follow up on the impact of the local marketed products and to provide evidence that NTTP in the products are below acceptance limit. 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 sitagliptin-containing products should not stop taking the medicines unless advised by their prescribers.
Ends/Thursday, Nov 3, 2022
Issued at HKT 15:00
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