有 关 个 别 药 物 或 某 类 别 药 物 的 安 全 资 讯
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| 欧洲联盟: 没有一致的证据显示睾酮产品可增加心脏问题的风险 |
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在香港，共有八种注册药剂制品含有睾酮，并均属医生处方药物。卫生署注意到美国食品及药物管理局及欧洲药物监管局已展开有关睾酮产品可导致心血管疾病风险的检讨，并有待美国食品及药物管理局的结论，而相关消息已分别在2014年2月4日、4月12日及2014年10月11日被刊登于药物办公室的网页。美国食品及药物管理局亦已公布有关产品可导致静脉血栓栓塞症的消息，而此资讯已在2014年6月20日被刊登于药物办公室的网页。与此同时，加拿大卫生部已完成了睾酮产品可导致心血管问题的安全评估，并正与制造商一起更新产品的标签以包含相关的安全警示，而有关消息已在2014年7月16日被刊登于药物办公室的网页。卫生署已于2014年6月20日、2014年7月16日及2014年10月13日就上述的安全警示及欧盟药物警戒风险评估委员会提出的最新建议发信通知医护专业人员，并促请他们呈报与该药物有关的任何不良药物反应。至今，卫生署未接获与使用该药物相关的心血管并发症的不良反应报告。鉴于欧盟、美国及加拿大的药物监管局公布的消息，有关事宜将于药剂业及毒药管理局注册委员会的会议上讨论，卫生署并将继续监察其他海外药物监管局发布有关该等产品的进一步消息。
详情请浏览以下英文版网址：
http://www.drugoffice.gov.hk/eps/news/../24107.html
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2014年11月22日(星期六)
香港时间13时正
The CMDh position follows a review by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) which looked at the risk of serious problems affecting the heart and circulation, particularly heart attacks, in men treated with these medicines. The review was started because of some recent studies suggesting an increase in heart problems in men using testosterone, compared with men not using it. The PRAC considered these studies along with available data from other studies and analyses, and information on safety collected since marketing, and found that the evidence regarding the risk of heart problems was inconsistent: some studies suggested increased risk, while others did not, and some of the studies had problems with the design that limited the conclusions that could be drawn from them. The PRAC also noted that the lack of testosterone itself could increase the risk of heart problems.
The PRAC recommended updating the product information in line with the latest evidence and to provide warnings about those who might be at increased risk of heart problems. The product information should make it clear that testosterone should only be used when an abnormally low level of the hormone has been confirmed by signs and symptoms and appropriate laboratory tests. Testosterone levels naturally fall somewhat with age, but restoration of these levels in healthy older men is not an authorised use of the medicine in the EU. The PRAC further considered that the risks of effects on the heart and circulation, and any potential mechanisms for such effects should continue to be monitored, and information from ongoing studies should be provided as part of the next regular safety review.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002218.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are eight registered pharmaceutical products containing testosterone and they are prescription-only medicines. DH noted that the US FDA and EMA have started to review the risk of cardiovascular events of testosterone products and conclusions from the US FDA are pending, and the related news was posted on the Drug Office website on 4 February 2014, 12 April 2014 and 11 October 2014. Related news on the risk of venous thromboembolism was also released by the US FDA previously, and was posted on the Drug Office website on 20 June 2014. Meanwhile, Health Canada has completed a safety review on the possible cardiovascular problems with testosterone products, and is working with their manufacturers to update the Canadian product labels with the safety warnings, and the news was posted on the Drug Office website on 16 July 2014. Letters to inform local healthcare professionals on the above safety warnings and the latest EU PRAC recommendations were issued on 20 June 2014, 16 July 2014 and 13 October 2014. So far, DH has not received any adverse drug reaction report on the drug related to cardiovascular complications. In light of the above announcements by the EU, US and Canada health authorities, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board, and will continue to keep vigilant on further announcements on the products issued by other overseas health authorities.
Ends/Saturday, 22 November, 2014
Issued at HKT 13:00
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