Safety advice on particular drugs or classes of drugs
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| European Union: No consistent evidence of an increased risk of heart problems with testosterone medicines |
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The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) of European Medicines Agency (EMA), a regulatory body representing EU Member States, has agreed by consensus that there is no consistent evidence of an increased risk of heart problems with testosterone medicines in men who lack the hormone (a condition known as hypogonadism). However, the product information is to be updated in line with the most current available evidence on safety, and with warnings that the lack of testosterone should be confirmed by signs and symptoms and laboratory tests before treating men with these medicines.
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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