Safety advice on particular drugs or classes of drugs
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| European Union: PRAC review does not confirm increase in heart problems with testosterone medicines |
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The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed an EU-wide review of testosterone-containing medicines following concerns over serious side effects on the heart and blood vessels, including heart attack. The PRAC review did not find consistent evidence that the use of testosterone in men who do not produce enough testosterone (a condition known as hypogonadism) increases the risk of heart problems. The committee considered that the benefits of testosterone continue to outweigh its risks but recommended that testosterone-containing medicines should only be used where lack of testosterone has been confirmed by signs and symptoms as well as laboratory tests.
The evidence about the risks of serious side effects on the heart of these medicines is inconsistent. While some studies including three recently published studies did suggest an increased risk of heart problems in men using testosterone compared with men not taking it, these studies had some limitations and others did not confirm this risk. The PRAC also noted that the lack of testosterone itself could increase the risk of heart problems. The PRAC therefore recommended that testosterone-containing medicines should only be used if the lack of testosterone has been confirmed by signs and symptoms as well as laboratory tests. The EU product information for all testosterone-containing medicines should be updated to include this recommendation as well as warnings against use in men suffering from severe heart, liver or kidney problems. The limited data on safety and effectiveness in patients over 65 years of age as well as the fact that testosterone levels decrease with age and that age-specific testosterone reference values do not exist will be highlighted in the product information.
The safety of testosterone medicines should continue to be monitored. In particular, a number of studies are still ongoing and their results will be considered in future regular benefit-risk assessments for these medicines.
The PRAC recommendation will now be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) which will adopt a final position.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002187.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 and 12 April 2014 respectively. 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 urged them to report adverse drug reactions related to the drugs were issued on 20 June 2014 and 16 July 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 Committee, and DH will issue letter to inform local healthcare professionals on the latest EU PRAC recommendations of the products, and will continue to keep vigilant on further announcements on the products issued by other overseas health authorities.
Ends/ Saturday, October 11, 2014
Issued at HKT 14:15
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