EMA: PRAC review does not confirm increase in heart problems with testosterone medicines
Committee recommends medicines can continue to be given for their authorised uses
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.
Posted on the EMA website on 10 October 2014