EMA’s PRAC: no increased risk of heart problems with testosterone medicines
European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) review does not confirm increase in heart problems with testosterone medicines. An EU-wide review of testosterone-containing medicines was performed following concerns over serious side effects on the heart and vessels, including heart attack. Testosterone-containing medicines are used to replace testosterone in men with hypogonadism. The use of testosterone in healthy older men is not an authorised use in the EU.
The PRAC review did not find consistent evidence that the use of testosterone in men who do not produce enough testosterone 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 hypogonadism has been confirmed by signs and symptoms as well as laboratory tests.
While some studies did suggest an increased risk of heart problems in men using testosterone, as compared with men not taking it, these studies suffered from some limitations. Other studies did not confirm this increased risk.
The PRAC also noted that the lack of testosterone itself could increase the risk of heart problems. It is therefore recommended that testosterone-containing medicines should only be used if a testosterone deficit has been confirmed clinically and by laboratory tests.
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 disease. Furthermore, it will be highlighted that there is limited data on safety and efficacy in patients over 65 years of age, and that testosterone levels decrease with age and that age-specific testosterone reference values do not exist.
The safety of testosterone medicines should continue to be monitored. Several studies are ongoing and will provide results for future regular benefit-risk assessments for these medicines.
This PRAC recommendation will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a final position.
EMA Press release 10 October 2014