The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), 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 (to which these medicines, like all medicines in the EU, are subject).

The CMDh has endorsed the PRAC recommendations by consensus and they will now be directly implemented according to an agreed timetable by the Member States where the medicines are authorised.


Posted on the EMA website on 21 November 2014