European agencies follow FDA lead on T, CV risk

The European Medicines Agency (EMA) has issued new recommendations regarding testosterone replacement therapy (TRT) after reviewing the cardiovascular risks of TRT. The recommendations were endorsed by a regulatory body that is responsible for the marketing authorization of drugs throughout Europe.

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The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), following a review of cardiovascular risks in men taking TRT, said it did not find consistent evidence that the use of TRT increases the risk of cardiovascular events.

However, the committee also recommended that testosterone agents should only be used if lack of testosterone has been confirmed by signs and symptoms as well as laboratory tests. It also recommended an update of EU product information for all testosterone-containing medicines to include this recommendation as well as warnings against its use in men suffering from severe heart, liver, or kidney problems.

In a press release, the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh), a regulatory body representing European Union Member States, said that it endorsed the PRAC recommendations and that they will be directly implemented according to an agreed timetable by the EU Member States where the medicines are authorized.

Among the information provided for health care professionals in the EMA’s statement:

• Although some studies show an increased risk of cardiovascular events in men treated with testosterone, findings in the literature do not show this consistently.

• TRT should only be given when deficiency of the hormone has been confirmed by clinical features and biochemical tests. Testosterone levels should then be monitored regularly during treatment. Hemoglobin, hematocrit, liver function, and blood lipid profile should also be monitored regularly.

• There is limited experience on the safety and efficacy of the use of these medicines in patients over 65 years of age.

The EMA announcement comes after an FDA advisory committee voted in September to restrict indications for TRT and require additional trials to test the safety of the drugs. More recently, researchers from Intermountain Medical Center Heart Institute in Murray, UT, reported that TRT reduced men’s overall risks for death, nonfatal myocardial infarction, and stroke, as well as for death alone.

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