EU Final Position: Little Evidence for Testosterone Harm

Miriam E Tucker

November 21, 2014

A regulatory body representing European Union member states has confirmed it believes there is little consistent evidence of an increased risk for cardiac problems in men who receive testosterone products to treat hypogonadism.

But as stated last month by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), the product label will still be revised to include recent information and warnings.

The Coordination Group for Mutual Recognition and Decentralized Procedures – human (CMDh), a body that examines questions related to marketing authorization of medicines in two or more member states, issued its final position on testosterone today.

"Taking all the data into account, the signal for an increased cardiovascular risk associated with the use of testosterone remains weak and inconclusive," according to an EMA statement.

The PRAC recommended that the testosterone product label be updated to reflect the latest data and to provide warnings about patients who might be at increased risk for cardiovascular events.

Caution is also advised in those with preexisting hypertension, since testosterone can further increase blood pressure.

The revised label will also say that testosterone-replacement therapy should be given only to men in whom the deficiency has been confirmed by clinical features and biochemical tests. Testosterone levels should be monitored regularly during treatment, along with hemoglobin, hematocrit, liver function, and blood lipid profiles.

The label will also caution that there is limited information about safety and efficacy of testosterone products in men over 65 years of age. Physiological testosterone levels decrease somewhat with age, but there is no current consensus on age-appropriate reference values.

Use of testosterone products to boost levels in healthy older men is not an authorized use in the European Union.

In September, a US Food and Drug Administration advisory panel voted nearly unanimously to change the labeling for testosterone-replacement products, with the aim of tamping down on the widespread use for "age-related" hypogonadism there. The panel also indicated that large studies are needed to demonstrate both clinical benefit and safety of the products.

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