EMA to conduct major review into testosterone drugs

pharmafile | April 14, 2014 | News story | Research and Development, Sales and Marketing |  EMA, EU, Europe, heart, testosterone 

The European Medicines Agency has started a review of testosterone-containing medicines as concerns grow that they may increase the risk of heart attacks.

The review was triggered by the Estonian medicines agency following the recent publication of a study suggesting that the use of testosterone increases the risk of myocardial infarction (heart attack) – in men aged over 65 years.

It also showed there may be an increased risk in younger men with pre-existing heart disease.

This study follows other reports including the Veterans Health Care Study, which suggests that men with pre-existing heart disease who received treatment with testosterone had a higher risk of heart problems, compared to men who did not receive testosterone.

These medicines are generally used by men who do not produce enough testosterone, a condition known as hypogonadism.

The EMA says it will now review all available data on the benefit-risk balance of testosterone-containing medicines (in men and women), and issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.

Testosterone drugs have been approved in several EU countries under various trade names and are sold as capsules, implants for under the skin, patches or gels.

The medicines may also be taken by women to manage menopause symptoms. Using the products in healthy, older men isn’t a permitted use in the EU, the agency adds.

Testosterone is a natural hormone, known as an androgen, found in men and women. In men with hypogonadism, testosterone levels are abnormally low affecting normal sexual development.

Testosterone-containing medicines work by replacing the missing testosterone, helping to restore normal testosterone levels to ensure normal sexual development in men.

Ben Adams