Testosterone CVD Safety Review Launched in Europe

Shelley Wood

April 11, 2014

LONDON, UK — Following in the footsteps of regulators over the pond, the European Medicines Agency (EMA) has launched a review of testosterone-containing medicines over concerns of cardiovascular risk[1].

As reported by heartwire , the FDA announced a similar review back in January.

According to the EMA announcement today, the European review was triggered by the Estonian State Agency of Medicines, which raised concerns about a report in PLoS One —the same study cited by the FDA. Both agencies also note a November 2013 paper in JAMA , which, like the PLoS One article, link the use of testosterone to an increased risk of MI.

The US National Institutes of Health is sponsoring the Testosterone Trial in Older Men (known as the T Trial), which has finished enrollment; results are expected next year, but lead investigator on the study Dr Peter J Snyder (University of Pennsylvania) has already warned that the trial, designed to enroll fewer than 800 men (788 is the final number), will only be large enough to detect benefits of testosterone, not risks.

"The European Medicines Agency 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and women) and issue an opinion on whether their marketing authorizations should be maintained, varied, suspended, or withdrawn across the EU," the EMA announcement states.

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