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EU Safety Agency Reviews Testosterone Drug Safety


April 11, 2014 — The European Medicines Agency (EMA), the largest health regulatory agency in the European Union, will investigate the link between testosterone replacement therapy and cardiovascular side effects.

The EMA review of testosterone-containing medicines parallels a similar investigation by the U.S. Food and Drug Administration (FDA).

Health officials are concerned about two recent studies linking testosterone therapy to an increased risk of heart attack, stroke, and death. One study involving 56,000 men in the VA health system found that men over 65 on testosterone were twice as likely to have a heart attack than men who did not use testosterone. Even higher risks were seen for younger men with heart disease.

The EMA has asked manufacturers of testosterone products to provide clinical trial data on cardiovascular risks. Investigators also want marketing information.

The marketing of testosterone therapy is under scrutiny because prescriptions have skyrocketed among men who do not have hypogonadism (low testosterone). Testosterone levels naturally decline with age, and some older men are using it to boost energy, mood, sexual performance, and “pump up” muscles.

However, in most European countries and Australia where direct-to-consumer marketing is banned, sales of testosterone have risen only slightly — according to a study published in Medical Journal of Australia last year.


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