European Regulators Reviewing Testosterone SafetyApril 11, 2014 — The European Medicines Agency (EMA) has launched a review of testosterone replacement therapy after several studies found higher rates of heart attack, stroke, and death. The U.S. Food and Drug Administration (FDA) launched a similar investigation last month.

The EMA review of testosterone-containing medicines was prompted by two studies linking testosterone and heart risks. One study involving 56,000 men found that men over 65 were twice as likely to have a heart attack compared to men not on testosterone. Even higher risks were seen in younger men with heart disease.

The EMA asked drug-makers to provide detailed analysis of data from clinical trials on cardiovascular risks, as well as marketing information. The agency will study the risks and benefits and decide whether to restrict access to the drugs in the European Union.

Testosterone replacement patches, gels, implants, injections, and other products are approved for men with hypogonadism (low testosterone) due to a medical condition. It is not approved for older men who are healthy. However, testosterone is increasingly being prescribed by doctors or purchased online by older men who are looking to boost energy, improve sexual performance, or “pump up” sagging muscles. Testosterone declines naturally with age.

In the last decade, prescriptions have skyrocketed in the United States. In European countries where direct-to-consumer marketing is banned, testosterone sales growth has been far less dramatic, according to a study published in 2013 by the Medical Journal of Australia.

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