Testosterone Drugs Under Review by EU Regulator

Testosterone medicines are being reviewed by the European Unions drug regulator after studies suggested the products may pose risks to the heart.

The European Medicines Agency will study the products benefits and risks to issue an opinion whether their marketing authorizations should be maintained, changed, suspended or withdrawn across the 28-nation bloc. The drugs are mainly used by men who dont produce enough of the sex hormone, the agency said today in a statement.

One study suggested that using testosterone increases the risk of a heart attack in men older than 65, as well as in younger men with heart disease, the agency said. Other trials have raised similar concerns, the EMA said. In January, the U.S. Food and Drug Administration said it was looking over data on testosterone drugs because of potential harm to the heart.

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 isnt a permitted use in the EU, the agency said.

Patients should speak to their doctors or pharmacists if they have concerns about testosterone products, the EMA said.

To contact the reporter on this story: Kristen Hallam in London at khallam@bloomberg.net

To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net Thomas Mulier, Bruce Rule

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Testosterone Drugs Under Review by EU Regulator

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