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THE EUROPEAN MEDICINES AGENCY INITIATES REVIEW OF TESTOSTERONE PRODUCTS OVER CONCERNS ABOUT CARDIAC SIDE EFFECTS

THE EUROPEAN MEDICINES AGENCY INITIATES REVIEW OF TESTOSTERONE PRODUCTS OVER CONCERNS ABOUT CARDIAC SIDE EFFECTS

The European Medicines Agency (EMA) recently started a safety review of testosterone-containing products. The review was initiated at the request of the Estonian medicines agency due to concerns about harmful effects of testosterone therapy (TT) on the heart. These safety issues were raised in several recent publications that suggested significantly increased risk of heart attacks and other cardiac problems in men receiving TT.

EMA will analyze "all available data on the benefit-risk balance of testosterone-containing medicines" and decide whether the marketing authorizations for testosterone products "should be maintained, varied, suspended or withdrawn across the [European Union]."

Sources:

EMA,

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/04/news_detail_002069.jsp&mid=WC0b01ac058004d5c1

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Testosterone-containing_medicines/human_referral_prac_000037.jsp&mid=WC0b01ac05805c516f

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