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Published: Oct 13, 2014
By Kristina Fiore, Staff Writer, MedPage Today
A European Medicines Agency (EMA) review committee has concluded that there’s no consistent evidence that testosterone increases the risk of heart problems in men with hypogonadism.
The agency’s Pharmacovigilance Risk Assessment Committee (PRAC) said the drug’s benefits outweigh its risks but warned that it should only be used in patients with confirmed hypogonadism.
The decision follows an FDA advisory committee meeting last month that called for a tightening of label indications and renewed efforts to curb off-label use.
European regulators decided that the evidence about testosterone’s risks and benefits is inconsistent. Several studies have shown an increased risk of heart problems, while others did not, the agency said in a press release.
A group of American endocrinologists has called for one of those papers, published in theJournal of the American Medical Association, to be retracted.
PRAC recommended that testosterone only be used if hypogonadism has been confirmed by symptoms and laboratory testing — and this should be added to the European product information for all testosterone-containing drugs, the group said.
Label information should also include warnings against the drug’s use in men who have heart, liver, or kidney problems, as well as the fact that there are limited data on safety and efficacy in patients over 65, PRAC said.
Although the group acknowledged that a lack of testosterone could increase the risk of heart problems, it still called for further investigation and monitoring of the safety of testosterone drugs.
EMA launched its review of testosterone products in April. PRAC’s recommendations will now go to the Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) for a final position.
The FDA has not yet given a final ruling on its testosterone review, which began in January.In June, the agency issued a warning that testosterone products could cause venous thromboembolism (VTE), but it said this action was not related to the review.
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