European Officials Recommend Limited Use of Testosterone Therapies

Monday, October 27, 2014

The European Medicines Agency, or EMA, came out this week in support of testosterone replacement therapy (TRT) drugs, but recommended they only be used in limited circumstances by those who actually need them.

The agency indicated the benefits of TRT drugs still outweigh the risks, but stated patients should be tested for hypogonadism, or low testosterone levels, before they are prescribed.

The agency’s support of TRT meds is in contrast to recent actions taken by the FDA here in the United States, amid mounting data showing the drugs may contribute to heart attacks, cardiovascular disease, strokes and even death.

This year, a UCLA report found men with heart disease may face twice the risk of heart attacks while on testosterone therapies. Prior to that, the AMA warned men over 65 taking testosterone drugs might have a 30% higher risk of heart attack, stroke or death.

In July, an FDA advisory panel recommended new label warnings for the drugs, which now sell over $2 billion per year. Brands like AndroGel, Axiron, Testim and AndroDerm have led aggressive promotions leading millions of men to seek TRT treatment for common signs of aging.

Already, more than 230 men have filed cases against the manufacturers in a central federal court designated just for testosterone lawsuits, alleging the companies didn’t warn of the cardiovascular risks in their rush to increase sales.

The recent EMA recommendation came after a European Union-wide analysis of male patient records by the Pharmacovigilance Risk Assessment Committee (PRAC). In it, they found that current evidence showing a risk for heart issues is inconsistent. The also raised the possibility that the heart risks were due to low testosterone levels alone.

However, the PRAC recommended that continued studies be conducted to monitor the safety of these medications given their widespread use. They also urged doctors to only prescribe them after identifying direct symptoms of hypogonadism, confirmed by laboratory tests.

DrugNews will continue to monitor the ongoing studies related to testosterone safety, as well as the lawsuits against AndroGel, Testim and Axiron advancing through federal court.

Sources:

EMA. PRAC Review Does Not Confirm Increase In Heart Problems With Testosterone Medicines. (October 10, 2014). Retrieved from http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Testosterone_31/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee/WC500175213.pdf

JPML. Pending Multidistrict Litigation. (October 15, 2014). Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-October-15-2014.pdf

 

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