Drug Safety Developments

FDA committee to discuss adverse effects of testosterone products

Quoted from http://www.reuters.com/article/2014/07/17/us-fda-drugsafety-idUSKBN0FM2G320140717

FDA committee to discuss adverse effects of testosterone products

Thu Jul 17, 2014

(Reuters) - The U.S. Food and Drug Administration has called an advisory committee meeting on Sept. 17, to discuss the adverse cardiovascular outcomes with the usage of testosterone replacement therapy.

The FDA has called for a joint meeting of the bone, reproductive and urologic drugs advisory committee and the drug safety and risk management advisory committee. (1.usa.gov/1nPA7Qf)

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Heart Warnings for Low T Drugs? Health Canada Says ‘Yes,’ but FDA Isn’t Sure

Quoted from http://blogs.wsj.com/pharmalot/2014/07/17/heart-warnings-for-low-t-drugs-health-canada-says-yes-but-fda-isnt-sure/

Heart Warnings for Low T Drugs? Health Canada Says ‘Yes,’ but FDA Isn’t Sure

• July 17, 2014

• By Ed Silverman

File this under ‘a study in contrasts.’

Within 24 hours, two regulatory agencies took notably different positions on the virtues of low testosterone medications. Although widely touted for boosting male sex drive, moods and energy, they have also been controversial because some studies found the medicines may pose cardiovascular risks.

Yesterday, Health Canada asked drug makers to update product labeling after a review “found a growing body of evidence from published literature and case reports… for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate.”

This morning, the FDA reserved judgment. In response to a Citizen’s Petition from a consumer advocacy group, the agency rejected the idea of adding a so-called Black Box warning – which is placed on product labeling for the most serious health risks – and also requiring drug makers to send notices to physicians and upgrade patient medication guides to include information about cardiovascular risks.

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