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Testosterone Products Need Post-Market Cardiovascular Trial

Labeling updates will also clarify approved uses and warn of possible increased risk of heart attack and stroke; impact on products in development unclear.

FDA is encouraging testosterone sponsors to work together on a single clinical trial to address whether the drugs cause an increased risk of heart attack or stroke; however, sponsors may elect to work on the new post-marketing requirement alone.

Information about a possible increased risk of heart attacks and stroke in patient taking testosterone also needs to be added...

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