Testosterone Products Need Post-Market Cardiovascular Trial
This article was originally published in The Pink Sheet Daily
Executive Summary
Labeling updates will also clarify approved uses and warn of possible increased risk of heart attack and stroke; impact on products in development unclear.
You may also be interested in...
Product Liability Suits: Testosterone, Lipitor Grow While Yaz, Pradaxa Settle
2014 saw some big settlements in personal injury suits involving Rx drugs, but it’s unclear whether this is a trend or just situation-specific decision-making, since fierce litigation continues for many other products.
Disease-Awareness Ads Thrive In Regulatory No-Man’s Land
FDA says its hands are tied when it comes to curbing practices such as the testosterone ads its advisory committees have found problematic, but are the agency’s powers really that limited?
The Next Estrogen Or An Off-Label Star: Can FDA Turn Back The Clock On Testosterone?
Testosterone replacement products took a hit after an FDA advisory committee, but even if the agency follows their advice, panelists worried a label change will not curb use in the now infamous “Low-T” population; meanwhile, a vigorous pipeline of new testosterone formulations may be left in limbo.