In a Major Turnaround, FDA Now Requires "Low-T" Drug Label Changes & Safety Studies: Warns of Stroke & Heart Attack, Inappropriate Prescribing

FDA characterizes today's Safety Announcement requiring label changes for drugs that treat "low testosterone" merely "an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014." But it is obviously much more.

According to today's announcement,

1. FDA is "requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone."


2. "[FDA is] also requiring manufacturers [ of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products."

This is worlds apart from what the FDA said on January 31, 2014 regarding this issue. It is also worlds apart from what Public Citizen petitioned the FDA to do in February, 2014.

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