A U.S. Food and Drug Administration (FDA) advisory panel voted overwhelmingly to impose new restrictions on testosterone drugs. The Panelists recommended on September 14th that the agency tighten labels and limit testosterone drugs to men with serious health conditions, such as pituitary gland problems.
More than 2.3 million men are taking testosterone drugs, but only a small percentage is treating a serious medical condition, according to the FDA. The majority of men taking testosterone drugs to treat low testosterone (Low-T) are treating symptoms brought on by aging, such as low energy and libido. Medical experts believe this alarming pattern is due to vague labeling, reported the New York Times.
If the FDA adopts the panels recommendations, the agency would not only tighten the criteria for Low-T prescriptions but would also clamp down on what panelists believe to be inappropriate marketing.