An advisory panel with the U.S. Food and Drug Administration (FDA) voted to impose strict new limitations on Low-T drugs used to treat men with low testosterone. Should the FDA accept the panels recommendations, prescriptions would be limited to patients with serious medical conditions, such as pituitary gland problems.
Only a small minority of the 2.3 million men taking testosterone drugs, such as Androgel or Axiron have pituitary gland problems or other serious medical conditions. The vagueness of the labels left many doctors to interpret the drug as an option for any man with low testosterone, according to the advisory panel.
Panelist DR. Michael Domanski voted for the new restrictions to “rein in the inappropriate advertising and use of these drugs.”
The Panel vote would give the FDA more control over the marketing of the drugs and would allow the agency to draw a more narrow definition of the Low T target market, according to the NY Times.
In June, the FDA instructed manufacturers to update the warning label to list blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE), as potential testosterone side effects.
A number of men claiming they suffered a heart attack or stroke while taking testosterone have filed testosterone lawsuits to seek compensation.
Greg Spizer is a partner of Anapol Weiss and co-chairs the firm's Mass Tort Department. He concentrates his practice on pharmaceutical liability, professional malpractice, products liability and other civil and commercial litigation.