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5mo ago

FDA Panel Urges Looser Testosterone Rules, Including Descheduling and Broader Use

The advice is nonbinding, with any label or scheduling changes dependent on later decisions by both agencies.

Abbott Laboratories' AndroGel testosterone gel is displayed for photograph at a pharmacy in Princeton, Illinois, U.S., on Friday, April 27, 2012. A U.S. appeals court handed the Federal Trade Commission a defeat in its campaign to block so-called pay-for-delay arrangements between brand-name and generic drug makers, ruling a settlement involving a patent on Androgel didn't violate antitrust laws.
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Overview

  • At a Dec. 10 public meeting, a 13-member panel recommended aligning product labels with American Urological Association guidance to treat men with low testosterone plus relevant symptoms, not only those with specific medical causes.
  • Panelists said prostate-related warnings and other contraindications on testosterone labels are not supported by contemporary evidence and should be removed.
  • Members urged the DEA to end testosterone’s Schedule III status, arguing the designation deters prescribing and pushes patients toward unregulated T clinics.
  • The FDA earlier this year removed cardiovascular-risk language from boxed warnings after the TRAVERSE trial and required a warning about increased blood pressure.
  • Experts noted potential benefits for some patients but cautioned about risks including blood clots, elevated blood pressure, and possible suppression of sperm production.