FDA Panel Advises Strict Limits on Testosterone Prescriptions

FDA Warning sign

Assuming the FDA adopts the advice of the panel, the drug companies will be forced to severely alter marketing strategies and the number of men prescribed these drugs will be significantly reduced. The recommendations might also impact insurance coverage of testosterone prescriptions.

On June 19, 2014 the FDA announced that labels for these drugs are now required to include warnings pertaining to the risk of blood clots.

Questions remain concerning the long-term risks of testosterone and prior studies have linked the medication to increased rates of heart disease. The same panel  voted 20 – 1 for the FDA  to require further studies be conducted related to cardiovascular risk and testosterone use. On Thursday, September 18th, the panel voted 18 – 3 against the approval of the oral testosterone drug Rextoro; the panel concluded that the risk-benefit ratio fails to support FDA approval.

Advertisements