Attorney for Testosterone Therapy Drug Patients Urges FDA to Prevent "Off Label" Use of Medications

Phoenix, Arizona—Phoenix Attorney Jonathan O’Steen has asked the federal Food and Drug Administration (FDA) to take action to prevent off-label use of the testosterone therapy drugs AndroGel, AndroDerm, Axiron, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim, or Testopel.

“Off-label use” is a term that applies to the practice of prescribing a drug for uses, time periods or dosages that have not been approved by the FDA.

In a letter to the FDA dated July 30, 2014, O’Steen wrote that FDA approval of the testosterone medications was limited to “men properly diagnosed with the medical condition hypogonadism.” Instead, O’Steen wrote that “these drugs are widely prescribed ‘off label’ to men who are experiencing only natural age-related reductions in testosterone production.”

O’Steen noted that pharmaceutical company advertising aimed at consumers variously claim that testosterone therapy drugs will produce increased muscle growth, reduced body fat, enhanced energy levels, improved sex drive and performance, and stronger bones.

“Medical research reveals, however, that men who use these drugs are at a substantially increased risk of heart attack, stroke and death,” O’Steen added.

O’Steen requested that the FDA act now to prevent further off label use of testosterone therapy drugs during the pendency of its current investigation.

Resources

Letter from Jonathan V. O’Steen to the U.S. Food and Drug Administration, re: Testosterone Therapy Drugs (July 30, 2014)

Testosterone Products: Drug Safety Communication – FDA Investigating Risk of Cardiovascular Events,U.S. Food and Drug Administration (January 31, 2014)

Global trends in testosterone prescribing, 2000-2011: expanding the spectrum of prescription drug misuse, The Medical Journal of Australia (August 2013)

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