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| Chaffin Luhana LLP

Testosterone therapy continues to make headlines, including more recently after the FDA announced its plans to investigate the risk of heart attack, stroke, or death associated with its use.  But it’s not the first time.  In 2009, the FDA required two manufacturers of prescription testosterone gel products, Androgel 1% and Testim 1% to include a black box warning about “secondary exposure” involving women and children.  The FDA also warns about exposure to Axiron in the drug side effects.  Axiron is a form of testosterone therapy used as a topical solution.

By December 2008, the FDA received reports of 8 cases where children ranging in age from nine months to five years were exposed to testosterone gel products and suffered negative effects.  These included signs of the early onset of puberty including:

• Enlarged clitoris or penis
• Aggressive behavior
• Increased erections, sex drive
• Early development of pubic hair

In most of those cases, these side effects from secondary exposure went away on their own.  In others, the symptoms persisted to the point where the child had to go through “invasive diagnostic procedures” to correct the problem.

If your child suffered or is suffering from any of these symptoms you need to report this to his or her doctor.

Women, Secondary Exposure, and Testosterone Therapy Treatment

The FDA also received reports of adverse effects when women were exposed to testosterone gel products through “secondary exposure.”  They may experience a change in body hair or a noticeable increase in acne.

But, some women are prescribed a form of testosterone therapy when they lack the male hormone, androgen.  Testosterone is not approved by the FDA for treating women, but a doctor may write you a prescription for a “compounded formula” of testosterone.  It is sometimes recommended for menopausal women. This form of testosterone can also cause changes in hair pattern, and an increase in acne.

Preventing Secondary Exposure

In the black box warning on Androgel 1% and Testim 1%, the FDA asks patients who use those products to thoroughly wash their hands if they expect to have skin-to-skin contact with another person.  If anyone else comes into contact with the gel they also need to wash that area right away with soap and water.

FDA Investigates Heart Attack Risk with Testosterone Therapy Treatment

On January 31st, 2014, the FDA announced it was investigating the risk of heart attack, stroke and even death among those patients using a form of testosterone therapy.  This was prompted by two recent studies, one published in the Journal of the American Medical Association (JAMA), and the other in PLOS One.

Never start or stop using any form of testosterone therapy treatment unless directed to do so by your doctor.  If you are suffering from any adverse effects let your physician know and contact the FDA.  You could be entitled to a testosterone therapy lawsuit.

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