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FEBRUARY 2014

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Testosterone Gel Safety Concerns Prompt Label Changes

Gordon Gibb

January 25, 2014 (LawyersAndSettlements.com) Washington, DC: While it has been a few years since the US Food and Drug Administration (FDA) mandated significant label changes for the two most-used testosterone gel products, the risks associated with the products do not rank high on the public consciousness. And as testosterone gels are heavily promoted to the older, male demographic - and the products are indicated for use in men - a lack of similar testosterone therapy for women have prompted some doctors to advocate the use of such gels by women in certain situations, thereby exacerbating the risks.

The testosterone gel safety concerns that prompted the label changes are founded in the potential for adverse reactions experienced by children when they inadvertently come into contact with the products after they have been used by a parent or caregiver. “The US Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels,” the agency said on March 2, 2010.

“The agency is requiring this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).”

As you have read here, the adverse reactions have included unnatural enlargement of genetalia, premature growth of pubic hair and aggressive behavior, amongst other concerns. The use of these gels, in a parental setting, needs to be carefully managed in order to mitigate potential exposure to children.

However, this is easier said than done given the popularity of testosterone gels amongst men. Doctors, for the most part, agree that for men with serious testosterone deficiency (symptoms include low libido, extreme lethargy and lack of energy, inability to focus, et al) testosterone therapy can be helpful. However in recent years, testosterone therapy - including the popular testosterone gels - has been heavily marketed to men who may not be in dire need of testosterone therapy. Otherwise healthy men watching football games or listening to sports talk shows on radio are invited to “man it up” with testosterone gels, and various online sites carry questionnaires whereby men can, or so it is claimed, self-diagnose their potential need for such products.

To that point, the New York Times (11/24/13) referenced a recent study published in JAMA Internal Medicine that suggests about 25 percent of men having received prescriptions for testosterone gel had not undertaken blood tests to check testosterone levels. “A lot of these men don’t have clear, unequivocal indications for this drug,” said Dr. Jacques G. Baillargeon of the University of Texas, the lead author of the study, in comments published in the New York Times, “and yet you see the aggressive advertising on ESPN, on radio, on the Internet.”

Increased use of testosterone gels in such a recreational context, as opposed to necessary medical intervention, can potentially expose more children in kind as the use of these gels increase in popularity.

And now there is a new wrinkle: some doctors are advocating, in the absence of testosterone therapy for women, the use of testosterone gels to combat low libido that is often a byproduct of menopause.

The Irish Daily Mail (12/17/13) reports that Hormone Replacement Therapy (HRT) is commonly used to treat the hot flashes and other symptoms of menopause. However, HRT does little to counteract a flagging libido.

Angie MacDonald is a journalist and blogger who suffered from ovarian failure in her 30s. The symptoms can be akin to those associated with early onset menopause. Her gynecologist put MacDonald on combined HRT - but also suggested the application of a testosterone gel to her stomach once per day. Blood tests had revealed MacDonald also suffered from very low levels of testosterone.

Applying tiny spots of gel to her tummy daily seemed to produce the desired effect. MacDonald described feeling energized and alive. But then she discovered her belly was growing hair from the topical gel. Alternating the application sites to also include thighs and upper arms took care of the hair growth problem.

However, MacDonald’s experience highlights how the gels can negatively impact children who come into contact with the gels. MacDonald also noted that application of the gel “is obviously a hit-and-miss business, with no standard dose so you just have to guess the correct measurement,” she said in comments published in the Irish Daily Mail.

It should be noted that drug manufacturers are not allowed to promote or market a product for any indication other than that which is approved by the FDA. However, doctors have the authority to circumvent those restrictions for the benefit of their patients.

Thus, MacDonald’s gynecologist recommended a product that is designed and marketed to men.

Given the lack of testosterone replacement products for women who might benefit from testosterone therapy in concert with combined HRT (estrogen and progesterone), the potential for increased use of gels by women, and the already widespread use of testosterone gels by men, may result in increased incidents of adverse reactions in children and grandchildren unless precautions are taken.

Thus the headline “Testosterone Gel Safety Concerns Prompt Label Changes” takes on an increased significance.

 

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