Black box warning for testosterone gel products

If you’ve ever hoisted a child up and held him in the crook of your arm, you know where his face goes: in your face, nuzzling your neck, and (if you’re lucky) on your shoulder when he finally falls asleep.

But that tender moment could take a very unhealthy turn if the child comes into contact with a testosterone-boosting medication.

Testosterone gel is used to treat the symptoms of andropause–also known as male menopause. For men who find they’re moody, low on energy, lacking sex drive, or experiencing memory loss, testosterone gel raises levels of the hormone, which may restore general vitality.

But fathers and grandfathers who use testosterone gel need to be aware that the medication may cause a “virilization” of children and women who come into contact with the gel.

The FDA now requires the manufacturers of two prescription testosterone gel products–AndroGel 1% and Testim 1%–to include a black box warning with the packaging of their medications.

The warning alerts consumers to the dangers of secondary exposure to the powerful hormone, which is typically spread on the shoulders or upper arms daily.

The FDA reports that several young children have suffered adverse effects when they came into contact with the drug being used by adults. This exposure has caused inappropriate enlargement of genitalia in boys and girls, advanced bone age, aggressive behavior, and other disturbing symptoms in children aged nine months to five years.

Instructions packaged with the drugs clearly state that precautions should be taken so that other people avoid contact with the gel.

In 2007, nearly two million prescriptions were written for testosterone gel products. Most of those prescriptions are filled by men, but some doctors prescribe the gel “off label” for women.

To Your Good Health,

Jenny Thompson

Source:
“Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide” FDA News, 5/7/09, fda.gov