Testosterone cream: bad for babies, FDA warns
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Ask any woman: It was just a matter of time before the FDA would finally come to its senses and warn of the dangers of testosterone. Well, it’s happened ... kind of.
The FDA announced today that it will require a ‘black box warning’ -- its most urgent consumer advisory of potential harm -- on the package insert that comes with two prescription-strength topical testosterone gels, AndroGel and Testim. Effectively, the new information packet is to warn users of the gel -- approved for the treatment of men with testosterone deficiency but also widely used to enhance libido and sexual performance in men and women -- that they should not cradle, hug or provide bareback piggyback rides to babies and children after applying the gel to the arms, shoulders or abdomen, as prescribed.
When children’s skin comes into direct contact with skin to which the gel has been applied, FDA says, they can develop pubic hair, enlarged genitalia, increased libido, premature bone aging and, well, aggressive behavior. FDA said that in spite of existing warnings, by late 2008, it had eight reports concerning children, from 9 months to 5 years old, who suffered such effects after a ‘secondary exposure,’ and more reports have come in since. Mostly, the symptoms disappeared after exposure to the gel was ceased, but in some cases, genital enlargement and advanced bone age persisted.
This black-box warning will appear on the roughly 1.4 million prescriptions of AndroGel and 370,000 prescriptions for Testim that are dispensed legitimately in a year. But you’re unlikely to see it if you are among the myriad buyers of testosterone gel peddled by Internet purveyors and gym rats who promise it will boost your performance in the bedroom, weight room and on the ball field.
So unless you want little Jacob or Emily to start shaving and plotting world dominance while still in preschool, FDA suggests washing your hands carefully after applying the stuff, and covering skin to which it’s applied before playing, cuddling or wrestling with the little tyke.
-- Melissa Healy
