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Testosterone gel potentially dangerous for kids, cautions FDA
by Neka Sehgal - May 8, 2009 - comments
The FDA has warned adults using prescription testosterone gel to be extra careful when in contact with children to avoid causing them serious side effects
Washington, May 7: Reports of the development of premature and inappropriate sex characteristics in young children because of accidental exposure to testosterone gel has prompted the U.S. Food and Drug Administration (FDA) to caution people to be very careful not to spread it on to kids inadvertently.
Testosterone gel is prescribed for men whose bodies no longer make the sex hormone, or who produce it at very low levels.
Side Effects
Involuntary exposure to testosterone gel can result in enlargement of the genital organs, premature development of pubic hair, early aging of bones, increased libido and aggressive behavior in both boys and girls.
Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said, "These drugs are approved for an important medical need, but can have serious, unintended side-effects if not used properly. We must ensure that the adults using them are well-informed about the precautions needed to protect children from secondary exposure."
Precautions urged
Because of the potential dangers involved, the FDA warned yesterday that two testosterone gels, AndroGel and Testim, will now be required to carry a “black box warning”.
Dr. Dianne Murphy, director of the Office of Pediatric Therapeutics at the FDA, said one major cause for concern was that many testosterone gels were being marketed on the internet without official approval and they “may lack proper instructions for use”.
The labels on the gels marketed explicitly instruct that the consumers wash their hands after using the product and cover the treated skin after the gel dries, because the sex hormone can be easily transmitted through skin contact.
Cases reported
In spite of the warning issued, the federal agency had received eight cases by late 2008 of secondary exposure to the hormone gel in children nine months to five years of age.
In most cases the symptoms reverted once the gel was recognized as the reason for the problem. In some cases the distended genitals did not revert to the appropriate size and the bone age remained abnormal.
Dr. Murphy stated that children were especially sensitive to the gels because their ratio of skin surface area to volume or weight is higher than in adults.