Food and Drug Administration officials are warning parents to keep prescription testosterone gel far from children due to its serious side effects.
Testosterone can be good in some instances for adults, but the hormone can cause problems in children such as enlargement of the genital organs, aggressive behavior, early aging of the bones, premature growth of pubic hair, and increased sexual drive.
The agency says both boys and girls are at risk, and has ordered its strongest warning on the products. The so-called “black box” warnings will be included on the labels for Solvay’s AndroGel and Auxilium Pharmaceuticals Inc’s Testim.
The problems can arise from simple situations such as adults not washing their hands well.
Testosterone gel is usually applied to the upper arms or shoulders so adults must cover up to keep kids from accidentally touching a spot that has the medicine on it.
Men use testosterone gel when their bodies no longer make the sex hormone, or who have very low levels of it. Doctors also prescribe it to women to increase sexual drive, although the FDA has not approved that use.
In 2007, U.S. pharmacies dispensed about 1.8 million prescriptions for testosterone gel.
The leading brand, AndroGel, accounted for about three-fourths of the sales.
The required label changes will provide additional information about the risk of secondary exposure and the steps that should be taken to reduce the risk, the FDA said.
“These drugs are approved for an important medical need, but can have serious unintended side effects if not used properly,” Dr. Janet Woodcock, director of the FDA’s drug division, said in a statement. “We must ensure that the adults using them are well-informed about the precautions needed to protect children.”
Only a small fraction of cases in which there is a problem with a drug are reported to the FDA, so there could be many more, but since the beginning of December the agency received reports of eight cases in which children were accidentally exposed to testosterone gels.
The kids ranged in age from nine months to five years. Health officials said overall the symptoms went away once testosterone gel was identified as the cause of the problem.
However, for some kids enlarged sex organs did not return to their appropriate size, and bone age remained somewhat higher than the child’s chronological age.
The agency reported that one child even underwent surgery because the link to testosterone gel was not recognized right away.
Health officials recommend that adults who use testosterone gel wash their hands with warm soap and water after each use and cover their skin after the gel has dried.
Pregnant women, and those who may become pregnant, should avoid any exposure, since it could lead to birth defects.
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