FDA Orders Strict Warnings on Dangers of Testerone Gel That Can Come in Contact With Children

If you or another adult in your household use testosterone gel, the FDA is urging extra care not to get any of the medication on children. Contact can cause both boys and girls serious side effects including enlargement of the genital organs, aggressive behavior, early aging of the bones, premature growth of pubic hair, and increased sexual drive.

To emphasize their concern, the agency ordered its strongest warning on the products — a so-called black box.

If you use this product, be sure to wash your hands with soap and water after application. Also, be sure to cover up the areas that the gel has been applied (very commonly the upper arms and shoulders) to keep kids from accidentally touching a spot that has the medicine on it.

Health officials said in most cases the signs and symptoms went away once testosterone gel was identified as the cause of the problem and adults took the proper precautions. But in some children, enlarged sex organs did not return to their appropriate size, and bone age remained somewhat higher than the child’s chronological age. One child underwent surgery because the link to testosterone gel was not recognized right away.

Also, pregnant women, and those who may become pregnant, should avoid any exposure, since it could lead to birth defects.

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