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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Androgel 2009 Label Update Warns about Children who Come in Contact

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With the development of premature and inappropriate sex characteristics in children exposed to testerone boosting products, the U.S Food and Drug Administration (FDA) is requiring further warning labels on topical gels to limit exposure. Children are usually exposed inadvertenly, through contract with a parent or other individual who has been treated with the product. Although warning labels are a good step, many are still unaware of the dangers of exposure, and the potential risks our children face when coming into contact with these products.

AndroGel and Testim, two testosterone gels approved for use by men, have been prescribed to millions of patients world wide. Users of the gel likely expose the substance to children or unapproved individuals by forgetting to wash their hands after touching treated areas, not waiting for skin to dry before coming into contact with others, or picking up a child and initiating contact between the patient’s upper body and the child.

As children have a smaller total body size than adults, their skin surface area is much more concentrated, allowing for the effects of the gel to become more pronounced in exposed individuals. Children from as young as nine months, to five years old, who have suffered from exposure to the gel now show symptoms of enlargement of the genitalia, premature public hair development, advanced bone age, and increased libido.

To prevent exposure the FDA recommends that women and children avoid contact with the areas that men have applied the product, and for men who use the product to perform the following procedures during use:

– Wash hands with soap and water after application

– Cover application site until dry

– Wash application site before coming into contact with another individual.

If you or someone you know has been using topical testosterone gel, it is important that you take all necessary precautions before interacting with women or children, as neither have been approved for contact with the gels by the FDA.