Show #88, July 2009: Warning on Testosterone Gel Products

Warning on Testosterone Gel Products


FDA will require that two topical testosterone gel products carry a boxed warning stating that children could be inadvertently exposed to testosterone if they contact the gel on the skin of another person, and listing specific recommendations to prevent this. The gels, available only by prescription, are used to treat men who don't produce sufficient testosterone. The products are Testim 1%, which is applied to the shoulders and upper arms, and AndroGel 1%, which can also be applied to the abdomen.

The current labeling does have precautions about exposing children, but FDA continues to receive reports where children have come in contact with the gel on another person's body, with serious effects. Some children have experienced inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, and behavioral changes. In a few cases, some signs did not regress when the exposure to testosterone stopped.

To minimize the possibility of exposing children to the gel, FDA recommends that users wash their hands with soap and water after every application. They should cover the site with clothing after the gel dries. And they should wash the application site with soap and water before any skin-to-skin contact with another person. As a further precaution, children and women should avoid contact with application sites on the skin of men who use these products.

FDA is requiring the gel manufacturers to develop a Medication Guide that will describe these risks. It will be given to patients each time their prescriptions are dispensed.


Additional Information:
FDA MedWatch Safety Alert. Testosterone gel products (AndroGel 1% and Testim 1%). May 7, 2009.