FDA Requires Label Changes for Testosterone Gels
Yesterday, the U.S. Food and Drug Administration (FDA) announced the requirement of boxed warnings to topical testosterone gel products due to safety concerns. The two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, have bee connected to adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).
Both testosterone gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both gels are used by applying to the shoulder or upper arm skin once daily. AndroGel 1% may also be used by applying to the abdominal skin. Precautions in the current labels instruct users to wash their hands after using the product and to cover the treated skin with clothing.
With 1.4 million prescriptions for AndroGel and 370,000 prescriptions for Testim dispensed in 2007, if the current or new labeled precautions aren’t followed there is great risk for secondary exposure of the testosterone to children. As of Dec. 1, 2008, the FDA had received reports of eight cases of secondary exposure to testosterone in children ranging in age from nine months to five years. Since that time, additional reports of secondary exposure have been received by the agency and are presently under review.
When infants and young children are exposed to testosterone, there can be inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior.
In most cases, these signs and symptoms regressed when the child is no longer exposed to the testosterone source. However, in a few cases, enlarged genitalia did not fully return to age-appropriate size and bone age remained modestly greater than the child’s chronological age.
In many cases, children had to undergo invasive diagnostic procedures. Signs of inappropriate virilization (development of male secondary sexual characteristics) in children and the possibility of secondary testosterone exposure should be brought to a health care provider’s attention.
The labeling states that treated areas should be covered with clothing and that hands should be thoroughly washed with soap and water after application. The new warning will highlight these directions.
The FDA recommends the following precautions be taken to minimize the potential for secondary exposure:
* Adults who use testosterone gels should wash their hands with soap and warm water after every application;
* Adults should cover the application site with clothing once the gel has dried;
* Adults should wash the application site thoroughly with soap and warm water prior to any situation where skin-to-skin contact with another person is anticipated;
* Children and women should avoid contact with testosterone application sites on the skin of men who use these products; and
* Adults should note that use of any similar, but unapproved, products from the marketplace –including the Internet– that can result in the same serious adverse effects should be avoided.
Any adverse events associated with testosterone gels or other drugs should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
FDA News Release