New Boxed Warning for Testosterone Gels to Protect Against Secondary Exposure
May 7, 2009 â?? The US Food and Drug Administration (FDA) held a press conference today to announce a change in the labeling of the testosterone gel products AndroGel 1% (Solvay Pharmaceuticals) and Testim 1% (Auxilium Pharmaceuticals). The label is now required to include a boxed warning about the dangers of secondary exposure to children.
The decision to add the boxed warning was a result of reports of adverse events in 8 children as of December 1, 2008, who had been in close contact with users of the products.
The children, ranging in age from 9 months to 5 years, developed "inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior," the FDA release states.
"In most cases, the signs and symptoms regressed when the child no longer was exposed to the product. 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," Diane Murphy, MD, from the Office of Pediatric Therapeutics, Office of the Commissioner, FDA, told Medscape Diabetes & Endocrinology.
"In some cases, children had to undergo invasive diagnostic procedures and, in at least one case, a child was hospitalized and underwent surgery due to a delay in recognizing the underlying cause of the signs and symptoms," FDA officials reported.
Mark Hirsch, MD, medical team leader of urology in the Division of Reproductive and Urologic Products, Center for Drug Evaluation and Research, FDA, said that "the case review has been incomplete, but some of these children were less than a year old...[and] they had rather high levels of testosterone," which were likely a result of direct skin-to-skin contact with areas to which the gel had been applied.
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 boxed warning will include the following:
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 before 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 â?? including from the Internet â?? that can result in the same serious adverse effects should be avoided.
Any adverse events associated with testosterone gels 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.