Personal Injury Law

FDA Orders 'Black Box' Warning For Testosterone Gels

By Chrissie Cole

Stronger warnings will be added to two prescription-strength testosterone gel products following several reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person treated with these products.

'Black box' warnings will be added to AndroGel (Solvay) and Testim (Auxilium Pharmaceutical) product labels to provide more information about the risk of secondary exposure (exposing someone other than the patient using the gel).

A black box warning is considered the FDA's most urgent warning and is intended to highlight the dangerous risks associated with a particular drug. The boxed text is displayed more prominently then the text surrounding it and therefore provides a better safety warning to users.

Since December, the agency said it had received eight reports of secondary exposure to testosterone in children ranging in age from nine months to five years. Additional reports of potential secondary exposures are still under review.

Adverse events reported in children included inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior.

Testosterone replacement therapies are used by men who either no longer produce the sex hormone or produce it in very low amounts. Doctors sometimes prescribe it to women to increase sexual drive, although the FDA has not approved that use.

'We must ensure that the adults using these products are well-informed about the risks and precautions needed to protect children from secondary exposure,' Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

The signs and symptoms dissipated in most instances once the gel was identified as the cause. Although there were a few cases in which enlarged genitalia did not fully return to age-appropriate size and bone age remained modestly greater than the child's age.

In 2007, prescriptions for AndroGel and Testim were well over 1.8 million, according to data cited by the FDA.

To minimize the potential for secondary exposure, the FDA advises taking the following precautions:

Adults who use testosterone gel products should wash their hands with soap and water after every application;

Once the gel has dried, adults should cover up the application site with clothing;

Prior to any anticipated skin-to-skin contact, users should wash the application site with soap and water;

Women and children should avoid contact with application sites on the skin of men who use these products; and lastly

Similar, but unapproved products, including those sold online, can result in the same serious adverse effects should be avoided. #

Full post as published by InjuryBoard on May 08, 2009 (boomark / email).