Welcome! We regret to inform you that the Injury Board National News Desk has been discontinued. Feel free to browse around and enjoy our previously published articles, or visit The Injury Blog Network for the latest in personal injury news.

FDA Orders 'Black Box' Warning For Testosterone Gels

Posted by Chrissie Cole
Friday, May 08, 2009 10:23 AM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Testosterone Gel, Protecting Your Family, AndroGel, Testim, Men's Health



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. #

1 Comment

Posted by Marsha
Tuesday, May 12, 2009 11:49 PM EST

Our paper ran a story on this. Here is my response to the article in our paper:

I read with interest the article titled, "FDA: Kid's are at risk from adult's testosterone gel" on the FDA issuing a black box warning on testosterone gel being transferred to children. The article said nothing about it being transferred to their spouses.

What's worse is the article only said if adults don't wash their hands well it could be transferred to children. This is not entirely the case. People need to know that even if the adult using the gel IS washing their hands carefully with soap and water, testosterone can still be transferred to other family members via the hand towel if they are sharing it. This was the unfortunate case for myself.

My husband applied his testosterone gel, then thoroughly washed his hands with soap and water and dried them on a bathroom hand towel. I was using the same hand towel after washing my own hands. Over a period of about two months I began to notice strange symptoms in my own body which included severe hot flashes, severe insomnia resulting in sleeping only three hours a night, mood changes and many other symptoms. I did not understand what was happening until I consulted with a doctor who had me take a saliva hormone test. When the results came back a note was attached that said I was supplementing with testosterone and did not declare it on the requisition form. Normal saliva levels of testosterone are 20-50. I was at 167. After some detective work, we traced the problem to the shared hand towel. It took several months for my body to return to normal once we discovered the problem and I started using a separate hand towel.

Please print this as a warning to men using testosterone gel and their families. It is important that not only should the person using the testosterone gel wash their hands well with soap and water, but they should also use a towel separate from all other members of the family. The warning in the article did not go far enough to protect anyone from the effects of testosterone.

Comments for this article are closed.

About the National News Desk

Our mission is to seek the complete truth and provide a full and fair account of the events and issues that surround personal safety, accident prevention, and injury recovery.  We are committed to serving the public with honesty and integrity in these efforts.

Hurt in an accident? Contact an Injury Board member

Subscribe to Blog Updates

Enter your email address if you would like to receive email notifications when comments are made on this post.

Email address


RSS Feed

Add the National News Desk to your favorite RSS reader

Add to Google Reader Add to myYahoo Add to myMSN Add to Bloglines Add to Newsgator Add to Netvibes Add to Pageflakes