Call Us: 1.800.873.5297


FDA Issues Warning for Serious Effects From Children in Contact with Users of Testosterone Gel

Young children are reportedly developing premature or inappropriate sexual organs from their contact with adult users of testosterone gel. Specifically, young girls developed male sex characteristics, and boys prematurely developed male sex characteristics. The FDA is now requiring two testosterone gel products to have a boxed label warning of these serious side effects.

The gels in question, AndroGel and Testim, are approved for use in men who have extremely low testosterone levels. Women reportedly use testosterone gel to increase libido; this is an off-label, non-FDA approved use of testosterone gel and not recommended. In 2007, there were 1.4 million prescriptions dispensed for AndroGel and just 370,000 for Testim.

AndroGel is manufactured by Solvay of Belgium. Testim is manufactured by Auxilium of Malvern, PA.

Dr. Dianne Murphy, director of the Office of Pediatric Therapeutics at the FDA, suggests that a gel user could have caused the child to come into contact with the gel by forgetting to wash his or her hands or the treated area. Additionally, the gel user may have not waited for skin to dry, and then picked up the child and held him or her.

Children ages 9 months to 5 years are among the eight reported cases the FDA is following. These children suffer from abnormal effects, including inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, increased libido and aggressive behavior.

Most of the children’s signs and symptoms regressed after they were no longer exposed to the gel. However, a few children still have enlarged genitalia and bone ages higher than the child’s chronological age, the FDA said.

One of these children required surgical intervention. Some children also had to undergo invasive diagnostic procedures.

More than a dozen additional reported cases are currently under review by FDA.
The current labels of the two gel products instruct users to wash their hands after use, and to cover treated skin with clothing.

When product users applied gel to body parts that were not indicated in the product’s labeling, they “increased the opportunity for a child to be inadvertently exposed,” Murphy said.
The FDA recommends that children and women avoid contact with the places where men have applied these products. The agency also recommends that adults who use testosterone gels always do the following:

• Wash hands with soap and water after every application.• Wash the site where the gel was applied with soap and water before coming into skin contact with another person, especially children.

• Cover the application site with clothing when gel has dried.

• Note that the use of non-FDA-approved testosterone gels that can result the same effects should be avoided.

Health care professional and consumers are urged to contact the FDA with adverse event or product quality issues with the contact information below.

–Regular Mail: use postage-paid FDA form 3500 available at: and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
–Fax: (800) FDA-0178
–Phone: (800) FDA-1088

For more information please see:

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

Legal Disclaimer & Privacy Policy
This web site is designed for general information only. The information presented should not be construed as legal advice and does not form the basis for an attorney/client relationship.

The choice of a lawyer is an important decision and should not be based solely on advertisements.
This web site is not intended to be advertising, and Schlichter Bogard & Denton LLP does not desire to represent anyone desiring representation based upon viewing this web site in a jurisdiction where this web site fails to comply with all laws and ethical rules of that jurisdiction. Materials on this web site may only be reproduced in their entirety (without modification) for the individual reader's personal and/or educational use and must include this notice.

We will not disclose, sell, or rent any of your identifiable personal information to any third party, unless approved by you, or required by law.