Accidental testosterone exposure in women and children

 

Testosterone is a hormone in the body that is primarily responsible for the normal growth and development of male sexual and reproductive organs. It is important in maintaining bone health, energy levels, mood, and sexual desire.

If men have low testosterone levels, doctors may prescribe testosterone gel products such as AndroGel 1% and Testim 1% to restore normal levels of testosterone. The gel is easy to use. It is applied once daily to the shoulders or upper arms. AndroGel can also be applied to the abdomen. The area should be covered to avoid skin contact with other people. Also, consumers who use these products need to wash their hands after applying the medicine.

Adverse effects can occur in children and women who are accidentally exposed to the drug. The drug can cause harm to a pregnant woman's developing fetus and can cause the development of masculine characteristics in children and women. Unfortunately, the Food and Drug Administration (FDA) recently announced eight cases of adverse effects in children. These occurred because of skin-to-skin contact with a person using the drug. The children ranged in age from 9 months to 5 years. They had signs of enlarged reproductive organs, increased sexual feelings, growth of pubic hair, advanced bone age, and aggressive behavior. In most cases, the adverse effects went away when the child was no longer exposed to the drug.

FDA is requiring stronger warnings on the product labels about the risk of accidental exposure. They developed a list of things to do to help avoid accidental exposures. To view FDA's press release, go to: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149580.htm.

Here's what you can do: Talk with your doctor, nurse, or pharmacist about the proper use of this medicine. Also, follow these steps when you use testosterone gel products.

  • Wash your hands with soap and water after every use.
  • Cover the area with clothing once the gel has dried.
  • Wash the area thoroughly with soap and water if there will be skin-to-skin contact with another person.
  • Consider asking your doctor if you can use the patch form of the drug.

Advice from FDA is a feature brought to you by the US Food and Drug Administration (FDA). You can find this article and more on FDA's Consumer Health Information website at: www.fda.gov/ForConsumers/default.htm. This website features the latest updates on medicines and products regulated by the FDA. To receive this information, sign up for a free email subscription at: https://service.govdelivery.com/service/subscribe.html?code=USFDA_9

Created on March 7, 2012