Safety Alerts & Recalls

What does this mean?

Accidental exposure to Testosterone generally occurs when you do not follow instructions for appropriate medication use and then have direct contact between treated skin and another person. If you are using Testosterone, the FDA recommends the following precautions be taken to reduce the potential for secondary exposure: 1) Wash your hands with soap and warm water after every application; 2) Cover the application site with clothing once the gel has dried; 3) Wash the application site thoroughly with soap and warm water prior to any situation where skin-to-skin contact with another person is anticipated; 4) Children and women should avoid contact with testosterone application sites on the skin of men who use these products; and 5) Avoid use of any similar, but unapproved, products from the marketplace, including the Internet, that can result in the same serious adverse effects.

If you use Testosterone and have regular contact with children, please immediately contact the child's doctor or other health care provider if you notice signs of development of male secondary sexual characteristics such as inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, or aggressive behavior.

If you have any questions about how to properly use Testosterone, please follow up with your doctor, pharmacist, or other health care provider.

Boxed Warning Added to Testosterone Gel Products (Androgel, Testim)

The Food and Drug Administration (FDA) announced that it is requiring manufacturers of two prescription testosterone gel products, AndroGel 1% and Testim 1%, to include a new boxed warning. Androgel and Testim are gels applied to the skin for use in men who either no longer produce testosterone or produce it in very low amounts.

The boxed warning will provide additional information about the risk of accidental exposure of another person to testosterone through contact with a person being treated with these products, also known as secondary exposure. The boxed warning will include the steps that should be taken to reduce this risk. The FDA is also requiring manufacturers to develop a Medication Guide to be dispensed with every prescription of Testosterone.

The FDA is requiring this updated labeling after receiving reports of adverse effects in children who were accidentally exposed to testosterone gel. These reports include cases of inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior. In most cases, the signs and symptoms went away when the child no longer was exposed to the product. However, a few cases required additional medical monitoring or hospitalization.

For more information, please visit: more information here

more information here

Source: FDA
Publication Date: 2009-05-07
Last Updated: 2009-12-05

Visit the medication page for the following drugs:

Share your story Share your story! Tell us how MediGuard has helped you or someone you love. Mobile graphic Download the MediGuard Mobile App to manage your prescription and over-the-counter medications, for free. Registration Info Taking multiple medications puts you at risk for possible drug-drug interactions Registration Info Monitor the medical treatment of you and your loved ones.