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The Food and Drug Administration (FDA) announced on May 7, 2009, that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products' labels.
The agency is requiring this action after receiving reports of bad side effects in children who were exposed to testosterone by accident through contact with another person being treated with these products (secondary exposure).
FDA approved the gels for use in men who either no longer produce the male sex hormone testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. Only AndroGel 1% is approved to apply to the abdomen.
Precautions in the current labels instruct users to wash their hands after using the product and to cover the treated skin with clothing. Despite these labeled precautions, as of Dec. 1, 2008, FDA has received reports of eight cases of secondary exposure to testosterone in children ranging in age from 9 months to 5 years. FDA continues to receive and review additional reports of secondary exposure.
In most of the cases, users of these products failed to follow the instructions for appropriate use, resulting in direct contact between the treated skin and the child.
Side effects reported in children include
- inappropriate enlargement of the external sexual organs (penis or clitoris)
- premature development of pubic hair
- advanced bone age
- increased self-stimulation
- aggressive behavior
In most cases, the signs and symptoms lessened when the child was no longer exposed to the product. However, in a few cases, enlarged sexual organs did not fully return to the child's age-appropriate size and bone age remained greater than the child's chronological age.
FDA is requiring the manufacturers of these products to
- make product label changes that will provide additional information about the risk of secondary exposure and the steps that should be taken to reduce this risk
- develop a Medication Guide to be given to people each time they receive these products from a pharmacy
- carry out a plan to ensure that the benefits of these products continue to outweigh their potential risks
- Adults who use testosterone gels should wash their hands with soap and warm water each time they apply the gel.
- Adults should cover the area where they have applied the gel with clothing once the gel has dried.
- Adults should wash the area where they apply the gel thoroughly with soap and warm water prior to any situation where skin-to-skin contact with another person may occur.
- Children and women should avoid contact with areas of skin where men have applied the gel.
- Adults should note that using any similar, but unapproved, products from the marketplace—including the Internet—can result in the same serious side effects and should be avoided.
- Adults should contact their child's health care professional if they see any signs of the child's exposure to testosterone gels.
- Health care professionals and consumers may report serious side effects or product quality problems with the use of these gels to FDA's MedWatch
- Adverse Event Reporting program either online, by regular mail, fax or phone.
- Online: MedWatch Reporting
- Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: (800) FDA-0178
- Phone: (800) FDA-1088
AndroGel 1% is manufactured by Solvay Pharmaceuticals in Marietta, Ga. Testim 1% is made by Auxilium Pharmaceuticals in Malvern, Pa.
This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.
Date Posted: May 8, 2009