Herbal Spotlight
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 testosterone gel |
| Androgel, Testim |
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Pharmaceutical
company:
Various manufacturers
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NEW WARNING
The Food and Drug Administration (FDA) is requiring
Solvay Pharmaceuticals and Auxilium Pharmaceuticals, manufacturers of the testosterone gel products AndroGel 1% and Testim 1%, to include a boxed warning in the prescribing information. The boxed warning is in response to reports of children suffering secondary exposure to testosterone after having contact with patients being treated with these products.
Testosterone gel products are indicated for use in men who no longer produce testosterone or produce it in reduced amounts. These precautions should be taken to reduce the risk of secondary exposure:
- Patients should wash their hands with soap and water after each application.
- Patients should cover the application site with clothing after the gel dries.
- Patients should wash the application site with warm water and soap before any situation in which skin-to-skin contact is likely.
- Women and children should avoid contact with application sites on the skin of men who are using these products.
- Similar unapproved products should be avoided because they can cause similar adverse reactions.
Report adverse reactions to the FDA's MedWatch Adverse Event Reporting Program at 1-800-FDA-1088.
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