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Following reports of serious problems involving children who came in contact with the prescription testosterone gel products AndroGel or Testim, the FDA is requiring that the manufacturers add a “black box” warning highlighting the risk of secondary exposure.
AndroGel and Testim are approved by the FDA for use by men with very low testosterone levels or who have stopped producing the hormone altogether. Both topical gels are approved for daily use on the upper arms or shoulders, and AndroGel is also approved for use on the abdomen.
According to the FDA, 1.4 million prescriptions were filled for AndroGel in 2007, and 370,000 prescriptions filled for Testim the same year.
Although the testosterone gels are not approved for use among females, approximately 25,000 of the prescriptions were off-label for women with diminished sex drive to increase their libido.
The potential for Testim and AndroGel side effects caused by secondary exposure are known risks associated with the medications, and the labels previously contained instructions that users should wash their hands after applying the testosterone gel and cover any treated area of skin with clothing.
The FDA has continued to receive reports of Testim and AndroGel causing problems for children who came into secondary contact with the testosterone gel. The adverse effects could cause abnormal genital growth, premature growth of pubic hair, accelerated bone development, increased libido and violent behavior.
Although the side effects often regress after exposure ceases, the FDA noted that in a few cases genital size did not return to normal and bone aging remained.
As of December 1, 2008, the FDA has received at least 8 reports of testosterone gel side effects among children between nine months and five years old, and additional reports since then are still under review.
“These drugs are approved for an important medical need, but can have serious, unintended side effects if not used properly,” said the FDA’s Janet Woodcock, M.D. “We must ensure that the adults using them are well-informed about the precautions needed to protect children from secondary exposure.”
The FDA is requiring that a prominently displayed “black box” warning be placed on the labels for both testosterone gels, and a Medication Guide is being developed to provide patients with risk information and instructions about the steps that should be taken to avoid unintended exposure side effects of AndroGel and Testim.
Users are urged to wash their hands with soap and water after every application, cover the application site with clothing until after the gel has dried and wash the application site thoroughly with soap and water before any skin-to-skin contact with other people.
The FDA also indicated that similar unapproved products that may be sold over-the-counter or on the internet, can result in the same side effects and should be avoided.