Testosterone gels used by men to boost their sexual drive can be injurious to children if they are exposed to it, warns the US FDA.
Exposure to testosterone gels can cause some very harmful effects including enlarged genitalia in kids, warned the US FDA directing the popular testosterone makers Solvay SA (AndroGel) and and Auxilium Pharmaceuticals Inc (Testim) to carry boxed warnings to their prescribing information along with their products. The US FDA also asked Solvay SA and Auxilium to develop programmes to minimize the risks. Related story: LibiGel, Flibanserin female sexual dysfunction gels
Besides the more harmful effects like enlarged genitalia, even second-hand exposure to testosterone gels may also cause some highly unpleasant consequences like increased sex drive and premature development of pubic hair in children, the US Food and Drug Administration said in a statement.
The testosterone gels Androgel and Testim are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Related story: Testosterone contraceptive injection for men
AndroGel and Testim gels are applied once daily, to the shoulders or upper arms. However, AndroGel is approved for application to the abdomen, as well.
Dangers of exposure to testosterone gels
- Premature enlargement of genitalia in male and female children
- Premature development f pubic hair
- Increased sex drive in children
“These drugs are approved for an important medical need, but can have serious, unintended side effects if not used properly,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “We must ensure that the adults using them are well-informed about the precautions needed to protect children from secondary exposure.”
Precautions in the current labels instruct users to wash their hands after using the product and to cover the treated skin with clothing.
According to FDA, nearly 1.77 million prescriptions for testosterone gels were filled in 2007. AndroGel, the most commonly dispensed gel form of testosterone, filled 1.4 million prescriptions dispensed by US retail pharmacies. Approximately 25,000 of those were dispensed for off-label use in women.
Nearly, 370,000 prescriptions were dispensed for Testim during the same period.
FDA received more than 20 reports of side effects in young children since 2000, mostly following direct contact with treated skin.
Besides, till Dec. 1, 2008, the FDA has received reports of eight cases of secondary exposure to testosterone in children ranging in age from nine months to five years.
FDA reviews showed that adverse events due to testosterone exposure reported in these children included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior.
The signs and symptoms returned to normal when the child no longer was exposed to the product, in most cases. However, in a few cases, enlarged genitalia did not fully return to the size suitable to their age and bone age remained modestly greater than the child’s chronological age.
Some of the children had to undergo surgical diagnostic procedures or hospitalization and undergoing surgery due to a delay in recognizing the underlying cause of the signs and symptoms.
The FDA review found that, in most of the cases, users of these products failed to follow appropriate use instructions, resulting in direct contact between treated skin and the child.
The required label changes will provide additional information about the risk of secondary exposure and the steps that should be taken to reduce this risk.
The FDA also is requiring that the manufacturers of these products develop a Medication Guide as part of a Risk Evaluation and Mitigation Strategy to ensure that the benefits of these products continue to outweigh their potential risks.
The US National Institutes of Health estimates that about 5 million American men have low testosterone, while some studies suggest the number may be as high as 13 million. The condition can be caused by aging, testicular cancer or use of medicines including morphine or steroids.