Testosterone Gels May Rub Off on Kids During Cuddling (Update3)
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By Catherine Larkin
May 7 (Bloomberg) -- Popular testosterone gels made by Solvay SA and Auxilium Pharmaceuticals Inc. may inadvertently rub off on children with harmful effects, including enlarged genitalia, U.S. regulators said.
Secondhand exposure to the products, used to boost sex drive in aging men, may also cause children to have increased libido and premature development of pubic hair, the Food and Drug Administration said today in a statement. The FDA ordered manufacturers to add boxed warnings to their prescribing information and to develop programs to minimize the risks.
About 1.77 million prescriptions for testosterone gels were filled in 2007, according to the FDA. While patients have been advised to wash their hands after use, more than 20 reports of side effects in young children were reported to the agency since 2000, mostly following direct contact with treated skin.
“These drugs are approved for an important medical need, but can have serious, unintended side effects if not used properly,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the statement. “We must ensure that the adults using them are well-informed about the precautions needed to protect children from secondary exposure.”
The U.S. 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. Gels, along with injections, patches and gum tablets, treat symptoms that include decreased sex drive, irritability or a loss of muscle mass.
FDA Review
Most of the reports of secondhand exposure reviewed by the FDA involved adults cuddling or holding boys and girls after applying the gels. One case may have stemmed from children touching clothing, the agency said. Gels are intended to be applied once daily to shoulders or upper arms and then covered. AndroGel also is approved for use on the abdomen.
While side effects usually go away after children are no longer exposed to the gels, the FDA said at least one child was hospitalized and underwent surgery because of a delay in recognizing signs of testosterone exposure. In other cases, symptoms of larger-than-normal genitalia or advanced bone age continued through childhood, the agency said.
AndroGel, made by Brussels-based Solvay, was the first testosterone gel approved by the FDA, in 2000. The drug brought in 337 million euros ($496 million) for Solvay last year, second to the cholesterol medicine fenofibrate.
Expanded Use
Solvay applied in 2007 to sell AndroGel to treat low testosterone levels and delayed puberty in boys ages 13 to 17. FDA reviewers recommended rejecting the application over questions about dosing and safety, according to documents posted on the agency’s Web site.
“Safety has always been and remains a priority for Solvay Pharmaceuticals,” Neil Hirsch, a spokesman for the company, said today in an e-mailed statement. Solvay “will work collaboratively with the FDA regarding this recent request,” he said.
Generic drug companies Watson Pharmaceuticals Inc., of Corona, California, and Par Pharmaceutical Cos., of Woodcliff Lake, New Jersey, agreed in 2006 to help co-promote AndroGel in the U.S. as part of a settlement. The Federal Trade Commission sued the three companies this year, saying they colluded to delay lower-cost copies of the medicine.
Auxilium won U.S. approval for its testosterone gel, Testim, in October 2002. The drug had sales of $125.2 million last year and is Auxilium’s only marketed product. The Malvern, Pennsylvania-based company didn’t immediately return voice-mail messages seeking comment.
Auxilium rose $1.21, or 5.3 percent, to $23.85 at 4 p.m. New York time in Nasdaq Stock Market composite trading. Watson gained 4 cents to $29.74 in New York Stock Exchange composite trading. Par increased 2 cents to $11.72. Solvay fell 28 euro cents to 66.15 euros in Brussels before the FDA announcement.
To contact the reporter on this story: Catherine Larkin in Washington at [email protected].
Last Updated: May 7, 2009 16:14 EDT
Share | Email | Print | A A A
By Catherine Larkin
May 7 (Bloomberg) -- Popular testosterone gels made by Solvay SA and Auxilium Pharmaceuticals Inc. may inadvertently rub off on children with harmful effects, including enlarged genitalia, U.S. regulators said.
Secondhand exposure to the products, used to boost sex drive in aging men, may also cause children to have increased libido and premature development of pubic hair, the Food and Drug Administration said today in a statement. The FDA ordered manufacturers to add boxed warnings to their prescribing information and to develop programs to minimize the risks.
About 1.77 million prescriptions for testosterone gels were filled in 2007, according to the FDA. While patients have been advised to wash their hands after use, more than 20 reports of side effects in young children were reported to the agency since 2000, mostly following direct contact with treated skin.
“These drugs are approved for an important medical need, but can have serious, unintended side effects if not used properly,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the statement. “We must ensure that the adults using them are well-informed about the precautions needed to protect children from secondary exposure.”
The U.S. 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. Gels, along with injections, patches and gum tablets, treat symptoms that include decreased sex drive, irritability or a loss of muscle mass.
FDA Review
Most of the reports of secondhand exposure reviewed by the FDA involved adults cuddling or holding boys and girls after applying the gels. One case may have stemmed from children touching clothing, the agency said. Gels are intended to be applied once daily to shoulders or upper arms and then covered. AndroGel also is approved for use on the abdomen.
While side effects usually go away after children are no longer exposed to the gels, the FDA said at least one child was hospitalized and underwent surgery because of a delay in recognizing signs of testosterone exposure. In other cases, symptoms of larger-than-normal genitalia or advanced bone age continued through childhood, the agency said.
AndroGel, made by Brussels-based Solvay, was the first testosterone gel approved by the FDA, in 2000. The drug brought in 337 million euros ($496 million) for Solvay last year, second to the cholesterol medicine fenofibrate.
Expanded Use
Solvay applied in 2007 to sell AndroGel to treat low testosterone levels and delayed puberty in boys ages 13 to 17. FDA reviewers recommended rejecting the application over questions about dosing and safety, according to documents posted on the agency’s Web site.
“Safety has always been and remains a priority for Solvay Pharmaceuticals,” Neil Hirsch, a spokesman for the company, said today in an e-mailed statement. Solvay “will work collaboratively with the FDA regarding this recent request,” he said.
Generic drug companies Watson Pharmaceuticals Inc., of Corona, California, and Par Pharmaceutical Cos., of Woodcliff Lake, New Jersey, agreed in 2006 to help co-promote AndroGel in the U.S. as part of a settlement. The Federal Trade Commission sued the three companies this year, saying they colluded to delay lower-cost copies of the medicine.
Auxilium won U.S. approval for its testosterone gel, Testim, in October 2002. The drug had sales of $125.2 million last year and is Auxilium’s only marketed product. The Malvern, Pennsylvania-based company didn’t immediately return voice-mail messages seeking comment.
Auxilium rose $1.21, or 5.3 percent, to $23.85 at 4 p.m. New York time in Nasdaq Stock Market composite trading. Watson gained 4 cents to $29.74 in New York Stock Exchange composite trading. Par increased 2 cents to $11.72. Solvay fell 28 euro cents to 66.15 euros in Brussels before the FDA announcement.
To contact the reporter on this story: Catherine Larkin in Washington at [email protected].
Last Updated: May 7, 2009 16:14 EDT
