WASHINGTON - The hormone patch Intrinsa aims to restore women's lost libido, but some health experts are concerned that potential health risks may eclipse the benefit of marginally better sex.
A Food and Drug Administration advisory panel was considering Thursday whether the agency should approve the first drug to treat hypoactive sexual desire disorder in women who have had their ovaries removed or damaged and are receiving estrogen therapy.
Women with the disorder have a sex drive that is so diminished that they no longer fantasize about sex or crave it, causing stress and strained relationships.
Procter & Gamble is seeking FDA approval to sell the testosterone patch Intrinsa, the first such product to treat a condition that affects up to 3 million surgically menopausal American women.
Clinical trials showed that women using Intrinsa had only modest improvements to their sex lives. Women who applied the patch to their abdomen twice weekly had one more "satisfying sexual event" per four weeks, compared with a placebo.
The FDA, chastised before Congress for ignoring safety concerns with drugs, has asked its Reproductive Health Drugs advisory committee to consider whether that slim benefit offsets potential risk from long-term use of the hormone testosterone. Women using the Intrinsa testosterone patch will also take estrogen.
The Women's Health Initiative, a program established by the National Institutes of Health, found that postmenopausal women taking the hormones estrogen and progestin had higher risks of heart attack, stroke and breast cancer.
"The unexpected safety findings ... indicated that short-term or uncontrolled studies may not provide adequate estimates of the risks of hormonal therapy," the FDA told its advisory panel.
Mary Johnson, a Procter & Gamble spokeswoman, said, "Those questions were not unexpected and they will be addressed during the presentation."
Procter & Gamble's safety testing of the drug included 419 women who used Intrinsa for up to one year. A three-year safety study will include 321 women.
In addition, the company plans a post-marketing study to track women taking Intrinsa for five years to determine rates of heart disease and breast cancer.
Critics were lobbying federal advisers to delay action or deny approval.
