New drug restores women’s lost libido, raises safety concerns
Dec. 02, 2004
Provided by: Canadian Press WASHINGTON (AP) – The manufacturer of a hormone patch aimed at restoring women’s lost libido told U.S. federal health advisers Thursday that the therapy has not been linked to any serious safety problems and urged that approval not be delayed because of an unknown risk.
“It is not uncommon to have unanswered safety questions at approval,” said Joan Meyer, senior director of new drug development for Proctor & Gamble. If it wins Food and Drug Administration approval, Intrinsa would be 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. The condition affects up to three million surgically menopausal American women.
Clinical trials showed that women using Intrinsa had 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 panel was hearing later Thursday from health experts urging that approval of the drug be delayed until more long-term safety data is available.
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 post-menopausal 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,” FDA staff told its advisory panel.
Meyer told the panel Thursday that the company will soon have more safety data adding information for nearly 200 women who’ve used the patch for one year. The company will also provide safety data on 100 more women who have used the patch for 18 months. Eighty women have been using the product for three years.
Another company official, Michael Steinbuch, argued against using a randomized clinical trial after the drug is approved. The company instead wants to observe what happens with women who are taking the drug and compare their heart disease and cancer rates with a database containing the records of 10 million patients.
“We believe this is the best study design for detecting possible safety signals quickly ,” said Steinbuch, Procter and Gamble’s director of the group that designs studies looking for drug safety problems.
He said it would take several years to set up a randomized control trial. But the trial the company proposes would be able to detect any problems within two years of the drug being released.
Documents provided to the committee Thursday said 494 surgically menopausal women were treated with the patch in combination with estrogen for one year. Of those, 127 were treated for 18 months. The placebo controlled safety data that they will review only covers six months.
Dr. Leonore Tiefer, a sexuality expert at New York University’s School of Medicine, was asking the committee to postpone a ruling until researchers get additional safety data.
“We’re talking about a long-term hormonal treatment here,” Tiefer said. “In order to demonstrate the safety of it, we need to study it for a couple of years – not 12 and 24 weeks.”
Consumer advocate Dr. Sidney Wolfe also expressed concern about testosterone’s known risks. “This is a dangerous substance and there has not been anywhere near enough adequate information on the risks” said Wolfe, director of Public Citizen’s Health Research Group.
The advocacy group Breast Cancer Action raised questions about possible use of the patch by women whose sex drives were diminished due to other reasons, such as chemotherapy.