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FDA getting cold feet on "female libido" patch

Well at least the Vioxx mess is now making them at least take a look at the sh*t they are trying to foist on the public. New Female Sex Drug Raises Safety Concerns. Just the fact that the benefits are marginal and they don’t know the long term risks of use, suggests, yet again, the FDA is asleep at the wheel and your health is on the line. By the way, it’s Proctor & Gamble trying to get this onto market.

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.

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.

Oh, and if you want to see P&G;’s version of the efficacy of this patch (and you know it’s glowing research), check out their press release.

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Pam Spaulding

Pam Spaulding