Thursday, December 02, 2004

More testing needed for Procter & Gamble's Intrinsa

Possibly in reaction to the issues with VIOXX, members of the Food and Drug Administration advisory committee said they were not satisfied with the number of women studied so far, the length of the studies and the modest benefits of Procter & Gamble's testosterone patch Intrinsa.

Procter & Gamble sought to market Intrinsa to women who lost their libido after their ovaries were removed. P&G said that the panel had not raised significant safety concerns in clinical trials, and P&G advocated that the panel not to delay approval of the first drug for female sexual dysfunction.

Dr. Charles Lockwood said: "So, I think if there is one single element of safety that deserves the most scrutiny, it is the potential role of this patch in promoting thromboembolic disease."


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