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WASHINGTON — A hormone patch that works to restore a woman's sex drive should not win government approval until more studies are completed to determine the drug's risks, federal health advisers recommended Thursday. Several members of the Food and Drug Administration's 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 the drug. Procter & Gamble sought to market the testosterone patch Intrinsa (search) to women who lost their libido (search) after their ovaries were removed. The company told the committee that significant safety concerns had not come up in clinical trials and that there was no reason to delay approval of the first drug for female sexual dysfunction. But the committee unanimously sided on the need for more safety data. The company said in a statement it would work closely with the agency 'to agree on a practical approach to provide additional safety data.' The FDA is not bound by the committee's recommendation, although the agency usually follows the guidance. An agency decision on Intrinsa is expected in a few weeks.
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