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This is an archive article published on December 4, 2004

Female Viagra fails to get the nod from US regulators

A US federal advisory panel voted unanimously on Thursday that the first drug to enhance the sex drive of women should not be approved, beca...

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A US federal advisory panel voted unanimously on Thursday that the first drug to enhance the sex drive of women should not be approved, because there is not enough information about its long-term safety.

Members of the committee said that the possible risks of the drug — a patch containing the hormone testosterone developed by Procter & Gamble — outweighed what some saw as only a modest benefit in increasing desire and the frequency of sex.

‘‘I am not devaluing the importance of this symptom and its treatment,’’ said Dr Steven Nissen, a cardiologist at Cleveland Clinic and a panel member. ‘‘But I also don’t want to expose several million American women to the risk of heart attack and stroke, with their devastating consequences, in order to have one more sexual experience per month.’’

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The Food and Drug Administration, which convened the meeting, will have the final say on the hormone patch, which is called Intrinsa.

Intrinsa appears to have been rebuffed not for any known safety problems — but rather because its backers have been unable to rule out possible long-term effects, like possibly contributing to breast cancer and heart problems.

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