FEMALE VIAGRA APPROVED BY FDA ADVISORY PANEL

[HairOfTheDog]

A drug to treat low female sexual desire should be approved with strict measures in place to ensure patients are fully aware of its risks, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday.

The FDA, which has twice rejected the drug, Flibanserin, is not obliged to follow the advice of its advisory panels but typically does so.

The drug works differently from Viagra, which is used to treat erectile dysfunction and has been available since 1998. Flibanserin works on the brain while Viagra affects blood flow to the genitals.

Flibanserin was originally developed as an antidepressant by Boehringer Ingelheim, which sold the drug to Sprout following a negative advisory panel meeting in 2010.

The benefits of the drug are marginal, panelists said, but meaningful for some patients. Serious side effects include the risk of fainting at unpredictable times, accidental injury and low blood pressure.

The panel's recommendation follows months of lobbying by the drug's developer, privately held Sprout Pharmaceuticals, aided by a number of women's advocacy groups which accused the FDA of gender bias, a charge the agency rejects.

Potential risk management measures suggested by the panel included requiring physicians to be certified before being allowed to prescribe the drug and requiring pharmacies to confirm the physician's certification, establishment of a patient registry, additional safety studies after the drug is on the market, and a warning against the use of alcohol when taking the drug.

Dozens of women spoke to the panel about the distress caused by their low sexual desire and urged the FDA to approve the drug, whose proposed trade name is Addyi.

Others characterized Sprout's lobbying campaign as an attempt to bully the FDA into approving a drug with modest benefits and real safety concerns. Some panelists said they were concerned that patients could faint while behind the wheel of car or in other circumstances that could lead to serious injury or death.

Full story: http://www.cnbc.com/id/102735987
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I guess if some women (and probably even more men) want women to have access to this pill, it should be made available.

But, if ever I reach a point where my sex drive is very low, I wouldn't take a daily brain-altering pill to try and boost it. I don't take any pills though, never have.

Is this a good thing or simply the latest chapter in the highly-profitable "just take a pill, honey" files?