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FDA approval of female libido pill could cause women to suffer "epidemic of adverse effects"


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(NaturalNews) On August 18, the FDA approved a drug for the controversial condition of female hypoactive sexual desire disorder. The drug, flibanserin (to be marketed as Addyi), had previously been rejected twice by the agency due to low effectiveness combined with a high risk of serious side effects.

The agency's turnaround was not based on the emergence of any new evidence to exonerate the drug. Instead, it was the result of a heavy lobbying campaign by drug maker Sprout Pharmaceuticals. By caving to lobbying pressure, experts have warned, the FDA has set a dangerous precedent.

More immediately, the approval of a drug being marketed as a "female Viagra" is likely to produce an "epidemic" of serious side effects in women who falsely believe the drug maker's hype.

"Mediocre aphrodisiac with scary side effects"

Unlike Viagra, which is meant to be taken before intercourse in order to increase blood flow to the penis, Addyi is a drug that alters brain chemistry and is meant to be taken daily. Studies have shown that about one in five women who take the drug will suffer a serious side effect.

By FDA order, the drug's label will carry a bold warning that combining the drug with alcohol or certain drugs can cause dangerously low blood pressure and a loss of consciousness. The drugs that can cause these side effects include hormonal birth control pills and drugs used to treat yeast infections. For this reason, the FDA advises that women taking Addyi completely abstain from using alcohol or hormonal birth control.

According to the FDA's analysis of drug trials, only 8 to 13 percent of women who take the drug will experience a greater-than-placebo improvement in their sex life. The average benefit among women who take Addyi is 0.5 more "sexually satisfying events" per month. This unremarkable performance has led Dr. Adriane Fugh-Berman of Georgetown University, who has studied the drug's marketing campaign, to call Addyi "a mediocre aphrodisiac with scary side effects."

For this reason, analysts are predicting that the drug will never achieve the financial success of Viagra.

"A lot of prescriptions will be written and filled," said psychiatrist Leonore Tiefer of New York University. "The minuscule benefits and the very grave landscape of side effects will take their toll. I don't think the prescriptions will be renewed."

Masking real problems

Back during Sprout's intensive lobbying campaign -- in which the company publicly accused the FDA of sexism for failing to approve the drug -- Fugh-Berman warned that the consequences of approving the drug would be far-reaching.

"This may set a precedent of risky drugs being approved based on public relations campaigns rather than science," she said.

"This company already has a history of unethical marketing If approved, I think this drug will be widely prescribed, and we would see an epidemic of adverse effects."

In addition to concerns about the safety of the drug and the way its approval was secured, many experts have also raised concerns regarding the very premise the drug is founded on.

The condition of female hypoactive sexual desire disorder is controversial, and many experts have accused drug companies of inventing it to give themselves an excuse to market a drug to "cure" it. That's because sexual desire, and particularly female sexual desire, is very complicated.

"Sex is a very, very complex thing and it's very psychological in nature," said counselor and sex therapist Alyssa Siegel of Portland, Oregon.

Siegel warned that even if it works, the pill might just hide the true source of a woman's lack of sexual desire.

"While a pill can absolutely shift us internally, it's really important that external circumstances, in terms of relationship dynamics, are being addressed as well, she said.

Sources for this article include:
TheGuardian.com
USNews.com
USNews.com
CBSNews.com
KATU.com
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