Marlen Garcia: 'Female Viagra' not only drug with side effects

SHARE Marlen Garcia: 'Female Viagra' not only drug with side effects
FLIBANSERIN_999x749.jpg

A tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company’s Raleigh, N.C., headquarters. Government health experts on June 4, 2015 backed the approval of the experimental drug intended to boost the female sex drive, but stress that it should carry safety restrictions to manage side effects including fatigue, low blood pressure and fainting.

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Would you take a drug that could cause side effects such as headaches, nausea, blurred vision, back pain, dizziness or a rash if it improved your sex life?

Millions of men do. It’s called Viagra.

They take that or similar drugs so they can have sex, despite warnings of potentially more serious but rare side effects that include sudden vision or hearing loss.

OPINION

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Last week an expert health panel for the Food and Drug Administration voted in favor of allowing the sale of the drug flibanserin to improve low or no libido in premenopausal women. It, too, could cause side effects that range from dizziness and nausea to the more rare: low blood pressure and fainting.

Dubbed female Viagra, it isn’t all that similar to it. Drugs that treat erectile dysfunction are taken as needed. Flibanserin, which must be taken daily, improves sexual desire over time by increasing dopamine and noradrenalin and decreasing serotonin in the brain.

The FDA will decide whether to approve the drug by Aug. 18, and the media blitz between those arguing for and against the drug will continue until then.

Those who are against the drug point to “modest” benefits to conclude it isn’t good enough. Some, including Adriane Fugh-Berman, a doctor and professor at Georgetown University and director of a medical watchdog group for pharmaceutical marketing, were a bit more extreme. She called it “a mediocre aphrodisiac with scary side effects.”

But its side effects aren’t nearly as scary as sleeping pills.

Many drugs come with potentially serious side effects and more common ones that usually diminish over time. If they become intolerable, you stop taking the drug. Alcohol should be avoided with many drugs, this one included. If approved, it would come with appropriate warning labels.

As for “modest” benefits, most women who struggle with hypoactive sexual desire disorder want exactly that, according to two doctors I interviewed, one who is associated with the company that makes flibanserin, Sprout Pharmaceuticals, and another who isn’t.

“Clearly there will be responders who run the gamut,” said Lauren Streicher, a doctor with Gynecologic Specialists of Northwestern University who wrote candidly of sexual issues for women in “Sex Rx: Hormones, Health and Your Best Sex Ever.” She is not associated with Sprout.

“There are women who will say, ‘I felt 20 again with great libido,’ ” Streicher said. “There are women who will say, ‘I felt a little better’ from not [wanting sex] at all.”

Said Sheryl Kingsberg, a clinical psychologist in obstetrics and gynecology at University Hospital Case Medical Center in Cleveland who worked as a clinical investigator for Sprout: “Success is not taking someone with no desire to having desire all the time. They want to restore desire to sometimes. That’s modest.”

The doctors said drug companies are working to develop medications that can be dosed like the “taken-as-needed” model for men. But research for women’s drugs will end if the FDA does not approve flibanserin, backers say.

“If it does not get approved … no drug will get approved,” Kingsberg said. “Companies researching sexual dysfunction will dry up.”

I agree with Streicher, who said, “Just because you don’t have something better, it doesn’t mean you don’t approve” this one.

This drug should be the industry’s starting point.

Follow Marlen Garcia on Twitter: @MarlenGarcia777

Email: MarlenGarcia777@yahoo.com

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