Remember ‘the female Viagra’ and the great clamour over US Food and Drug Administration’s approval of the ‘little pink pill’ last year?
Well, the drug to treat waning sex drive in women hit American markets 4 months ago, but it is linked only to a ‘marginal’ increase in sexual arousal and satisfaction, according to a new study published in medical journal JAMA.
Let me recap it for you: The drug -Flibanserin (fluh-BAN-ser-in- generic name), or Addyi, the brand name created a lot of buzz last year. It was hyped as the drug that will soar libido, self-esteem and improve relationships. Sounded like the perfect miracle pill.
We told you back in August 2015 that women should not be celebrating just yet because in clinical trials, the pill was only a little more effective than placebo and that has been proved now.
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Precisely why twice in the past, 2010 and 2013, the US FDA declined to approve it, citing potential risks and marginal benefits. But then, the pharma giants played on the lines of women empowerment, gender bias. The debate on the safety and efficacy of the drug turned into whether the FDA was being sexist in not approving a drug for female desire.
Basically pharmaceutical giants gamed the system and the US FDA folded. Don’t get me wrong, I am all for women getting their groove back but making them into dizzy and nauseous guinea pigs is plain brutal.
The Problems With Flibanserin or Addyi
Half or one satisfying sexual encounter a month. That is the average benefit a woman gets when she takes Addyi, according to a research published in medical journal JAMA.
Scientists analyzed eight studies of about 5,900 women and concluded that treatment with flibanserin, now marketed as Addyi, resulted in “one-half of an additional sexually satisfying encounter per month, which is marginal.” The study did not define what “one-half” of a sexually satisfying encounter was.
The biggest concern is the side-effects which occurred in 1out of 3 women - low blood pressure, fainting spells, even unconsciousness if the pill was mixed with alcohol.
The drug is not selling well either. Till the end of last month, it was generating an average of only 250 prescriptions a week in the whole of US.
Addyi and Viagra Are Vaguely Related
Viagra for men and Addyi for women - they both fall under the same umbrella topic of “sex” drugs, but that’s about it.
Viagra treats sexual dysfunction in men by relaxing the blood vessels in the penis so that an erection can occur. It’s that easy to treat sexual disorders in men and that’s why there are 26 FDA approved drugs for the same in the market.
But male and female sex problems have nothing in common.
Very rarely is low libido in women a physical issue. It is mostly mental and emotional factors that lead to disinterest in sex. Flibanserin, on the other hand works by normalising dopamine, serotonin and noradrenaline levels in the female brain.
But there are other factors on which women’s sex drive is dependent, like low self-esteem or a mundane relationship and these aren’t things which can be dealt with medically. And sex drive weans with age too.
The big question then, while the women in the trial reported ONE extra episode of sexual satisfaction than those on placebo, was the positive trend enough for the FDA to outweigh its risks? And is one extra sexual event even meaningful? I think women have already answered that question with their lack of enthusiasm in getting prescriptions.
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