Are there health concerns over ‘Female Viagra’ even after FDA’s approval?

meet addyiAddyi, commonly known as ‘female Viagra’, is a drug made for women to increase their libido. It has passed the test and won the approval of the FDA last weekend. Feminists have finally gained a victory in their struggle, which has been continuing for many years. The various reports and questions by opposing scientists regarding its efficiency had forced the FDA to reject this drug in 2010 as well as in 2013, but recently approved the controversial drug.

The basic question here is: Why can’t women have a drug similar to male Viagra to fulfill their sexual needs?

The Third Trial

Addyi drug was the first step towards freeing women from the ‘old-school stereotypes’ and letting them take control of their own sexuality by increasing their urges, so that they can be involved in more regular sexual activity. However, the critics have stated that it might be a health risk to use the drug without further testing on women. Moreover, they said that it can also be dangerous if taken with alcohol and could have adverse side-effects.

Although the testing of the drug did take place on 25 patients, out of which only 2 were women, the results cannot be generalized as the sample size was really small. Furthermore, out of these 25 patients, 6 had suffered serious harmful reactions which include; lowering of blood pressure, lightheadedness, and losing consciousness when they had taken it with alcohol.

Sprout finally took it upon himself to get the approval in the third trial and started a persistent, forceful and emotional campaign this time, which includes women and feminists who supported the Addyi drug. A number of people criticized the fact that the clinical reports were softening the negative aspects of the drug and that the clinical trial results were being distorted. However, in the midst of all this, Addyi made it through; with the help of its supporters and people who believed in it.

Initial Goal of the Drug

The drug was initially tested on clinically depressed men and women in 1999, by Boehringer Ingelheim, a German drug giant. Although the drug didn’t turn out to be an antidepressant, it was discovered that the intake of the drug heightened sexual urges among women after daily usage. This pill, flibanserin or Addyi, was an innovative discovery as it was a solution for the treatment of Hypoactive Sexual Desire Disorder. It was similar to Viagra, released by Pfizer, which was the drug used for curing male impotency.

Nevertheless, flibanserin still had a long way to go with outstanding issues with ownership and health risks; the debate is still ongoing even after FDA has finally made it available.

addyiRestoring the Pill

One of the sexual researchers, Irwin Goldstein, who also played a major role in the clinical trials of Viagra, did the same for Addyi. Although he was blamed for supporting pharmaceutical companies because of his good relations with them, when he was asked about it, he discarded these propositions.

“My time is valuable,” Goldstein tells Mashable. “I take good care of my patients and as a result of that some of my time should be spent helping drug companies develop products for my patients…My intentions are to help people have choices—that’s the way I work.”

The Last Push

Even after being turned down in 2013, Sprout didn’t give up on the struggle and started additional campaigns focusing on the need for additional drugs for the treatment of sexual dysfunction among females. Judy Norsigian stated that loss of urges is an actual medical condition which should not be taken lightly.

When it was added that men had 26 drugs; whereas women have none to treat sexual dysfunction, the critics retorted that all of these medications are not for low libido treatment of men and only 8 of them are approved by the FDA.

In the end, the FDA finally approved the drug which shocked a lot of its critics. However, the approval was given on the basis of meeting some strict conditions.

Calling flibanserin the ‘female Viagra’ would be using incorrect medical terminology, because Viagra has physiological impacts, whereas flibanserin has a greater effect on the chemicals in the brain which enhances the libido of women. Although the pill, like most medicines, could have additional side-effects, it is the first step towards allowing women to own their sexuality!

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