Daily Management Review

The US Lifted the Ban from 'Viagra for Women'


06/05/2015


After two taboos and the following strong lobbying campaign, the US officially approved flibanserin - the world's first drug for restoring sexual desire in women. It is reported by The New York Times.



ABC News
ABC News
The advisory panel of the Food and Drug Administration (FDA) approved the drug for women with 16 votes to eight, the weakening of the libido of which is not related to disease and disorder in the relationship. However, the doctors are obliged to inform patients about the side effects of medication (low-pressure, fainting, nausea, and dizziness).

Flibanserin was created as an antidepressant by the German firm Boehringer Ingelheim, but after the failure of FDA in 2010, the Germans had sold him to a small US company Sprout. In 2013, the FDA rejected the "Viagra for women" again.

After that, women's organizations (using Sprout) launched a powerful campaign. The activists accused the FDA of gender discrimination: the organization allegedly approved Viagra and other drugs to improve the sex life of men, but had done nothing for women.

However, other non-governmental organizations have criticized the campaign believing that is just an ugly attempt to take advantage of women's rights to promote the controversial drug. "The approval of flibanserin create the worst possible precedent - companies, ready to spend a lot of money on publicity, FDA may impose useless or even dangerous means," - said the head of the project to combat the dominance of PharmedOut pharmaceutical firms.

Flibanserin must be taken once a day at bedtime. The drug is designed for premenopausal women, as it acts on serotonin and dopamine in the brain. Results from clinical trials indicated a slight increase of libido. Taking the medication, the patients reported one additional case of sexual satisfaction in a month (2-3 times before). The patients have estimated the increase of sexual desire at 0.3 points on a six-point scale.

The severe side effects, even though not all the women have experienced them, caused che concern of doctors. There are the pressure drops and fainting carrying the risk of serious injury. Moreover, the chance of side effects increases with the use of alcohol and many popular drugs.

The FDA must take the final decision on August 18. Normally, the management obey its committees’ decisions, but in this case, too many voters expressed their concerns (due to low efficiency and serious side effects of the drug). However, most of the experts approved the ‘Viagra for women’.
- The population in is a huge unmet need for such a medicine, even though it’s mild. I think that now, the most appropriate step would be to approve flibanserin and severely restrict the prescribing criteria, - said a committee member, an expert on drug safety Tobias Gerhard.

 






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