Digital Journal reported on August 18, 2015, that Addyi, a drug that works on the brain to boost younger women’s libido if they have lost interest in sex, was given approval by the Food and Drug Administration.
Addyi, also known as flibanserin, is manufactured by North Carolina-based Sprout Pharmaceuticals. It is a daily medication that cannot be taken with alcohol and certain drugs. One serious side-effect that women do need to be aware of is the potential for fainting. The other side-effect is the very dangerous effects that will occur when the medication is combined with alcohol.
The FDA approved Addyi specifically for a condition known as “acquired, generalized hypoactive sexual desire disorder (HSDD),” or sudden and severe loss of libido. Be warned, though, only certified pharmacies will be allowed to dispense Addyi, and only trained doctors may prescribe the medication.
Addyi had a tough time meeting FDA requirements
Mashable cites the two previous failures to bring the drug to market, one in 2010, and the other in 2013 because of inconclusive evidence that the drug was any better than a placebo. And that evidence is still a major bone of contention with critics.
It was only after Sprout used a more aggressive campaign, signing up women’s groups to back their claims — that Addyi was a feminist-approved way to a healthy sex life — that the FDA finally caved. But still, the critics claimed that the lack of real data and misrepresented clinical trials influenced FDA approval.
“They really struggled with this, even agonized over the decision,” said CBS News chief medical correspondent Dr. Jon LaPook. “Because they said the benefits were kind of modest and there were some significant side effects they were worried about: dizziness, sleepiness, and when used with alcohol, fainting.”
According to the FDA, four clinical trials were undertaken, involving 1,543 premenopausal women with HSDD. The list of adverse effects is long and worth reading, including the studies on pregnant women. The FDA says, ” Animal studies cannot rule out the potential for fetal harm.”
Just keep in mind that Addyi is not in any way the same as Viagra. Viagra is physiological and is taken by men before they have sex. The pill increases the amount of blood flowing into the penis. On the other hand, Addyi is taken every night at bedtime, and that is only to reduce the unwanted side-effects. Addyi works by targeting certain chemicals in the brain, so it is not a “sex pill” as some women believe.
