FDA approves ‘female Viagra’ with strong warning

Compared to a fake treatment (placebo), Addyi was tied to 0.5 more satisfying sexual events per month on average.

In order to dispense the drug, doctors must complete an online certification process that necessitates counselling patients through the possible risks, while pharmacists must be certified and remind customers not to drink. HSDD patients often feel stress or anxiety surrounding their lack of sexual desire.

Addyi will be the first drug on the market designed to boost women’s libido, or Hypoactive Sexual Desire Disorder, to give it its clinical term.

“We sort of demonstrated the benefits across the studies and characterized the risks”, she says, adding that the most common side effects were dizziness, nausea and sleepiness.

The statement added that prescribers and patients should understand fully the risks that are associated with using Addyi prior to considering treatment.

Patients have been told to discontinue treatment after eight weeks if they do not report an improvement in sexual desire. Viagra targets the physical problem of erectile dysfunction, while Addyi targets the central nervous system and helps increase sexual desire.

Unlike Viagra, that elevates sexual desire in men by increasing the blood flow to the penis, flibanserin affects the neurochemical balances inside the female’s body to propel sexual desires.

Now that the drug Addyi has been approved to treat low libido in premenopausal women, the 34-year-old is eager to see if it works for her. It is very similar to what an antidepressant does to the human brain and cheers it up.

Addyi is taken once a day in the form of a pink pill and regulators said it was only safe for women have not reached menopause.

It however hasn’t been all a smooth ride for Addyi. However, an advisory committee of outside experts voted 18-6 earlier this month to recommend that the F.D.A approve the drug with conditions. Its approval marks a turnaround for the FDA, which previously rejected the drug twice due to lackluster effectiveness and side effects.