Female ‘Viagra’ drug finally approved by FDA – but is it safe?

 AP Photo/Allen G. Breed

AP Photo/Allen G. Breed

The first prescription drug designed specifically to target impotence in women has finally been approved by the Food and Drug Administration this week.

Addyi has been formulated to increase sexual desire in females, and is being dubbed ‘Viagra for Women’. The drug has been a long time in formulation, as companies hoped to emulate the success of Viagra, but safety issues have so far thwarted any progress to market.

In fact, the FDA has already rejected the drug twice, back in 2010 and 2013, due to the risks involved when patients are taking other medication, and when it is combined with alcohol.

To this effect, the box will have a warning on it, alerting doctors to the dangers when prescribing with other medications, which include antifungals to treat yeast infections. Patients can suffer low blood pressure and fainting fits, particularly if the pill is taken with alcohol.

“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” said Dr. Janet Woodcock, director of the FDA’s drug center, in a statement.

To ensure maximum safety, the FDA has issued a safety plan, in which doctors can only prescribe Addyi after they have completed an online certification process. This is so that they can then advise potential users of the drug of the risks involved in taking it.

However, critics of the drug say that this is not enough, and point out that the risks far outweigh any benefits. The side-effects drowsiness and dizziness, and opponents reiterate that the drug was also rejected because of lacklustre results regarding efficacy.

There’s also the question of spontaneity when taking the drug.

“This is not a drug you take an hour before you have sex. You have to take it for weeks and months in order to see any benefit at all,” said Leonore Tiefer, a psychologist and sex therapist. Tiefer felt so strongly about Addyi that she organised a petition last month which asked the FDA to reject the drug.

The road to getting a female impotence drug to the consumer has been undoubtedly rocky for Sprout Pharmaceutical, the company that manufactures Addyi.

Whilst male drugs that target a lack of libido appear to be prevalent and have marked results, the same cannot be said for female impotence drugs.

Addyi was twice rejected due to very poor results, showing a minimal benefit that did not outweigh the risks. But Sprout then campaigned in a different direction. Instead of refining the drug, and obtaining better results, they focused on gender inequality, and launched a campaign called Even the Score, citing over 26 FDA approved drugs for males, but none for women.

Sprout and its advocators argued that women have been overlooked time and time again, when it comes to sexual health. The FDA showcased safety concerns and minimal benefits on their side.

The lack of impotence drugs for women became a women’s rights issue last year, with more than 60,000 supporters signing a petition which was handed to the FDA.

“Women deserve equal treatment when it comes to sex,” Even the Score states online.

At the FDA meeting in June to discuss the drug, the FDA was inundated with calls from the public to approve Addyi. The Even the Score campaign was frequently mentioned, and the FDA was vastly outnumbered.

Eventually, it is thought, particularly from political activists such as Tiefer, that this pressure from feminist lobbyists funded by Sprout, persuaded the FDA to give approval to Addyi.

“Women are grasping, and I feel like we need to offer them something that acknowledges that, and that we can feel safe and comfortable with,” said Dr. Cheryl Iglesia, a surgeon and official with the American Congress of Obstetricians and Gynecologists.

Addyi is known generically as flibanserin and works differently to usual sexual impotence drugs. Typically they target biological functions such as increased blood flow and hormones. Addyi is the first drug that acts on the chemicals in the brain, affecting mood and appetite.

So far, clinical trials have not showed results to shout about. Women who have taken the drug report one extra ‘sexually satisfying event’ per month, and have increased sexual desire.

The drug will cost women with insurance around $30 and $75 per month for Addyi, depending on their coverage.

Addyi has been specifically approved for premenopausal women with hypoactive sexual desire disorder; this is a lack of sexual appetite that causes distress.

However, there are still some psychologists who would argue that low sex drive should not be considered as a medical problem.

Source: Huffington Post

 

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