19 Aug 2015

Should women welcome a new pill to tackle low libido?

Flibanserin, widely dubbed “female viagra”, is approved for public use by the US drug authority, despite having rejected it twice before. Should women steer clear of a drug critics say is unnecessary?


Manufacturer Sprout Pharmaceuticals says flibanserin, which will be marketed under the brand name Addyi, will treat generalised hypoactive sexual desire disorder (HSDD) in premenopausal women. This form of sexual dysfunction affects around 7 per cent of premenopausal American women according to Sprout.

Just five years ago an FDA advisory committee voted unanimously against approving flibanserin – the second FDA rejection of a drug which was originally developed as an anti-depressant.

But since 2010 a vocal new group called Even the Score (campaigning to “level the playing field when it comes to the treatment of women’s sexual dysfunction”) has vigorously lobbied the FDA ahead of its decision to give flibanserin the go ahead.

Following the FDA decision to approve flibanserin, Sprout Chief Executive Cindy Whitehead said in a statement: “We applaud the Food and Drug Administration (FDA) for putting the patient voice at the center of the conversation and for focusing on scientific evidence”.

But despite the FDA imposing some strong restrictions on the way it should be prescribed, the National Women’s Health Network (NWHN) condemned the decision, saying it believed the FDA’s approval was “influenced by an unprecedented and coercive sponsor-initiated marketing and public relations campaign” adding that “it erodes the integrity and meanigfulness of the FDA’s own standard for approving drugs.”

Sprout’s CEO Cindy Whitehead has acknowledged that her company paid for the travel costs of many of the women who testified at FDA hearings.

Female viagra?

Under the banner of women’s rights, the campaigners argued that if men have viagra, women should not be denied flibanserin.

But flibanserin is not a female viagra. It works in a totally different way.

While men take viagra immediately before sex, women would have to take flibanserin every day. And that could make some of the side effects problematic.

On its own, flibanserin is more sedating than four alcoholic drinks.

The FDA requested an extra safety study of the drug’s impact on users who also drink alcohol. Sprout’s study included just 25 people, and 23 of them were men. The FDA has demanded post-approval trials, and meanwhile has ruled that before prescription “health care professionals must assess the likelihood of the patient reliably abstaining from alcohol.”

Other serious side effects include fatigue, severely low blood pressure and loss of consciousness. The drug’s clinical trials saw a 14 per cent drop-out rate due to adverse effects.

In July 2015 a letter from over 100 health professionals predicted “an epidemic of serious adverse events” if it came on the market and was prescribed to women with cardiovascular problems, or on multiple drugs, or social drinkers.”

How well does it work?

Critics say the benefits do not outweigh the risks.

Compared to a placebo group, women with HSDD taking flibanserin had an additional 0.7 “sexually satisfying events.”

An FDA analysis found between 8-13 per cent of women would see some improvement compared to a placebo, meaning at least 87 per cent would get no benefit at all.

Dr Adriane Fugh-Berman of Georgetown University and PharmedOut, a project that questions the influence of drug companies on medical practice, has condemned the drug as “a mediocre aphrodisiac with scary side effects.”

Is it necessary?

Despite emotional testimony of marital anguish from the witnesses who lobbied the FDA, some critics say that flibanserin is medicalising a normal state of health.

Nicole Dubowitz, of PharmedOut, tweeted “well ladies, look forward to a lifetime of being told to just take a drug if you’re not in the mood”.

Some medical ethicists have gone further, suggesting that HSDD is a case of “disease mongering”, ie creating a disease in order to promote a drug to treat it, and concluded that flibanserin is “a pill for no ill”.

What is HSDD?
HSDD is characterised by low sexual desire causing marked distress or interpersonal difficulty that is not due to an existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.

The authors of an article on flibanserin for a website on psychiatry, Mad In America, conclude: “If Even the Score’s marketing campaign is truly about women’s empowerment, what are they doing to educate women about these serious potential side-effects”.

Sprout Pharmaceuticals has yet to apply for a licence to sell flibanserin in Europe.