‘Viagra for women’ pill approved

But some experts voice alarm over lack of alcohol restriction

anada has approved the first “Viagra for women” pill — and, to the alarm of some experts, loosened restrictions around alcohol that have contributed to the drug’s lacklustre sales in the United States.

Health Canada says Addyi’s safety when mixed with booze was originally tested in a single study involving almost entirely men, and that a more recent women-only study suggests the drug doesn’t interact as badly with alcohol as believed.

In Canada, the libido pill will come with a warning to women to “limit” their alcohol consumption. That’s in stark contrast to the U.S., where the drug is only available under restrictions. Women there are required to promise they’ll abstain from alcohol while on the drug because of risks of severe low blood pressure and fainting.

“I’d be shocked with the alcohol limits having been loosened (in Canada) as every presentation I’ve ever seen on Addyi has come with very strict instructions to abstain completely,” University of British Columbia’s Lori Brotto, an international leader in female sexual desire, said in an email.

Addyi is the first prescription drug in the world designed to treat hypoactive sexual desire disorder, a controversial diagnosis some say pathologizes women for not fulfilling a certain sexual norm. Critics have also argued Addyi isn’t meaningfully superior to placebos, producing, on average, one extra “sexually satisfying event” per month.

Unlike Viagra, which works on the mechanics of erections by improving blood flow to the penis and is taken on an as-needed basis, Addyi is said to “adjust” brain chemicals involved in sexual interest and desire, as long as women take it every day. The exact way in which it works isn’t known. The drug had been under review by Health Canada for more than two years. The federal agency issued a “notice of compliance” late last month, the Post learned. The U.S. Food and Drug Administration twice rebuffed Addyi before granting approval in 2015, and only after lobbying from a “grassroots” campaign called Even the Score — funded by Addyi’s makers, Sprout Pharmaceuticals — that accused the regulator of being sexist for approving sex medicines for men, but not for women.

SHOCKED WITH THE ALCOHOL LIMITS ... LOOSENED.

Days after the FDA’s green light, beleaguered Quebec drug giant Valeant Pharmaceuticals bought Sprout and its sex drug for US$1 billion.

Then, last November, in a bizarre twist, Valeant gave Sprout back to its former shareholders in exchange for a six-per-cent royalty.

The giveback followed a lawsuit launched by Sprout’s former investors alleging Valeant seriously botched marketing the pill in the U.S. Valeant priced Addyi at US$800 per month. Sales were lifeless as insurers and drug benefit managers balked.

The drug also launched in the U.S. with a black-box warning — the highest alert — saying Addyi, when used in combination with alcohol, increases the risk of severe hypotension (low blood pressure) and syncope (loss of consciousness). “Do not drink alcohol if you take ADDYI,” warns the medication guide.

The caution was based on the study that involved 25 people — 23 of them men — administered Addyi along with the equivalent of two to four glasses of wine consumed over 10 minutes in the morning. Health Canada told Sprout that data was insufficient, given it involved almost entirely men, and asked for an additional booze-interaction study, this time in women only.

In the newer study, “the effects on blood pressure related to alcohol were actually slightly less than in the previous study,” said Dr. Supriya Sharma, Health Canada’s chief medical adviser.

The Canadian drug monograph still comes with a precaution that mixing alcohol with Addyi increases the risk of low blood pressure and fainting. However, instead of abstinence, doctors are told to caution women against “excessive alcohol intake” and recommend they limit their consumption “until they know how Addyi affects them.” However, women with low blood pressure should never drink while taking the libido pill, it says.

In the patient pamphlet, women are also advised to “be careful if you drink alcohol while taking ADDYI” and to limit their drinks. “When we’re talking about limiting, we would say limit to one drink, like a standard size drink, over the course of two to three hours,” Sharma said.

Addyi is meant to be taken once a day, at bedtime only. The drug is dosed at bedtime in case women faint. Other potential side effects include vertigo and nausea. “We believe there is an indication, a use for this medication,” Sharma said. But “it is limited ... and there are lots of warnings and precautions.”

Thea Cacchionio, a University of Victoria professor who testified against Addyi before the FDA, called the easing of the warnings around drinking “completely unethical.”

“Health Canada has done a real disservice to women who may not be educated about how little the drug works as compared to placebo, and who may find themselves in a situation where they experience dizziness or loss of consciousness or a feeling of sedation — which couldn’t be a worse combination when we’re talking about a drug linked to sex,” Cacchioni said.

Sprout did not respond to calls or email messages from the Post.

BE CAREFUL IF YOU DRINK ALCOHOL WHILE TAKING ADDYI.