Consumer Fraud?

"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."
Dr.Lori Brotto, regional psychologist, Tri-Cities Sexual Health Services, British Columbia

"The effects on blood pressure related to alcohol were actually slightly less than in the previous study."
"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."
"We believe there is an indication, a use for this medication. [But] it is limited ... and there are lots of warnings and precautions."
Dr. Supriya Sharma, chief medical adviser, Health Canada

"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."
Thea Cacchionio, professor of gender studies, University of Victoria 

The Food and Drug Administration on Tuesday, Aug. 18, 2015, approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.   AP Photo/Allen G. Breed

What good news! "Pink Viagra" is finally available to women in Canada, thanks to Health Canada giving it the all-clear! Women who need it, will finally get the boost to their libido they've been hungering for. Health Canada held off on its approval since there was only one study undertaken to assess its effect when taken with alcohol; and that study tested men; for a female-centric drug.... So a more recent women-only study was done and its result reassured Health Canada that the drug's interaction with alcohol, while noted, was not quite as awful as previously believed.

Once on pharmacy shelves, the product will present with a warning that women 'limit their alcohol intake'. In stark contrast to the American market where the drug is restricted and women are required to abstain completely from alcohol, while using the drug, reflecting the medical-health risks they face of severe low blood pressure and fainting. Since this is a drug that must be taken daily to be effective, quite unlike the men's Viagra [taken only when needed], alcohol abstention is complete.

As the first prescription drug ever designed as a treatment of hypoactive sexual desire disorder [a diagnosis which some experts claim pathologizes women found not to reflect a typical 'norm'], its critics claim it is, in fact, no more superior in functionality than a placebo in producing one extra 'sexually satisfying event' each month. While Viagra works by boosting blood flow to the penis, Addyi's effect is to 'adjust' brain chemicals directing sexual interest and desire; a biomechanism not yet quite fully understood.

The U.S. Food and Drug Administration for its part, had rebuffed Addyi twice before approval was granted in 2015 in the wake of lobbying from a group calling themselves Even the Score, which just happened to have its activities funded by the makers of Addyi, Sprout Pharmaceuticals. The lobbying group lodged an accusation that the regulator was sexist in approving sex medication for men, but not for women. And when the drug was launched in the U.S. a black-box warning came with it.

That  high-alert warned that when used in combination with alcohol, Addyi increases the risk of severe hypotension and syncope [loss of consciousness]: "Do not drink alcohol if  you take ADDYI" the alert warned, as an uncompromising guide. Based on a study of 25 people of whom 23 were male, the study administered Addyi with the equivalent of two to four glasses of wine taken over a ten-minute period in the morning.

Meant to be taken once a day at bedtime only [in case women faint; additional side effects include nausea and vertigo], the Addyi pills didn't come cheap. A month's supply was priced to set the user back $800, a cost that many insurers are reluctant to pick up. and because drug benefit management plans and insurers balked at the price, understandably sales of Addyi in the United States were rather lacklustre.

Dr. Cacchionio, who had testified against Addyi before the FDA, characterized as "completely unethical", any easing of warnings around drinking while using Addyi. And in the Canadian drug monograph including the precaution that mixing alcohol with Addyi increases risk of low blood pressure and fainting, prescribing doctors are encouraged to merely caution women against "excessive alcohol intake", not recommend complete abstinence.

Treatment with flibanserin, on average, resulted in one-half additional satisfying sexual event per month