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, twice what the market could bear, according to the lawsuit. sales were lifeless as insurers and drug benefit managers balked at covering the drug.
the drug also launched in the u.s. with a black-box warning — the highest kind of 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.