By Richard Halstead The Marin Independent Journal, Novato, Calif.
If you drink don't drive and, if you're a woman, also don't take Addyi, the new medication approved by the U.S. Food and Drug Administration earlier this month for treating low libido in women.
That's the message that women need to hear loud and clear from their physicians, says Dr. Jennifer Gunter, a Kaiser Permanente OB/GYN who lives in Mill Valley.
Gunter said she was astounded to discover recently that a crucial study of how Addyi affects women who have consumed alcohol was conducted using mostly men.
"I'm sure I swore," Gunter said. "How is this possible?"
Gunter made the discovery after reading the "Risk Evaluation and Mitigation Strategy" issued by Addyi's manufacturer, Sprout Pharmaceutical. The FDA requires companies to issue a safety strategy to doctors and pharmacists when a new drug has known or potentially serious risks associated with its use.
The stated goal of the Addyi evaluation was to mitigate the increased risk of severely low blood pressure and fainting due to an interaction with alcohol.
Mostly men The evaluation states that the alcohol interaction study was conducted with 23 men and two women.
"So basically there is no safety data on the effects of women using alcohol and Addyi," Gunter said. She says what is particularly worrisome is the demonstrative effects that the interaction had on this group of mostly young, healthy men. Women metabolize alcohol differently than men.
"On average, women are more likely to feel the effects of alcohol at a lower dose," Gunter said.
Study participants were required to drink the alcoholic equivalent of a half a bottle of wine within 10 minutes on a nearly empty stomach before taking Addyi. Four of the 23 subjects either experienced abnormally low blood pressure or temporary loss of consciousness. The REMS states, "Therapeutic intervention was needed in some cases."
"Since some healthy men fainted and needed intervention," Gunter said, "you can only be concerned that loss of consciousness could certainly be a side effect for women were they not to follow medical advice and take alcohol with this medication. There is no margin of error."
No one with Sprout Pharmaceutical was available for comment. Regarding the makeup of the alcohol study, company spokeswoman Lissa Pavluk said in a statement, "More men than women agreed to enroll in this kind of study."
Risk evaluation The science journal, Nature, has reported that the FDA is requiring Sprout to conduct three more alcohol interaction studies after the drug goes on sale.
Gunter said women are underrepresented in most biomedical research because pregnancy and menstrual cycles are seen as complicating factors.
"That is a huge problem" but somewhat understandable, Gunter said. In the case of a drug like Addyi, designed exclusively for women, she said, "You'd think a little bit more effort could have put into recruiting women."
Addyi's risk evaluation states that women who take the drug need to understand that they must not drink alcohol while taking the drug. Gunter says that will be easier said than done since Addyi must be taken daily to be effective.
"Most women are floored by that," Gunter said. Many women, she said, think Addyi works like Viagra -- "you take the drug and two hours later you're calling your boyfriend."
Gunter questions how many women will be willing to forgo alcohol -- itself a mild aphrodisiac -- for a drug that has limited effectiveness.
Side effects The FDA twice declined to approve Addyi, citing side effects and marginal effectiveness, before changing its mind this month. Gunter said in early studies 30 to 40 percent of women who took Addyi responded versus 15 to 30 percent who were administered placebos. Those who did respond reported about one additional satisfying sexual encounter per month.
In addition, Gunter said the participants in these studies were women in stable monogamous relationships, who liked their partners, weren't depressed and were already having sex three to four times a month. She said that doesn't fit the description of the patients she sees with libido complaints.
Gunter said the idea of a pill to boost libido seems to ignore an evolving understanding of female sexuality, which recognizes that a woman's sexual desire is more receptive than spontaneous, as in a man.
"I think a lot of people are under the misapprehension that women are supposed to feel horny all the time," Gunter said. But Dr. Anne Wolff, a clinical psychologist and licensed sex therapist based in Larkspur, questions that notion. "Women have as strong a libido as men do," Wolff said.
"If a woman feels she wants increased libido, it is certainly worth trying if her doctor approves. I would strongly recommend it," Wolff said.
Wolff said taking the medication could have a psychological, as well as a physiological effect. "They would feel they are doing something about it," she said.
But Wolff emphasized that the desire for increased sexual desire should come from the woman requesting the medication, not her partner.
She said, "It has to come from within the person, from their own heart."