Over the last few years as flibanserin slogged its way toward FDA approval, there has been talk about the inadvisability of mixing the drug and alcohol. However, since the FDA gave the medication a conditional thumbs-up in August 2015, the potentially dire consequences of alcohol’s interaction with Addyi — as the drug has now been branded — are coming under greater scrutiny.
So concerned was the drug regulatory agency about the perils of mixing alcohol and Addyi that it approved the medication under its REMS (Risk Evaluation and Mitigation Strategy) program and ordered a black box warning highlighting those very dangers. Drugs in FDA’s REMS program can be prescribed and dispensed only by physicians and pharmacists who have taken a brief training course that emphasizes the importance of frankly discussing with patients the dangers associated with such medications.
Addyi REMS Training Slides
As evidence of FDA’s concerns about Addyi’s interaction with alcohol, its training slides for the drug counsel prescribers and pharmacists as follows:
- “Patients must not take Addyi unless they can abstain from alcohol use for the full duration of the treatment.
- “Prescribers need to evaluate a patient’s ability to abstain from using alcohol.
- “Prescribers and Pharmacists must counsel their patients on the increased risk of hypotension and syncope [loss of consciousness] with Addyi due to an interaction with alcohol and the need to abstain from alcohol.
- “The Addyi REMS Program Patient-Provider Agreement Form is an important tool for health care providers to use with patients.”
Patients signing the form also promise that they will lie down right away if they feel lightheaded or dizzy and will seek medical help if such symptoms persist. The form also stipulates that patients must take Addyi only at bedtime and must notify their health care provider as soon as possible if they should faint while using the drug.
Bay Area OB/GYN Has Questions
Jennifer Gunter, M.D., a San Francisco-based OB/GYN, called attention to questions about the Addyi-alcohol interaction in a blog posted to her website only days after FDA’s approval of the drug. She wrote that she was “underwhelmed” by the so-called REMS training that is a prerequisite for health care providers and pharmacists seeking to prescribe and dispense the drug.
The training program consisted of a review of 12 PowerPoint slides, responses to a couple of questions, and the submission of a form. Dr. Gunter said it took her all of five minutes to complete the program. The training focused almost entirely on the dangers of mixing alcohol and Addyi “and did not mention how to screen, or limiting prescribing for eight weeks to assess efficacy, or interactions with other drugs.”
Study Participants Mostly Male
Perhaps most alarming of all, Dr. Gunter disclosed that the safety of Addyi with alcohol “was studied in 23 men and two women, for a drug ONLY [the emphasis is Dr. Gunter’s] to be prescribed for women.” Pointing out that men generally have a higher tolerance for alcohol than women, the good doctor was incredulous to find that some of the healthy test volunteers, most of them men, required treatment for a sharp drop in blood pressure after mixing Addyi and alcohol.
Dr. Gunter was not the only medical professional taken aback by the news that men made up 92 percent of the study population on the investigation into the interaction of alcohol with a drug designed exclusively for use in women. Carolyn M. Mazure, Ph.D., director of women’s health research at Yale Medical School, was equally aghast, saying that “once again we are through the looking glass.” Mazure went on to say that “there is no valid reason to ignore the well-established biological and behavioral differences between men and women when conducting biomedical research. Yet it continues to happen.”
Men More Willing to Enroll
When asked about the makeup of the study group, Sprout Pharmaceuticals said that the study, designed with help from the FDA, required participants to drink the equivalent of a half bottle of wine on an empty stomach in a 10-minute period before taking Addyi. “More men than women agreed to enroll in this kind of study,” according to a Sprout spokesperson.
Sprout, a small pharmaceuticals company based in Raleigh, North Carolina, purchased the rights to flibanserin from German drugmaker Boehringer Ingelheim after the latter’s petition to market the drug was rejected by the FDA. Sprout, too, was turned down on its first attempt to win approval for the drug but stuck with it, conducting additional tests recommended by the regulatory agency.
Persistence Pays Off
Sprout’s persistence paid off, and in June 2015, an FDA advisory panel voted 18-6 to recommend approval of the drug. The agency took its advisers’ recommendation and on August 18, 2015, approved the medication, subject to the conditions discussed earlier. Less than 48 hours after the FDA handed down its decision, Quebec-based Valeant Pharmaceuticals paid $1 billion to acquire Sprout, which now operates as a division of Valeant.
Addyi officially hit the market on October 18, 2015, two months after getting the green light from the FDA. During the long and difficult struggle to win approval for the drug, its supporters spoke often of the pent-up demand for a drug that could treat hypoactive sexual desire disorder, or HSDD, the most common form of female sexual dysfunction.
Addyi Off to Slow Start
According to a January 2016 report by Pittsburgh Post-Gazette reporter Adam Smeltz, only about 1,000 prescriptions for Addyi were filled during the drug’s first two months on the market. So it seems that much of the demand for a drug like Addyi remains pent-up. Some women may have been put off by the FDA’s stern warnings about Addyi’s possible side effects, while others may prefer to see how others do on the drug before getting it for themselves.
Addyi’s less than spectacular sales performance in its first few months on the market stands in sharp contrast to the male rush to buy Viagra when that impotence drug was introduced in 1998. In the first week that Viagra was available, more than 36,000 prescriptions were written for the little blue pill.
Not at All Like Viagra
Although Addyi has sometimes been referred to as “female Viagra” or “pink Viagra,” it has very little in common with the male erectile dysfunction medications. While they work by optimizing blood flow to the penis, facilitating the erectile process, Addyi targets brain chemistry. Unlike Viagra, which is taken as needed, Addyi must be taken daily, and it may be a few weeks before its effects, if any, begin to be felt.
If you’d like to read additional articles about Addyi and related topics of interest to health consumers, check out our blog.
Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.
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