FDA Approval of Addyi Sparks Debate

Is the controversial new drug touted as female Viagra cause for celebration or concern? Does the little pink pill represent “girl” power, or is it a shortsighted remedy for sexual dysfunction in women? Do its benefits outweigh its risks? Questions such as those and a flurry of others have made medical news in the months following the Food and Drug Administration’s approval of flibanserin, marketed as Addyi.

Touters of the medication call it a coup for premenopausal women with low libidos who are worried about their marital relationships. Such a demographic is significant. According to the National Institutes of Health, prevalence of low libidos in premenopausal women averages in the 26-percent range and increases to the 52-percent range in menopausal women.

Dr. Elizabeth Kavaler, a New York City urologist, said Addyi will benefit patients with hypoactive sexual desire disorder and its distressful symptoms.

“I am grateful that we have something to offer these women,” Kavaler said in a Newsweek article.

The use of alcohol is highly contraindicated while taking Addyi due to increased risks of syncope and hypotension.

Psychologist Kim Wallen, a professor at Emory University in Atlanta, described Addyi as an “historic milestone that may open the door to more drugs targeting desire in men and women” in an NBC News story.

Opponents of the medication point to the fact that the FDA twice rejected it prior to signaling the OK. They cite its adverse side effects, which include dizziness, drowsiness, fainting and low blood pressure. Addyi is not to be taken with alcohol of other types of birth-control prescriptions because they are contraindicators that exacerbate the side effects.

“…the FDA’s decision is certain to join other controversial regulatory decisions at the intersection of science, policy, and advocacy,” states a JAMA article.

The National Women’s Health Network made a stance against Addyi, separating itself from other feminist organizations that say the FDA approval, which took place in August 2015, marked a first for a drug that helps ease HSDD.

“I’m a pro-sex feminist, but I believe that advocating for women’s health means finding solutions for women’s sexual problems that are safe and effective,” Cindy Pearson, executive director of the advocacy group, told The Washington Post. “That hasn’t happened. Not yet.”

Consumers taking Addyi are encouraged to contact the FDA in the event of bad reaction by calling (800) 332-1088 or visiting www.fda.gov/medwatch.