Prescription drug Addyi’s adverse effects may include breast cancer, a study suggests
An October 2015 article on LatinosHealth.com describes the pharmaceutical formerly known as flibanserin (brand name Addyi) and the controversies surrounding it before and after its August 2015 US Food and Drug Administration approval.
The manufacturer and marketer of the drug has made sure to employ the phrase “female Viagra” when discussing the little pink pill, even though, unlike the little blue pill, it does not treat a physical condition. Instead, as the website notes, it is “touted to help fight low libido in women.”
The drug originally failed to get approval from the FDA, because it lacked effectiveness and caused fatigue, nausea, and dizziness. Despite the fact that it still lacks effectiveness, still causes those adverse effects, and newer concerns have emerged about a link to breast cancer, Addyi was approved after a massive, often theatrical, lobbying effort by the pharmaceutical company and other stakeholders.
The drugmaker, who held a debt of $50 million to private investors for the publicity campaign for its one and only drug, rounded up stakeholders and “supporters” from all over the country to accuse the FDA of being sexist. Regulators were refusing, they argued, to fast-track approval of the “female Viagra” while previously having done so for… you guessed it, Viagra. They even set up an ersatz activist group called, unsubtly, “Even the Score.”
Surely, the FDA would not cave to this disingenuous, childish approach. Well, it did.
The FDA says it has imposed “stern warnings” to be issued with the prescriptions. According to LatinosHealth.com, Addyi’s warning label states that the sexual libido drug must not be taken with alcohol, which increases the fainting risk. The warnings leave it up to doctors and their patients, both of whom have interests which may sometimes trump such warnings.
“[Flibanserin’s] approval provides women distressed by their low sexual desire with an approved treatment option,” said Dr. Janet Woodcock of the FDA’s Center for Drug Evaluation and Research, according to the website.
But, according to Dr. Holly Thacker of the Cleveland Clinic, while Addyi is an option for women who are experiencing sexual dysfunction, it is not a treatment. “It doesn’t treat all sexual dysfunction, it won’t help all women with sexual problems, but it will have a role in the therapy,” Thacker told LatinosHealth.com. “Just like with any medication, adult women in conjunction with their physician can make an informed decision about whether this is an appropriate therapy for them.”
They can make an informed decision, but will it be a responsible decision? Addyi is actually most similar to Viagra in its potential for recreational use and abuse. So, while the pharmaceutical corporation rakes in billions, users of Addyi—like users of Viagra—will push aside warnings of adverse effects in order to get “a little help in the bedroom”—and the drugmakers are fully aware of that.
Meanwhile, the breast cancer connection will only be explored if and when Addyi users are found, via cancer diagnoses, to be at higher risk than general populations.