Addyi Recall Predicted By Consumer Advocates Due to Health Risks With “Female Viagra”

The prominent consumer watchdog group Public Citizen is criticizing the FDA’s recent decision to approve the drug Addyi, which has been referred to by some in the media as the “female Viagra.” As more individuals become exposed to the health risks associated with the medication, the group indicates that the FDA will likely end up pulling Addyi from the market within a few years.

The FDA announced the approval of Addyi (flibanserin) earlier this month for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The agency previously rejected attempts to introduce the medication in 2010 and 2013, due to questions about whether the benefits justify the risks.

In a press release issued on August 19, Public Citizen indicated that once enough women have ben seriously harmed by the “irreversible, or life threatening injuries” that have been linked to the medication, an Addyi recall will likely be issued.

According to the FDA, the drug can cause severely low blood pressure, known as hypotension, as well as loss of consciousness, referred to as syncope, particularly when taken with alcohol or certain medications, such as Prilosec, Depakote and even grapefruit juice, which are all known as strong CYP3A4 inhibitors.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” FDA’s Center for Drug Evaluation and Research (CDER) director, Dr. Janet Woodcock, said in the agency’s announcement of the approval. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

Despite the safeguards, the founder and senior advisor of Public Citizen’s Health Research Group, Dr. Sidney Wolfe, indicates that the approval “recklessly disregards the worrisome risk information” the FDA was provided at a June 4 meeting of its advisory committee.

Public Citizen notes that the agency’s own analysis indicates that use of the drug added only one-half to one additional “satisfying sexual encounter” per month to a woman’s life when compared to a placebo.

“It is unconscionable that the FDA does not have the courage to prevent such damage from a drug with such a high ration of risks to benefits, ” the Public Citizen press release states. “Unfortunately, we haven’t heard the last of this drug. Expect future news to include stories of women who are harmed needlessly by flibanserin and the eventual agency call for the manufacturer to pull it from pharmacy shelves.”