A drug billed as the “female Viagra” has largely failed women because it is only modestly effective, yet comes with a host of side effects, according to a women’s health group.
August marks one year since the FDA approved Addyi (flibanserin) for female sexual dysfunction following a major lobbying effort from its manufacturer, Valeant Pharmaceuticals. In fact, the FDA rejected the pill twice before finally approving it.
But in a new report card on the drug, the National Women’s Health Network (NWHN) gave Addyi a “D” grade for practicality and provider education.
For example, the organization noted that studies conducted on Addyi demonstrated that the medication led to little or no boost in sexual libido. Clinical trials found that 9 out of 10 women experienced no increase in sexual desire while taking the drug compared to a placebo.
NWHN also says that the benefit/risk ratio for Addyi is poor, especially considering the drug contains a “black box” warning –- the strongest possible from the FDA –- due to a side effect involving severe, sudden drops in blood pressure that can lead to loss of consciousness for prolonged periods. In addition, women should not drink alcohol while on the drug.
Because of these safety concerns, the FDA required Valeant to develop a plan, known as a Risk Evaluation and Mitigation Strategy, that requires doctors and pharmacists go through training about the risks associated with Addyi. However, NWHN criticizes the training since it is only a PowerPoint presentation and a 4-question test.
NWHN also notes that post-marketing studies on the long-term effects of taking Addyi, including one on the effect of the drug in pregnant women, are still pending.
Despite the hoopla surrounding female viagra Addyi’s approval, the drug, from a financial standpoint, has been a disappointment for Valeant, with sales far lower than expected.
