In Reply Goldstein et al feel we gave disproportionate emphasis to the risks of flibanserin in our recent editorial.¹ We disagree. We also emphasized its lack of benefit.

We also disagree with their characterization that the US Food and Drug Administration (FDA) concluded that flibanserin was both safe and effective. That is not the case. The FDA simply approved the drug, and that only means the FDA concluded that flibanserin's benefits outweigh its harms for the intended use.²

The FDA approved flibanserin over the objection of its own clinical review team. The clinical team leader certainly did not see the drug as safe and effective: 鈥渄espite the strictest risk mitigation strategies that FDA can require, flibanserin 100 mg at bedtime to treat acquired, generalized HSDD in premenopausal women has an overall negative benefit/risk balance and should not be approved.鈥�³ The FDA division director who overruled the review team acknowledged that while they disagreed in judging whether benefits outweighed harms, they agreed on the facts³ that the treatment effects were small and there were dangerous harms.