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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
Woloshin S, Schwartz LM. Appropriate Perspective and Context for Newly Approved Medications, Including Flibanserin—Reply. JAMA Intern Med. 2016;176(9):1405. doi:10.1001/jamainternmed.2016.3898
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