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Comment & Response
September 2016

Appropriate Perspective and Context for Newly Approved Medications, Including Flibanserin—Reply

Author Affiliations
  • 1Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire
  • 2Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
JAMA Intern Med. 2016;176(9):1405. doi:10.1001/jamainternmed.2016.3898

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

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