Maximizing the Post-Approval Safety of Flibanserin: A Role for Regulators, Clinicians, and Patients.
Level 5 - mechanism / opinion, no new human data
Expert commentary and regulatory analysis with no original empirical data
PubMed 26798050 · doi:10.1007/s40264-015-0389-2
What was done
This commentary analyzes the US FDA's August 2015 approval of flibanserin (Addyi) for hypoactive sexual desire disorder in women. It reviews the regulatory history, controversies leading to approval (including two prior rejections, advocacy, and a marginal risk/benefit profile), and the safety measures established under the FDA Risk Evaluation and Mitigation Strategies (REMS) program.
What was found
The abstract provides no numerical data. It identifies key safety hazards, noting that drug-drug interactions and concurrent alcohol use potentiate risks of dizziness, hypotension, and syncope. It outlines that risk mitigation relies heavily on clinician and patient adherence to REMS protocols to avoid off-label hazards.
Why it matters
Flibanserin's approval occurred despite a tenuous risk/benefit profile and substantial safety concerns. This paper highlights the post-marketing regulatory and clinical responsibilities required to prevent serious adverse drug interactions in real-world practice.
Limits
The paper is a narrative commentary and policy analysis offering no original empirical data, quantitative risk measurements, or prospective observational safety outcomes.
Cited by
- context Clinical trials for drugs exclusively prescribed to women are conducted on men because women cannot tolerate the drugs.