Citizen petition: Sexual side effects of SSRIs and SNRIs
David Healy
International Journal of Risk & Safety in Medicine2018
Summary (paraphrased)
This is the published text of a citizen petition asking the US FDA to require boxed warnings and label changes for all SSRI and SNRI products regarding persistent sexual dysfunction after discontinuation. The petition marshals the history of regulatory signals: a 1991 UK report of enduring dysfunction, Dutch pharmacovigilance (Lareb) case series, early case literature, the 2011 Prozac label amendment, and DSM-5's acknowledgment that SSRI-induced sexual dysfunction can persist. It documents how early trials undercounted sexual side effects and how post-marketing evidence forced regulators' attention. The same petition, filed in parallel in Europe, led the EMA to add a persistence warning to antidepressant labels in 2019.
Why it’s in the corpus
The regulatory document behind the 2019 EMA label change on persistent post-SSRI sexual dysfunction. Essential for the corpus's regulatory/history axis; rich bibliography of early PSSD evidence. (Free full text on PubMed Central: PMC6004927.)
Related records
- Gray literature
Seven drug regulators, including the EU, UK, and Canada, have warned since 2019 that antidepressant-linked sexual side effects can persist for years after the drug is stopped. The US hasn't.
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