Medication approval journey
paroxetine (Paxil)
Approved for Major depressive disorder in adults
Before changing anything
Stopping abruptly causes withdrawal effects that can be severe
Stopping or reducing an SSRI too fast commonly causes withdrawal symptoms — dizziness, electric-shock sensations, insomnia, agitation. These are often more severe and far longer-lasting than the "one to two weeks" many people are told. Any change should be a slow, prescriber-supervised taper.
How long the trials actually ran
The gap between how long the trials ran and how long people actually take these medications is the single most important thing on this page. It is not evidence that longer use is unsafe or ineffective. It is evidence that longer use was not what got tested.
The approval, step by step
Step 1
What the approval was actually based on
Which studies did the FDA rely on, how long did they run, and who was in them?
The efficacy of PAXIL as a treatment for major depressive disorder (MDD) has been established in 6 placebo-controlled studies of patients with MDD (aged 18 to 73)... Patients who responded to PAXIL (HDRS total score <8) during an initial 8-week open-label treatment phase were then randomized to continue PAXIL or placebo, for up to 1 year. Patients treated with PAXIL demonstrated a statistically significant lower relapse rate during the withdrawal phase (15%) compared to those on placebo (39%).
Step 2
The approval
When was it approved, under what application, and by whose review?
- Approved
- December 29, 1992
- Application
- NDA020031
- Review
- STANDARD
Step 3
What was added after it was on the market
Which warnings arrived only after millions of people were already taking it?
Step 4
What independent research has found since
What has been learned by people who were not selling it?
Step 5
What still is not known
Which questions you might reasonably have has nobody answered yet?
Open paroxetine (Paxil) in Resolv
The app has the full approval journey, the resources behind it, and people working through the same questions.
