Medication approval journey
mirtazapine (Remeron)
Approved for Major depressive disorder in adults
Before changing anything
Stopping abruptly causes withdrawal effects that can be severe
Withdrawal effects vary a lot across this group but are real. Any change should be prescriber-supervised rather than abrupt.
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 REMERON as a treatment for major depressive disorder was established in 4 placebo-controlled, 6-week trials in adult outpatients meeting DSM-III criteria for major depressive disorder... In a longer-term study, patients meeting (DSM-IV) criteria for major depressive disorder who had responded during an initial 8 to 12 weeks of acute treatment on REMERON were randomized to continuation of REMERON or placebo for up to 40 weeks of observation for relapse.
Step 2
The approval
When was it approved, under what application, and by whose review?
- Approved
- June 14, 1996
- Application
- NDA020415
- 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 mirtazapine (Remeron) in Resolv
The app has the full approval journey, the resources behind it, and people working through the same questions.
