Medication approval journey
risperidone (Risperdal)
Approved for Schizophrenia in adults
Before changing anything
Stopping abruptly can be dangerous — never do it without medical supervision
Do not stop an antipsychotic abruptly. Abrupt withdrawal can cause rebound or supersensitivity psychosis and withdrawal movement disorders, and relapse risk is highest with the fastest reductions. 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 RISPERDAL in the treatment of schizophrenia was established in four short-term (4- to 8-week) controlled trials of psychotic inpatients who met DSM-III-R criteria for schizophrenia.
Step 2
The approval
When was it approved, under what application, and by whose review?
- Approved
- December 29, 1993
- Application
- NDA020272
- Review
- PRIORITY
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 risperidone (Risperdal) in Resolv
The app has the full approval journey, the resources behind it, and people working through the same questions.
