Medication approval journey
aripiprazole (Abilify)
Approved for Schizophrenia, and acute manic and mixed episodes
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?
Efficacy of ABILIFY was established in the following adequate and well-controlled trials: Four short-term trials and one maintenance trial in adult patients... The efficacy of ABILIFY as monotherapy in the acute treatment of manic episodes was established in four 3-week, placebo-controlled trials in hospitalized patients who met the DSM-IV criteria for bipolar I disorder with manic or mixed episodes.
Step 2
The approval
When was it approved, under what application, and by whose review?
- Approved
- November 15, 2002
- Application
- NDA021436
- 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 aripiprazole (Abilify) in Resolv
The app has the full approval journey, the resources behind it, and people working through the same questions.
