Medication approval journey
amphetamine (Adderall XR)
Approved for ADHD in children, adolescents and adults
Before changing anything
Stopping abruptly causes withdrawal effects that can be severe
Stopping a stimulant abruptly after regular use commonly causes a crash — fatigue, low mood, heavy sleep. It is not usually dangerous, but it is worth planning rather than improvising.
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?
A double-blind, randomized, placebo-controlled, parallel-group study was conducted in children aged 6 to 12 (N=584)... for three weeks... A double-blind, randomized, placebo-controlled, parallel-group study was conducted in adults (N=255) who met DSM-IV criteria for ADHD... or placebo once daily in the morning for four weeks.
Step 2
The approval
When was it approved, under what application, and by whose review?
- Approved
- October 11, 2001
- Application
- NDA021303
- 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 amphetamine (Adderall XR) in Resolv
The app has the full approval journey, the resources behind it, and people working through the same questions.
