Medication approval journey
methylphenidate (Concerta)
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?
CONCERTA was demonstrated to be effective in the treatment of ADHD in patients who met the Diagnostic and Statistical Manual 4th edition (DSM-IV) criteria for ADHD in the following trials: Three trials in pediatric patients 6 to 12 years old (Studies 1, 2, and 3), One trial in adolescents (13 to 18 years old), Two trials in adults (18 to 65 years old).
Step 2
The approval
When was it approved, under what application, and by whose review?
- Approved
- August 1, 2000
- Application
- NDA021121
- 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 methylphenidate (Concerta) in Resolv
The app has the full approval journey, the resources behind it, and people working through the same questions.
