Medication approval journey
lithium (Lithobid)
Approved for Acute manic or mixed episodes of bipolar I disorder in patients aged 7 to 17
Before changing anything
Stopping abruptly can be dangerous — never do it without medical supervision
Do not stop abruptly. Stopping lithium suddenly is associated with rebound mania and increased suicide risk. Several drugs in this group are also anticonvulsants, and stopping them abruptly can trigger seizures. Any change should be prescriber-supervised.
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 safety and efficacy of lithium as a treatment for acute manic or mixed episodes of bipolar I disorder in pediatric patients (ages 7 to <=18 years) was demonstrated in an 8-week, randomized, placebo-controlled, parallel group study (NCT01166425). In this study, 81 patients with a Young Mania Rating Scale (YMRS) score of 20 or more were randomized to receive lithium or placebo in a 2:1 ratio.
Step 2
The approval
When was it approved, under what application, and by whose review?
- Approved
- April 6, 1970
- Application
- NDA016782
- 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 lithium (Lithobid) in Resolv
The app has the full approval journey, the resources behind it, and people working through the same questions.
