Food and Drug Administration oversees the pharmaceutical industry, which includes manufacture, marketing, and sale of medications. Clinical practice by prescribers is NOT regulated by the FDA. The Pediatric Research Equity Act of 2003 allowed FDA to mandate the pharm. companies to research pediatric safety and efficacy of new drugs (at least 2 clinical trials). Drugs that were already used in adults had to show safety data in peditric population in at least a 6-months study. Drugs that received pediatric labeling indication prior to 2003 often simply extrapolated data from adult studies
- For example, haloperidol and chlorpromazine carry extrapolated "FDA approval" for psychosis for children as young as 3 and 1 y.o., respectively, while actual research amounts to only moderate and low quality of evidence for these drugs, respectively.
- Second-generation antipsychotics have higher quality of evidence backing their indication for use in children 5+ (Risperdal), 6+ (Abilify), 10+ (SEroqeul), and 13+ (Zyprexa).
- Duloxetine has FDA indication for treatment of generalized anxiety disorder in children above >7y.o., while SSRIs do not. The evidence for SSRIs is far more superior.
Indication is an illness or condition for which a drug or device is helpful, or "indicated." The Food and Drug Administration (FDA) classifies indications for marketing of drugs in the United States. Indications for drugs can be classified in two categories:
- FDA-approved, also called labeled indications
- Non FDA-approved, also called off-label indications. "off-label" does not mean "inappropriate" for clinical use.
- This means that FDA did not approrve medication's use for marketing, either because it denied the company's request, or, more often, because approval for specific marketing was never requested. (1)
Bipolar Disorder in Adults
|FDA Approval||Acute Mania (alone)||Acute Mania (w Li+ or VPA)||Acute Depression||Maintenance Alone||Maintenance w Li+ or VPA|
|Lamotrigine||+||+ with VPA|
|Zyprexa + Prozac (Symbyax)||+|
(1) Lorberg B., et. al Pediatric Psychopharmocology. JACAAP 2014; 53:7