Summary: Off-label drug use rings of risk, of a doctor gone rogue, of an unknowing patient in danger. But this issue - using drugs approved for one indication for a completely different use - is more common than you would think, and the reasons for this are simple and sensible. This is a look at how an FDA-approved drug may launch in a trajectory for an intended indication, but may find itself in a different orbit: off-label drugs.
Topics:
· Off Label Drug Use (OLDU) 02:00
· Approved Indications 02:45
· Benefit Outweighs Risk 03:25
· Monitoring Drug Usage: Discovering New Uses 04:25
· FDA – Does NOT regulate practice of medicine 05:00
· No Advertising for OLDU 05:45
· Psych/Peds/Pregnant Women OLDU 06:45
· Physician Disclosure 07:00
· Mood Stabilizers (carbamazepine, valproate) 08:25
· Psych/Peds/Pregnant Women 09:10
· Why Not New Approval? 10:25
· Tricyclic Antidepressants (amitriptyline, Imipramine) OLDU 11:45
· Life Threatening Conditions 13:00
· Methotrexate 14:00
· Lantus Insulin 16:30
· Evidence that is accepted w/in profession of medicine 17:25
· Baclofen and Hiccups 18:00
· Hydroxychloroquine 19:00
· Orphan Drugs 20:10
· Emergency Use Authorization 21:25
· Gabapentin 22:15
· Monitor-Monitor-Monitor 22:30
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