EPISODE · Aug 8, 2023 · 24 MIN
Is Off-Label Drug Use Dangerous?
from Druggist For The People · host Donald Schoeff R.Ph.
Send us Fan MailSummary: 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 Questions and comments to [email protected]
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Send us Fan Mail 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. ...
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Is Off-Label Drug Use Dangerous?
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