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- Title
Addressing Prescription Opioid Overdose.
- Authors
Jones, Christopher M.; Lurie, Peter; Woodcock, Janet
- Abstract
The article discusses the controversy over the U.S. Food and Drug Administration's (FDA) approval for Zohydro ER, a hydrocodone bitartrate extended release product. Topics discussed include the product as an alternative for patients who require pain management, criticism against the FDA for approving the drug with the increase in opioid overdoses and a recommendation against approval by an advisory committee and the FDA's claim that the drug met its safety and efficacy standard for approval.
- Subjects
DRUG approval; PHARMACEUTICAL policy; OPIOID analgesics; HYDROCODONE; PAIN management; UNITED States. Food &; Drug Administration
- Publication
JAMA: Journal of the American Medical Association, 2014, Vol 312, Issue 17, p1733
- ISSN
0098-7484
- Publication type
Opinion
- DOI
10.1001/jama.2014.13480