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Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsFDA announces new labeling rules for opioid painkillers, including oxycodone
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The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities, FDA Commissioner Margaret A. Hamburg said in a statement. Todays action demonstrates the FDAs resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain.
The agency said the new labeling language will indicate that the drugs are intended for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
In addition, it will make clear that because of the risks of addiction, abuse and misuse even for patients who use the drug as directed opioids should be used only for people for whom other treatments are not sufficient.
These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs, Douglas Throckmorton, deputy director for regulatory programs in the FDAs Center for Drug Evaluation and Research, said in a statement.
http://www.washingtonpost.com/national/health-science/fda-announces-new-labeling-rules-for-opioid-painkillers-including-oxycodone/2013/09/10/b722281a-1a30-11e3-a628-7e6dde8f889d_story.html?Post+generic=%3Ftid%3Dsm_twitter_washingtonpost
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FDA announces new labeling rules for opioid painkillers, including oxycodone (Original Post)
The Straight Story
Sep 2013
OP
[RAND MODE] This is just another erosion of liberty and a demonstration of...
ReverendDeuce
Sep 2013
#1
ReverendDeuce
(1,643 posts)1. [RAND MODE] This is just another erosion of liberty and a demonstration of...
... just how tyrannical this Obama regime is! Blah blah blah blah.
(Sorry my post lacks any substance, I am just particularly sick of libertarianism today.)
cali
(114,904 posts)2. I fit into this category unfortunately
severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Now though, after 25 years of hit or (mostly) miss pain relief, I am getting excellent results from Fentanyl patches.