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Carol Eustice

FDA Announces Changes for Long-Acting and Extended-Release Opioid Analgesics

By September 10, 2013

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In an effort to reduce the misuse and abuse of long-acting and extended-release opioid analgesic medications while preserving appropriate access for patients who rely on the drugs to manage pain, the FDA has taken action. The FDA has announced that there will be safety labeling changes and new postmarket study requirements for all extended-release and long-acting opioid analgesics. The updated labeling will state that extended-release and long-acting opioids are "indicated 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 essence, this means that extended-release and long-acting opioids should be prescribed for patients in whom non-opioid analgesics or immediate-release opioids are ineffective, not tolerated, or provide inadequate pain relief. Extended-release and long-acting opioids are not appropriate for as-needed pain relief. The labeling change is designed to more clearly state safety concerns and to encourage appropriate prescribing. Drug companies that manufacture extended-release and long-acting opioids will be required to conduct clinical trials and studies to further assess risks of opioid use. Also, a black box warning will be required on extended-release and long-acting opioids to caution that chronic use during pregnancy can result in neonatal opioid withdrawal, a serious condition that can be life-threatening.

Arthritis patients who take long-acting and extended-release opioid analgesic medications should ask their doctor if the changes will make an adjustment to their current treatment regimen necessary.

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