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Beyond the Headlines: What the FDA Decisions on Extended-release and Long-Acting Opioids Mean for People With Pain
Date:9/17/2013

se, and suggested that industry players work together to do so. The FDA wrote that it had found no "adequate and well controlled" studies beyond 12 weeks. "Everyone agrees -- or should -- that 'Support long-term studies' should be the rallying cry," Webster said.

The label indication will now change from "moderate-to-severe pain" to "severe enough" to warrant ER/LA opioids. AAPM supports the change as appropriate, believing it will encourage more judicious prescribing, which should benefit patient safety and -- ultimately -- public safety.

"To say the pain must be severe enough to indicate treatment, encourages evaluation of the individual patient on important factors beyond what a pain scale score can show," Webster said. "That distinction, although emphasized by the FDA, was lost in the reporting by some media outlets."

Furthermore, the FDA now says these medications may be used only when alternative therapies would be inadequate, which fits with AAPM's tenet that long-term opioid therapy should be limited to patients whose benefit from it outweighs potential harm. It should be noted, however, that FDA did not require patients to fail alternative therapies first, regardless of the severity of pain or the type of pain involved. Instead, a clinician must assess each patient's risk, and then monitor therapy closely.

The FDA also did not impose a daily dose limit of 100 mg morphine equivalents, nor did the FDA limit treatment duration to 90 days, citing lack of scientific basis for those proposals.

Areas that need further attention, according to AAPM leaders, include better information on the role played in opioid-related overdoses by methadone and by frequently found co-intoxicants, such as benzodiazepines and antidepressants. Furthermore, the FDA did not specifically address the impacts of long-term opioids on hormonal and immune systems in its call for post-approval research.

Full information on the labeling changes and
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SOURCE American Academy of Pain Medicine
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