The Risk Evaluation and Mitigation Strategy (REMS) targets extended-release (ER) and long-acting (LA) opioid drugs, including prescription medications containing oxycodone hydrochloride.
The investigation was sparked by a fatal oxycodone overdose in Middlesex, N.
"The abuse ratio for oxycodone combination products was 24 emergency department visits per million tablets dispensed, compared with 85 visits for oxycodone single-entity ER products, " the FDA reviewers said in the documents.
But the new observational study (Abuse Rates and Routes of Administration of Reformulated Extended-Release Oxycodone: Initial Findings From a Sentinel Surveillance Sample of Individuals Assessed for Substance Abuse Treatment), suggests a breakthrough.
If the panel's advice is adopted by FDA, it would put hydrocodone on par with prescription painkillers like oxycodone, morphine, and methadone -- drugs with high abuse potential that can lead to severe physical dependence.
From 2007 to 2010, prescriptions for oxycodone (the main ingredient in OxyContin) increased 82 percent in Nassau County, and the painkiller has contributed to more deaths than any other prescription opioid there since 2006, the report says.
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The FDA's warning letters notified the companies they may be subject to legal action if they do not stop manufacturing and distributing "prescription unapproved products" that include high-concentrate morphine sulfate oral solutions and immediate-release tablets containing morphine sulfate, hydromorphone or oxycodone.
The original OxyContin was, initially, seen as a breakthrough in pain relief because it would slowly release its active ingredient, oxycodone, over 12 hours, allowing people with chronic pain to be able to take fewer pills, sleep through the night, and generally be less tortured by their condition.
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