November: Actiq (fentanyl) approved first pain medicine approved to treat cancer breakthrough pain but with additional safety concerns. There was no evidence to suggest at the time that crushing the controlled-release capsule followed by oral ingestion or snorting would become widespread and lead to a high level of abuse. Also at the time of Ox圜ontin’s approval, FDA product labeling warned of the danger of abuse of the drug and that crushing a controlled-release tablet followed by intravenous injection could result in a lethal overdose.In part, FDA based its judgment on the prior marketing history of a similar product, MS Contin, a controlled-release formulation of morphine approved by FDA and used in the medical community since 1987 without significant reports of abuse and misuse. At the time of approval, FDA believed the controlled-release formulation of Ox圜ontin would result in less abuse potential, since the drug would be absorbed slowly and there would not be an immediate “rush” or high that would promote abuse.Ox圜ontin would soon become a focal point of opioid abuse issues that would continue to escalate into the late 2000s and beyond.
US TIMELIME PATCH
May: MS Contin, (morphine sulfate) approved first formulation of an opioid pain medicine that allowed dosing every 12 hours instead of every 4 to 6 hours.Īugust: Duragesic (fentanyl transdermal system) approved first formulation of an opioid pain medicine in a patch (sometimes referred to as a “skin patch”) that is changed every 3 days.ĭecember: Ox圜ontin (oxycodone controlled-release) approved first formulation of oxycodone that allowed dosing every 12 hours instead of every 4 to 6 hours. Studies showing inadequate treatment of chronic non-cancer pain by physicians lead to an increased use of opioids. Opioid pain medications were used primarily for acute pain and cancer pain.
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