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US FDA kicks 'moderate' out of ER/LA opioid pain indication, adds postmarket studies requirement

 
• By Donna Young

US regulators have ordered makers of extended-release (ER) and long-acting (LA) opioids, such as morphine, oxycodone and fentanyl, to add new warnings to the labeling of their products and revise the indications of the medicines as part of an effort to help curb the abuse and misuse of the drugs1,2.

US regulators have ordered makers of extended-release (ER) and long-acting (LA) opioids, such as morphine, oxycodone and fentanyl, to add new warnings to the labeling of their products and revise the indications of the medicines as part of an effort to help curb the abuse and misuse of the drugs1,2.

In addition, Food and Drug Administration commissioner Margaret Hamburg said she was invoking her authority to require ER/LA opioid manufacturers to conduct post-marketing studies of their products to evaluate long-term use – assessing risks of developing increased

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