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Opioid REMS Increases Nearly Six-Fold As US FDA Adds Immediate-Release Products

 
• By Michael Cipriano

Basically every doctor prescribing any opioid is now covered by the REMS, but training remains voluntary. 

Opioid abuse epidemic concept

The number of opioids encapsulated by the US FDA's risk evaluation and mitigation strategy (REMS) has now increased nearly six-fold, as the agency officially extended it to immediate-release (IR) opioids intended for use in an outpatient setting.

When first created in 2012, the REMS only applied to 62 extended-release (ER) and long-acting (LA) products, but the extension to IR opioids announced Sept. 18 has now bloated that number to 347

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