Fentanyl Patches Need Additional Safety Precautions, ISMP Recommends
This article was originally published in The Pink Sheet Daily
J&J has submitted a risk management plan to FDA for its fentanyl patch Duragesic.
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FDA is investigating reports of deaths associated with overdoses of the fentanyl patch (J&J’s Duragesic and generics). As with Purdue’s opioid Palladone, alcohol consumption is cited as a possible factor in increased fentanyl release or effect.
Revised labeling also narrows the indicated population and warns about drug-drug interactions with CYP 3A4 inhibitors. FDA notes J&J is in “discussions with the agency regarding establishment of a risk management program.” Labeling changes were approved one week after Duragesic generics entered the market.
FDA is clarifying that it expects sponsors to provide analysis of efficacy data rather than simply a summary of clinical data as part of the integrated summary of effectiveness in new drug applications