Fentanyl Patches Need Additional Safety Precautions, ISMP Recommends
This article was originally published in The Pink Sheet Daily
Executive Summary
J&J has submitted a risk management plan to FDA for its fentanyl patch Duragesic.
You may also be interested in...
Duragesic Public Health Advisory Follows Palladone Withdrawal
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.
J&J Duragesic “Black Box” Adds Fentanyl Abuse Warning
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.
NDAs Should Include More Cross-Study Analysis, FDA Says In Draft Guidance
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