FDA Taking Hard Look at Fentanyl Dosage Forms
Conlan, Michael F., Drug Topics
Real and potential misuses of fentanyl are drawing increased federal scrutiny to two dosage forms of the powerful opioid. On Jan. 18, the Food & Drug Administration announced that Janssen Pharmaceutical was revising the labeling for Duragesic, its fentanyl transdermal patch, and adding a boxed warning against its use to manage acute or postoperative pain. The FDA expressed concern that misuse of the patch could result in serious or life-threatening breathing problems and said that several deaths have occurred.
A week later, the FDA was asked by the Public Citizen Health Research Group and several physicians to reverse its approval of Oralet, a fentanyl citrate lollipop-style lozenge mounted on a plastic handle. Developed by Anesta Corp. and licensed to Abbott Laboratories, its primary use would be as a premedication for children about to receive general anesthesia. Sidney Wolfe, the HRG's executive director, said that Oralet's potential benefit of calming children before surgery was far outweighed by the risks of misuse and resultant respiratory depression.
In addressing Duragesic, developed by Alza Corp., FDA commissioner David A. Kessler linked inappropriate prescribing to four patient deaths. "We are taking steps to protect future patients by making sure the drug is prescribed safely," Kessler said. The patch was approved in 1990. In a letter to 500,000 health-care professionals outlining the labeling changes, Janssen said the drug had a good safety and efficacy record "when used carefully in accordance with the labeled instructions for use."
In addition to not using Duragesic to manage acute or postoperative pain, including pain after outpatient surgery, it is not to be:
* Used for mild or intermittent chronic pain that can be managed with less powerful drugs. …