MONDAY, Jan. 10, 2011 (HealthDay News) -- Fentanyl (Abstral) tablets have been approved by the U.S. Food and Drug Administration to help opioid-tolerant adults with cancer manage so-called "breakthrough" pain that occurs suddenly and requires a short-term higher dose of a patient's round-the-clock opioid regimen.
Only doctors skilled in the use of Schedule II opioids should prescribe this product, the FDA said in a news release. Any pharmacy, distributor or health-care professional involved in Abstral's distribution or use will have to enroll in a Risk Evaluation and Mitigation Strategy (REMS) program, designed to minimize misuse and abuse, the agency added.
Abstral's safety was evaluated in clinical studies involving 311 opioid-tolerant cancer patients with breakthrough pain. The most common side effects included nausea, constipation, drowsiness and headache.
The FDA warned that the risk of death had been cited in studies of similar immediate-release fentanyl products. "The deaths occurred as a result of improper patient selection and/or improper dosing," the agency said.
Abstral is produced by ProStraken Inc., based in Bedminster, N.J.
To learn more about fentanyl, visit the U.S. National Institute on Drug Abuse.