MONDAY, Jan. 10 (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
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,
To learn more about fentanyl, visit the U.S.
National Institute on Drug Abuse.