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FDA warns doctors about fentanyl buccal
Agent is used for pain management during cancer treatment but has been linked with deaths due to improper use.
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The FDA is alerting health care professionals to concerns regarding the use of fentanyl buccal tablets after recent reports of deaths and other adverse events.
Fentanyl buccal (Fentora, Cephalon), a potent opioid pain medication, is used only to treat breakthrough pain in patients with cancer who are receiving opioid treatment and have become tolerant to it.
The deaths reported resulted from improper selection of patients, dosing, or improper product substitution.
“The FDA is monitoring this issue very closely,” Steven Galson, MD, director of the Center for Drug Evaluation and Research, said in a press release. “We are working with the manufacturer to ensure the safest use of this medicine. Health care professionals and patients need to be aware of the potential for fatal overdose with improper use.”
In a recent Public Health Advisory and Health Care Professional Sheet, the FDA warned physicians and other health care professionals that it is critical to follow product labeling when administering fentanyl buccal.
The FDA further stated that it is dangerous to use fentanyl buccal for any short-term pain such as headaches or migraines.
It is critical that fentanyl buccal not be used in patients who are not opioid tolerant. Patients must be under a doctor’s care and close supervision while taking fentanyl buccal and the dose should be carefully adjusted to control breakthrough pain adequately.
The FDA is concerned about the improper substitution of fentanyl buccal for other pain medications. Fentanyl buccal is not the same as other fentanyl-based products and cannot be substituted for fentanyl citrate (Actiq, Cephalon), another fentanyl-based product used to treat cancer pain. Fentanyl buccal delivers more fentanyl to the blood than fentanyl citrate, and substituting fentanyl buccal for fentanyl citrate using the same dose can result in a fatal overdose.
On September 10, 2007, Cephalon sent letters to physicians and other health care providers advising them about the adverse events and deaths resulting from fentanyl buccal.
Cephalon and the FDA are collaborating to emphasize the appropriate patient selection, dosing and administration in the fentanyl buccal label and Risk Minimization Action Plan.
For more information:
- Adverse events related to this product should be reported to MedWatch, the FDA’s voluntary reporting program: www.fda.gov/medwatch.