Following its product safety alert earlier this month, the US Food and Drug Administration has now issued a public health advisory alerting health care professionals and consumers to reports of adverse events, including deaths, in patients taking Cephalon’s Fentora (fentanyl buccal), the potent pain medication for treatment of breakthrough pain in cancer patients who have become tolerant to opioid treatment.
The deaths “were the result of improper selection of patients, dosing, or improper product substitution”, the Agency notes. “FDA is monitoring this issue very closely,” said Steven Galson, Director of the FDA’s Center for Drug Evaluation and Research. “We are working with the manufacturers to ensure the safest use of this medicine. Healthcare professionals and patients need to be aware of the potential for fatal overdose with the improper use of Fentora.”
It is dangerous to use Fentora for any short-term pain such as headaches or migraines, the FDA warns in its Public Health Advisory and Health Care Professional Sheet, adding that it “is critical that Fentora is not used in patients who are not opioid tolerant”. It further warns that improper substitution of fast-acting Fentora for other pain medicines can result in a fatal overdose, pointing out that Fentora is not the same as other fentanyl products and cannot be substituted for Cephalon’s Actiq (fentanyl citrate), since it delivers a higher dose of fentanyl to the blood than Actiq.
The FDA has asked Cephalon to strengthen warnings and improve the dosing instructions in the drug’s product labelling, as well as improve its education plan for prescribers and pharmacists on the proper patient selection, dosing instructions and restrictions on substituting Fentora for other products.