Cephalon Issues Dear Doctor Letter for Fentora
Cephalon sent a set of Dear Doctor letters to healthcare providers last week to inform them of updated safety information pertaining to the cancer pain medication Fentora.
At least four people have died after being treated with the drug and others have experienced serious adverse effects attributed to misuse of Fentora (fentanyl buccal tablet).
The errors fell into two categories:
Tolerance: Fentora is intended to treat breakthrough pain in patients who are opioid-tolerant. The label defines that as patients who are already taking around-the-clock opioids. "That's the only way you can be sure they have acclimated to opoids and are not going to have any unexpected reactions," said Sheryl Williams, Cephalon's vice president of public affairs. "Someone might make a mistake and think that means a person who has taken an opioid in the past. That's not what it means."
Substitution: In addition, said Williams, some physicians with experience in prescribing fentanyl substituted Fentora. "There are differences in dosages and delivery," said Williams. The drug, formulated as a buccal tablet to be inserted between cheek and gum, is meant for rapid delivery of the dose.
The letter goes on to list dosing information and additional side effects. Fentora, an opioid agonist, is listed as a controlled substance and could lead to addiction, depression, and death if misused.
How Digital Medicine Can Pinpoint Dosing Regimens to Optimize Drug Efficacy and Safety