The US Food and Drug Administration (FDA) has issued a warning, alerting health professionals and patients about the potential misuse and side effects of Fentora (fentanyl buccal), a tablet-based drug that is approved only for the treatment of breakthrough pain in people with cancer.
There have been recent reports of deaths and adverse side effects in connection with the drug, which is made by drug company Cephalon Inc.
This follows the news earlier this month that the company sent letters to doctors and other health professionals about the reported adverse events and deaths.
The agency has asked the company to strengthen product warnings, make the dosing instructions clearer, and improve educational programmes and materials so that prescribers and pharmacists are better informed about patient selection, dosing and restrictions, particularly on substituting Fentora for other drugs.
Fentora is a powerful opioid and is only used for cancer patients who have become tolerant to opioids during treatment for breakthrough pain.
Breakthrough pain is an intense increase in pain that can come on suddenly and occurs even when opioid pain control is already being administered.
Patients who are on narcotic pain drugs 24/7 become tolerant and resistant to the dangerous side effects compared to patients on a less intense and frequent dose.
According to the FDA, who are continuing to investigate the events, the fatal events linked to Fentora use were the results of improper patient selection or substitution of the drug. Dr Steven Galson, director of the FDA’s Center for Drug Evaluation and Research said in a statement that the FDA was monitoring this very closely and:
“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 the improper use of Fentora,” cautioned Galson.
The FDA has issued a Public Health Advisory and Health Care Professional Sheet, in which the agency warns physicians and other health care professionals of the critical importance of observing the product label information when administering Fentora.
The agency warned it is dangerous to use Fentora for any pain of a short term nature such as headaches or migraines. And, it is critical that patients who are not opioid tolerant, do not receive Fentora.
Administration of Fentora should be accompanied by supervision and continuous monitoring under a doctor, so that the dose is carefully adjusted for controlling the breakthrough pain for a particular patient.
The FDA is also concerned about improper substitution of Fentora for other medications.
It is not the same as other fentanyl drugs said the agency, and cannot replace for example the drug Actiq, another fentanyl product that is also used for breakthrough cancer pain. This is because Fentora has a stronger effect, it delivers more fentanyl to the blood than Actiq, and so giving it instead of Actiq (for instance using the same dose) could lead to a fatal overdose.
The FDA has a voluntary programme for reporting adverse events related to approved drugs, called MedWatch.