FDA Issues Warning on Cancer Drug Fentora

The Food and Drug Administration has issued a warning concerning the use of Fentora (fentanyl buccal) tablets. There have been reports of adverse effects and even deaths.

Fentora is a powerful opioid pain medication that is only used in the treatment of breakthrough pain, which is very intense increases in the level of pain that happens even when the patient is receiving opioid pain control medication. It is only used in patients who are receiving opioid treatment who also have become tolerant to treatment.

When it becomes necessary for the patient to take narcotic pain drugs around the clock, they eventually develop a tolerance to them and also become more resistant to the dangerous side effects than those who take the medications less frequently.

The deaths that were reported resulted from giving the medications to the wrong type of patients, improper dosing, or improperly substituting one product for another.

In the advisory the FDA warns that it is absolutely imperative the instructions on the label be followed exactly and to the letter. They also say that there is danger in giving Fentora for any type of short term pain, such as that in a migraine. And Fentora is only to be used in patients who are tolerant to opoids.

Patients are also required to be closely supervised by a doctor and the dose must be carefully monitored and if necessary, adjusted so that the pain is properly controlled.

The FDA is also concerned that Fentora is being is being substituted for other pain medications because it is fast acting. It is not the same as products in the fentanyl family of drugs and it cannot be substituted for any of them such as Actiq, which is also used for the relief of breakthrough pain because Fentora is more powerful and it delivers more fentanyl to the blood than Actiq does, so if it is substituted Actiq in the same dose, the result can be a fatal overdose.