Fentora Safety Warning

The United States Food and Drug Administration has issued a safety warning for Fentora (fentanyl buccal tablets) to instruct people on how to safely use this pain medication. Fentora is a strong narcotic medication that can cause potentially dangerous and even life-threatening complications. For instance, it is important that this medication is only prescribed to people who are already taking an around-the-clock pain medication.

An Introduction to the Safety Warning for Fentora

Fentora^® (fentanyl buccal tablets) is a strong narcotic pain medication approved to treat breakthrough pain (intense increases in pain that "break through" the underlying around-the-clock pain medication) in people with cancer. It comes in the form of a tablet, which is dissolved between the upper cheek and gum.

The United States Food and Drug Administration (FDA) issued a warning to the public about the potential for serious side effects with Fentora use after receiving reports about deaths and other problems in people taking the medication. The deaths were a result of improper use of the medication.

Fentora Safety Information

The FDA warning highlights the following important safety information on Fentora:

Fentora is a potent narcotic opioid. It should only be used in people who are already taking regular, around-the-clock pain medication, as these people are more resistant to the dangerous side effects of the medication.

Fentora should not be used for any type of short-term pain, including pain from surgery or injury, headache pain, or migraine pain.

The dosage of fentanyl in Fentora is not equal to the same dosage of fentanyl in other fentanyl-containing products, including Actiq^® (fentanyl lozenges). Fentora should not be substituted for any other fentanyl medication, as doing so could cause a fatal overdose.

Healthcare providers should carefully select each person's individual Fentora dose, and carefully adjust doses to adequately control breakthrough pain.

Anyone who takes this medication should know how to use it safely and must follow the directions for use exactly. Fentora comes with a medication guide that describes the correct way to use this medicine. Make sure to read this guide each time you get your prescription filled, as new information may be available.