Deaths Result from Improper Use of Pain Med Fentora

FDA Asks Cephalon, Inc. To Strengthen Warnings and Educate Medical Community

Fentanyl buccal tablets, marketed by Cephalon, Inc., as Fentora, is a potent opioid pain medication used to treat breakthrough pain in cancer patients who are receiving opioid treatment and have become tolerant to it. Some doctors have wrongly prescribed Fentora for patients with headaches and migraines.

The U.S. Food and Drug Administration (FDA) is warning health care professionals and consumers that deaths and adverse events, including severe breathing problems, have been reported from the:

Improper selection of patients who should use Fentora

Patients who take narcotic pain medications every day and around-the-clock develop tolerance, meaning that they are more resistant to the dangerous side effects of these medications than patients who take narcotic pain medication only when needed. Patients should only use Fentora if they are opioid tolerant. It is critical that Fentora is NOT used in patients who are NOT opioid tolerant. In addition, Fentora is NOT safe to use for short-term pain such as that caused by headaches, migraines, sports injuries, and pain from surgeries.

Improper dosing and use of Fentora for some patients

It is critical to be under a doctor's care when taking Fentora as a breakthrough pain medication since the potential for fatal overdose from improper use of Fentora is high. Do NOT share Fentora pain medication with others who are not prescribed to use it as a breakthrough pain medication. Fentora must not be used to treat pain from injuries, surgery, headaches or migraines. Health care professionals and patients using Fentora need to strictly follow the manufacturers guidelines for using Fentora. Patients should never chew or swallow the table. It should be placed in your mouth, against the gum, and be allowed to dissolve.

Improper product substitution for patients using Fentora