Updated September 2007- Fentora (generic name fentanyl) is a pain management drug often used to treat breakthrough pain (BTP) in cancer patients. Fentora was approved by the U.S. Food and Drug Administration (FDA) on September 25, 2006, and was available for sale in the U.S. in October 2006. Since that time, a number of drug-related deaths have been reported among cancer patients who used Fentora.
Manufacturer Cephalon claims that Fentora is “the first and only buccal tablet developed and indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.” Fentora is classified as an
opioid agonist and Schedule II controlled substance, which is similar to morphine, hydromorphone, methadone, oxycodone and oxymorphone.
According to the manufacturer directions, the patient places the Fentora tablet between his or her upper cheek and gum above a rear molar tooth. As saliva mixes with the tablet, a chemical reaction occurs and releases carbon dioxide. About 48 percent of the Fentanyl is then absorbed directly into the bloodstream, and carried through the central nervous system to the brain and spinal cord to relieve pain. The patient then swallows the remainder of the tablet, which is more slowly absorbed into the gastrointestinal tract.
Serious Side Effects
Fentora has recently been associated with a number of adverse effects, which include death, severe respiratory depression, nausea, dizziness, vomiting, somnolence, headache, anemia, fatigue, constipation and dehydration.
Cephalon claims that the deaths were a result of improper dosing; however, reports say that serious or fatal respiratory depression may occur at recommended doses.
Life-threatening respiratory depression is the most serious side effect associated with this powerful painkiller. Fentora tablets can also be fatal to a child and should be kept out of reach of children at ALL TIMES.
Reported Fentora Deaths
On September 10, 2007, Cephalon sent letters to physicians in response to four reported
deaths that were linked to patient use of the powerful Fentora painkilling tablet. Some of the deaths due to
respiratory failure reportedly occurred in patients for whom doctors prescribed the drug to alleviate severe headaches.
It is believed that many of these physicians thought the Fentora lozenge to be a subsitute for Actiq, a narcotic painkiller lollipop. Fentora is actually much stronger than Actiq — while 65% of Fentora is absorbed in the blood stream, only 47% of Actiq is absorbed
In 2007, the Institute for Safe Medication Practices and the Division of Public Health Sciences, Wake Forest University School of Medicine, conducted a longitudinal Adverse Events Reporting System Review of the U.S. FDA's
most dangerous drugs. The study found fentanyl to be one of the most dangerous drugs on the market with the second highest number of suspect drug deaths. During the eight years of the study, fentanyl was one of the most lethal drugs in the study with over 3,500 deaths in an 8 year period.
See your doctor if you are experiencing problems related to Fentora or if you have experienced serious side effects associated with the drug. In addition, it may be important to
contact an attorney who can help you protect your legal rights. Please keep in mind that there may be
time limits within which you must commence suit.
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See Also
- Painkillers: Overview