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Fentora Side Effects Can Be Fatal, Warns FDA

Public Health Advisory Cautions Against Off-Label Use of Fentora

Sep 26, 2007 | Parker Waichman Alonso LLP

Fentora, a powerful narcotic pain killer was the subject of a Food & Drug Administration (FDA) Public Health Advisory today.   The advisory was issued because the FDA has received reports of deaths and other serious side effects related to Fentora.   In the advisory, the FDA warns that Fentora should only be prescribed for approved conditions, and that dosage guidelines should be carefully followed.   Earlier this month, Fentora’s maker, Cephalon, Inc.,  sent letters to physicians containing many of the same warnings.

Fentora was approved only for treating pain in cancer patients.  It is intended for patients who experience breakthrough pain because they have developed tolerances to other opiate painkillers.   Fentora contains fentanyl, a highly addictive opiate that is 80 times more potent than morphine.   Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.   

While Fentora is only approved for cancer patients, it is known that many doctors prescribe the drug “off-label” for headaches and back pain.  Once a drug has been approved by the FDA  doctors are free to prescribe it as they see fit.  The FDA said that several Fentora-related deaths have occurred in patients who were prescribed the drug for off-label use.  The FDA advisory warns that Fentora should not be used for any other conditions including migraines, post operative pain or pain due to injury.   It should also only be given to patients who have developed opiate tolerance, as others will not be able to handle the high amounts of fentanyl contained in Fentora.

The FDA says that other Fentora deaths have been due to doctors prescribing higher-than-recommended doses of the drug.  The FDA advisory says that Fentora contains much higher amounts of fentanyl than other opiate painkillers, including Actiq.  For that reason, Fentora is not a suitable substitute for these other painkillers.  And the FDA says that doctors must use care in determining the appropriate dose of Fentora for each patient.

Finally, the Public Health Advisory warns people taking Fentora and their caregivers to carefully follow the drug’s label directions.  The agency also advises that patients and caregivers become familiar with the signs of fentanyl overdose.   These include breathing problems or shallow breathing; tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused.  Fentora patients exhibiting these symptoms should be given immediate medical attention.

At least three separate investigations are underway to determine if Cephalon is marketing Fentora for off-label use. Off-label marketing of a drug is illegal, even though off -label use is not. An investigation being conducted by the Connecticut Attorney General’s office has already determined that Cephalon actively promoted off-label use of Fentora’s predecessor, Actiq.   The US attorney in Philadelphia and a congressional probe are also looking into Cephalon’s marketing of Fentora.