Fentanyl overdose deaths linked to off-label use of Fentora
According to warnings posted yesterday by the FDA, Fentora has been linked to several deaths caused by fentanyl overdose. Fentora is a newer medication, similar to the Actiq lollipop, which is only approved for use in cancer patients who have breakthrough pain not managed by other medications. The manufacturer of Actiq and Fentora, Cephalon, Inc., is currently being investigated for improper marketing practices which encouraged widespread off-label use of their powerful drugs for conditions such as headaches and back pain.
>>INFORMATION: Fentanyl death and overdose
Fentora contains fentanyl, a highly addictive substances which is classified in the same category by the DEA as cocaine. It has a high potential for abuse and carries a significant risk of a fatal overdose. Unlike the Actiq Lollipop, which delivers the fentanyl through a lozenge on the end of a stick, Fentora is a more discrete version in tablet form made by the same company.
The FDA approved Fentora tablets last year, in September 2006 and nearly 80,000 prescriptions have been written. It is only approved for the extremely limited purpose of treating breakthrough pain in cancer patients who can not manage their pain with other medications and who are already opioid tolerant. The older and less powerful version, Actiq, was also only approved for this limited purpose, but the Wall Street Journal reports that 17 months of prescription data show that over 80% of the individuals who used Actiq did not have cancer.
Several Fentora deaths have been reported after the opioid was used by individuals suffering from less severe ailments, such as headaches. A “Dear Doctor Letter” posted on the FDA Med Watch website yesterday cautions that Fentora should only be used for its intended purpose in cancer patients who are already tolerant of opiod therapy for their underlying cancer pain. If the fentanyl tablets are used off-label, it could increase the risk of Fentora overdose, respiratory depression or death.
The manufacturer of Fentora and Actiq, Cephalon, Inc., is currently facing criminal investigations regarding their marketing practices by the U.S. attorney in Philadelphia and the attorney general in Connecticut. They are also part of a congressional probe into off-label promotion of prescription medications.
As part of their investigation, the Connecticut attorney general found that Cephalon aggressively promoted Actiq lollipops for off-label uses which have not been approved by the FDA. This has contributed to hundreds of fentanyl deaths associated with the use of Actiq. The company set unrealistic sales quotas for their drug representatives and encouraged them to push larger prescriptions at higher doses to increase profits. They have also marketed the drug to many doctors who do not treat cancer patients.
FENTANYL DEATH LAWSUITS
The Fentanyl lawyers at Saiontz, Kirk & Miles, P.A. are currently investigating potential claims for death associated with the Actiq fentanyl lollipop, as well as a different form of fentanyl delivered through a patch, known as the Duragesic patch. Potential Fentora lawsuits are also now being reviewed for those who received the medication for non-cancer pain and subsequently died from a fentanyl overdose.
Fentanyl lawsuits are being investigated throughout the United States. If a friend or family member suffered a fentanyl death after using Fentora, Actiq or Duragesic Patch, request a free legal consultation to determine if you there may be a basis for a lawsuit.
