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, 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.
4 Comments • Add Your Comments
Janet Rogers says:
I think it is important to phrase the prescribing instructions exactly as they are expressed in the pharmacist information found in the box insert. Unless a change has taken place, the information expressed that the Actiq is only approved for use in those with cancer pain AND those with breakthrough pain who can not manage their pain with other medications and who are already opioid tolerant, although as I recall, the word “and” is not used which made the sentence less clear. I was prescribed this medication by an anesthesiologist in a pain clinic and we read and discussed this phrasing and the distinction was pointed out to me. The two are not joined, as you have implied in your article by saying that it is for cancer patients who have breakthrough pain, etc. but rather it is for them and those with breakthrough pain, etc. ( without necessarily having cancer). The meaning is completely different when the message is paraphrased as you believe it’s intention stated rather than it’s literal one. I am sorry I no longer have those inserts to refer to but if you check them I think you will find the difference I am pointing out. If it is differently phrased now, it would be ~very~ interesting if this change reflects their original intention while the original phrasing was actually in error or poorly expressed to clarify this true intent. I know that when we read this literature it was open ended with respect to the breakthrough pain and in addition to the cancer patients, including those with other ailments. I think the text of these inserts are available at the web site of the drug manufacturer mentioned in the article, if anyone is interested in looking.
Posted on September 18, 2007 at 5:43 pm
Harvey Kirk says:
Ms. Rogers,
Thank you for your reply. It is not clear what document you reviewed with your doctors, but Actiq has only been approved for treatment of breakthrough pain in cancer patients. However, it has been common for those without cancer to receive the medication, as approximately 80% of the prescriptions written have been “off-label” to non-cancer patients.
The Actiq Medication Guide on the FDA website indicates:
Posted on September 22, 2007 at 11:22 pm
Jan says:
What is the fatal amount how is one to know they aren’t taking to much?
The reality and the concern my step brother was adminstered 100mcg
patch every 72 hrs then to 48 and 36. Then was upped the dosage
to 150 mcgrams w/ breakthrough Oxycontin? What is the amount of accidental overdosage? he is concerned w/ accidental overdose he accidentally doubled the dosage for missing one and was in a lot of distress it came to 300 mcgs is that a fatal amount or what is?
Posted on March 17, 2009 at 12:57 am
nickolas says:
came home found my son dead on the bathroom floor 6 pm odtopsy said he died 7 am of fetenayl over dose
Posted on August 16, 2022 at 4:13 pm