Men become accustomed to poison by degrees.
-Victor Hugo
"Cephalon says improper use of pain medication caused deaths in cancer patients"
FENTORA (fentanyl buccal tablet) is a potent opioid analgesic, intended for buccal mucosal administration. FENTORA is formulated as a flat-faced, round, beveled-edge white tablet.
FENTORA is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa.
FENTORA employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa.
One can't be too careful when prescribing narcotics for the relief of pain, but in my job I frequently have to be aggressive with narcotics in order to help patients suffering from the severe effects of tumors in the liver, skeleton or soft tissues. I start out prescribing a lower dose of medicine then increase the it until the pain is relieved or unacceptable side effects appear.
In 18 years of practice I have never seen a death from an overdose of narcotics. This is the difference between taking narcotics for cancer-related pain compared to a headache. Patients with cancer build up a tolerance to painkillers, which is a grisly tribute to the effectiveness of a tumor's ability to torture.
Cephalon spokeswoman Candace Steele said the company has received reports of three deaths related to inappropriate prescribing of the drug. The deaths occurred during the summer and are most likely due to respiratory failure, she said. Two deaths were in patients who could not tolerate narcotics and were prescribed Fentora for headache or migraine. One death was associated with improper dosing, Steele said.
Good heavens - why on earth would a doctor prescribe a fast-release potent narcotic like fentanyl for a migraine? As far as incorrectly switching a patient from Actiq to Fentora, the product information sheet has a clearly written chart showing the lower doses of Fentora to use when making the switch.
All doctors take the responsibility of prescribing narcotics with gravity and probity (I hope). Having said this, I realize that it is impossible to predict the individual reaction to any pain medicine, but to those docs who like to use Fentora (78,000 total prescriptions written in one year according the the Wall Street Journal), I have a confession to make.
This is the first I have ever heard of this product, Fentora. Does this mean I don't read the advertisements in medical journals? Does this mean I have banned most if not all pharmaceutical reps from my office? Does this mean one can practice the art and science of medical oncology without having to use every costly new supportive-care medicine that comes along, especially one that requires the utmost caution to avoid causing a fatal reaction?
Yes, yes and yes.
Absence and death are the same - only that in death there is no suffering.
-Walter Savage Landor
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I wonder if there will be/were any accidental overdose with Fentora since it's in a pill form... people might ingest it like a typical oral drug. Thought it might be too big and fizzy to swallow. At least with Actiq the stick is there to remind people to dose slowly.
78,000 perscriptions and 3 deaths. Sounds like they have a pretty good record. I wonder if the FDA will investigate to see if it should be pulled from the shelves.
Hear! Hear!
As I was reading this post, I was actually feeling stupid, never having heard of Fentora either. And certainly, that's not from an unfamiliarity with narcotics. I sometimes worry about the ease with which I write opioid prescriptions, but (just like you) I realize that these drugs are the only way to effectively control the pain and agony cancer causes my little patients. Just like you, I have never seen a death from an unintentional narcotic overdose in my patients. Now, if only there was a way to ensure that none of my teenaged patients became addicted.
With regard to Fentora, there is a substantial market in the Pain Franchise (as the pharmaceutical-marketing pholks call it) for this product, in particular for non-cancer breakthrough pain.
Let me remind all that there exists a rather significant population of pain patients who are opioid-tolerant. This doesn't just mean people with lower back pain of unclear etiology, but migraineurs, folks with neuropathic pain (now of course better initially Rx with topirimate, pregablin, and the like) of all types (diabetic neuropathy is more common than one might think as is post-HSV pain). If you have any doubts take a look at the papers of Russ Portnoy and his colleagues on Medline.(BTW he is a consultant for Cephalon as well as every other pain pharma company but is as unbiased as anyone else IMHO)
My understanding of the situation is that an inappropriate dose was administered because of BOTH physician and pharmacist error. ANY potent opioid administered in an outpatient setting I think possesses this hazard and in my view Fentora is useful in these populations.
One can question the "added value" of Fentora as a pharmacoeconomic issue vs. other available preparations. They also come with problems. All I can say is that the trend in Pharma today is to take existing analgesics and to tweak them with novel pharmaceutics to get different, improved pK/ADME. I think Fentora does fill a legitimate need in this regard.
I would prefer that Pharma develop NCEs (new chemical entities) with better pharmaceutic properties which might present advantages from the respiratory depression standpoint. Such compounds exist but I only know of one company (Adolor) which is going this route and they are having a tough time of it and are looking at falling back on other approaches.
Unfortunately this probably isn't going to happen because the cost and risk of going with an NCE precludes most people except Big Pharma taking that risk. You would be amazed to know how much grief the FDA has given people even over development of Fentanyl; they want to treat it like a totally new drug because it was introduced prior to the present standard of pharmaceutical development and has never been subjected to the usual battery of preclinical pharm-tox test now standard.
FENTORA (fentanyl buccal tablet) is a potent opioid analgesic, intended for buccal mucosal administration. FENTORA is formulated as a flat-faced, round, beveled-edge white tablet. FENTORA is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of fentanyl across the oral mucosa. FENTORA employs the OraVescent® drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of fentanyl through the buccal mucosa.