Comments on: Fentanyl overdose deaths linked to off-label use of Fentora http://www.youhavealawyer.com/blog/2007/09/14/fentora-death-overdose-warning/ Saiontz, Kirk & Miles personal injury and medical malpractice lawyers. Mon, 8 Sep 2008 14:15:41 +0000 http://wordpress.org/?v=2.5.1 By: Harvey Kirk http://www.youhavealawyer.com/blog/2007/09/14/fentora-death-overdose-warning/#comment-20041 Harvey Kirk Sun, 23 Sep 2007 03:22:29 +0000 http://www.youhavealawyer.com/blog/2007/09/14/fentora-death-overdose-warning/#comment-20041 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 <a href="http://www.fda.gov/cder/Offices/ODS/MG/fentanyl_citrateMG.pdf" rel="nofollow">Actiq Medication Guide on the FDA website </a>indicates: <blockquote>Actiq is to be used only to treat breakthrough pain in adult patients with cancer (16 years of age and older) who are already taking other opioid pain medicines for their constant (around-theclock) cancer pain. Actiq is started only after you have been taking other opioid pain medicines and your body has gotten used to them (you are opioid tolerant). Do not use Actiq if you are not opioid tolerant.</blockquote> 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:

Actiq is to be used only to treat breakthrough pain in adult patients with cancer (16 years of age and older) who are already taking other opioid pain medicines for their constant (around-theclock) cancer pain. Actiq is started only after you have been taking other opioid pain medicines and your body has gotten used to them (you are opioid tolerant). Do not use Actiq if you are not opioid
tolerant.

]]> By: Janet Rogers http://www.youhavealawyer.com/blog/2007/09/14/fentora-death-overdose-warning/#comment-19846 Janet Rogers Tue, 18 Sep 2007 21:43:45 +0000 http://www.youhavealawyer.com/blog/2007/09/14/fentora-death-overdose-warning/#comment-19846 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. 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.

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