The warning to doctors is set out in a “black box” for emphasis and printed in boldface type: “DURAGESIC should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to DURAGESIC 25 mcg/h.”
A so-called “black box warning” means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. It is the strongest alert the FDA can require. However, doctors and other prescribing health care professionals still just don’t understand: fentanyl patches can kill when prescribed for patients who are not already tolerating relatively high doses of similar opioid painkillers.
No fentanyl patch of any dosage should be prescribed to a patient who is not “opioid tolerant.” The term “opioid naive” refers to patients who are not already receiving opioids on a daily basis. “Opioid tolerant” refers to patients who are receiving opioids on a daily basis. In this context, the package insert warnings explain to health care providers that “[p]atients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.” A patient must meet this definition of opioid tolerance before being prescribed even the lowest dose of fentanyl patches. The definition of “opioid tolerant” might sound confusing or complicated to you, but it’s actually quite clear to doctors—that is, it is clear to doctors who bother to familiarize themselves with this important warning.
For years, a significant part of our law firm’s practice has involved representing the survivors of people who died wearing fentanyl patches. We have learned that patients continue to be prescribed fentanyl patches even though the patients are clearly not sufficiently “opioid tolerant.” For example, a new study about the prescription of painkillers such as oxycodone and hydromorphone found that, out of a review of 11,184 patients with new use of transdermal fentanyl, 80.7% of those had received no other high-potency opioid before and 52.9% had received neither low-potency nor high-potency opioids before!
Heygood, Orr & Pearson fighting for patient safety
The lawyers at Heygood, Orr & Pearson are among the nation’s leaders in handling cases involving potent opioids, and our law firm has the experience to prosecute medical malpractice cases involving a wide array of serious opioid painkillers, including Vicodin and Hydrocodone, OxyContin and Oxycodone, Methadone, Hydromorphone, Fentanyl, and others.
With respect to fentanyl, Heygood, Orr & Pearson has successfully prosecuted more cases involving deaths due to fentanyl products than all the other firms in the country combined. We have spent years studying fentanyl, its uses and its misuses. We have deposed hundreds of doctors, scientists and experts on the subject of fentanyl products.
Transdermal fentanyl patches should be used ONLY in patients who are already receiving opioid therapy and who have demonstrated tolerance and who are not opioid naive. Giving potent, long-acting opioids like a fentanyl patch to opioid naïve patient has resulted in deaths.
If you or a loved one has experienced the tragedy of losing a family member as a result of Fentanyl pain patch usage, you and your family deserve answers to your questions. If the loss was as a result of a prescribing error, you have the right to demand that the responsible healthcare provider be held accountable. Contact us for a free consultation so we can help you determine the best way to protect your legal rights and interests.
To receive a free legal consultation and find out if you are eligible to file a case, please call our toll-free number at 1-877-446-9001, or by filling out our free case evaluation form located on this page.