Fentanyl belongs to a class of drugs called opioids. Fentanyl is an extremely potent opiod—80 to 100 times stronger than morphine. Fentanyl can be prescribed outside the hospital in pill, lollypop and patch form. Unfortunately, all three versions are being inappropriately prescribed and are killing hundreds of people.
A fentanyl patch consists of a backing, fentanyl laced adhesive and a release liner. The release liner is removed and the patch is placed on the body, usually on the arm, shoulder or back. Patches come in sizes of 12, 25, 50, 75 and 100 mcg/hr. The main brands of fentanyl patches are Duragesic, Sandoz, Mylan, Actavis and Watson.
The patch is designed to release fentanyl for 3 days and then to be replaced with another patch. Fentanyl patches are approved only for chronic (i.e., long lasting) moderate to severe pain that has not responded to other less potent pain medications. Fentanyl patches are not to be used for acute or postoperative pain.
A “black box warning” set out in the prescribing information insert that accompanies the fentanyl patch includes the following warning to health care professionals:
Respiratory Depression and Death
Respiratory depression and death may occur with use of DURAGESIC, even when DURAGESIC has been used as recommended and not misused or abused.
DURAGESIC is contraindicated for […] acute pain, and postoperative pain.
A “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.
Elsewhere, the prescribing information insert repeats such warnings:
DURAGESIC is contraindicated in the following patients and situations due to the risk of fatal respiratory depression: […]
- in the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of time.
Respiratory Depression and Death
Respiratory depression is the chief hazard of DURAGESIC. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.
DURAGESIC has a narrow indication and should be prescribed only by healthcare professionals who are knowledgeable in the administration of potent opioids and management of chronic pain […].
DURAGESIC is contraindicated for […] acute pain, and postoperative pain
Despite all of these warnings, the ignorance of doctors when it comes to fentanyl is shocking. One of the mistakes that our firm continues to see doctors commit in prescribing fentanyl patches that causes deaths is prescribing the patch for acute or postoperative pain.
Here is what the FDA has to say in its 2009 Public Health Advisory about the problem:
Despite issuing an advisory in July 2005 that emphasized the safe use of the fentanyl patch, FDA continues to receive reports of death and life-threatening side effects in patients who use the fentanyl patch. The reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should not be prescribed.
Unfortunately, we are still seeing cases of doctors prescribing the fentanyl patch when it should not be prescribed. Our firm has represented the families of patients killed by this very error—from patches prescribed after surgery for reflux to patches prescribed after a broken arm and patches prescribed after a hysterectomy. The fact that fentanyl patches should not be prescribed for post operative pain is so important that a warning is about this contraindication is even printed on the box in which the patches come.
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.
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.