Fentanyl

FENTANYL PAIN PATCH CAN CAUSE DEATH FROM PATCH DEFECTS

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For patients who suffer from the unrelenting misery of what is called “breakthrough pain,” the development of a patch to deliver pain-killing drugs appeared to be a god-send. Paired with fentanyl, a powerful opiate-based analgesic 60 to 80 times stronger than morphine, the patch promised consistent relief for persistent pain that cannot be alleviated with conventional medications.

Fentanyl is one of a family of opiate-based drugs that, when used properly, provide effective pain management for patients with severe, ongoing pain that cannot be managed with more traditional pain killers. Cancer patients, for example, often experience breakthrough pain while undergoing treatments for their disease.

The problem with using these very strong painkillers is the danger of overdose, which can occur when the drug is administered too quickly, in excessive dosages, through direct exposure because of a manufacturing defect, or to patients who are sensitive to opiate-based drugs. Symptoms of overdose can include:

Slow breathing
Seizures
Tiredness
Confusion
Cold and clammy skin
Decreased pupil size
Dizziness or weakness
Loss of consciousness or coma

The fentanyl transdermal patch is supposed to avoid overdose by delivering the painkiller over an extended period of time. But that’s not always the case.

The pain patch commonly used to deliver fentanyl to victims of severe, unrelenting pain works by introducing the pain medication through fat cells, so that the drug is distributed to the patient’s body over an extended period of time of about 72 hours.

As early as 1995, however, dangerous problems surfaced. The Food and Drug Administration began taking action in connection with the transdermal patches, issuing recalls and demands for labeling changes. Among the potentially-lethal dangers of the fentanyl transdermal patches are that overdoses can occur when patches are cut, damaged, or defective. The fentanyl transdermal patches have been linked to respiratory depression, respiratory arrest, and even death. In 2004, the FDA warned fentanyl pain patch users of the high danger of overdose because of leakage, and initiated the first of what would soon prove be multiple recalls of patches made by Johnson & Johnson subsidiaries. In 2005, the FDA stated in a Public Health Advisory that it had received 120 reports of deaths related to fentanyl patches.

Most recently, in December 2008, PriCara - a division of Ortho-McNeil-Janssen under the umbrella of parent company Johnson & Johnson - recalled some lots of defective Duragesic and Sandoz Inc. fentanyl transdermal system patches. PriCara blamed a manufacturing equipment defect that, in some patches, resulted in a slit along one side of the drug reservoir. This created the possibility of fentanyl gel leaking out into the packaging, exposing patients or caregivers directly to the gel and, therefore, to serious overdose consequences - including death.

In addition to the risk of defective patches, health professionals are concerned about the potential for accidental overdoses of fentanyl, which can occur:

In patients sensitive to opiate-based drugs;
In patients who handle the patch and come in contact with the drug delivery side of the patch; and
When patients accidentally damage the patch.

In February 2009, the FDA sent letters to manufacturers of the fentanyl patch, requiring them to develop a Risk Evaluation and Mitigation Strategy (REMS) to demonstrate that the drug’s benefits outweigh the potential risks. These patches are manufactured in generic form or name brand by companies that include Johnson & Johnson, Ortho-McNeil, Janssen, Novartis, Mylan Technologies, and Actavis.

The FDA’s notification letter specifically named drugs containing the active ingredients fentanyl, hydromorphine, methadone, morphine, oxycodone, and oxymorphine. The letter explains that while these drugs can be beneficial when used properly, there are serious risks when they are used improperly. According to the FDA, the rates of misuse and abuse, and of accidental overdose, have increased in the past decade. The agency hopes that risks can be reduced through the required strategies, so that patients with legitimate needs can continue to have access to the drugs.

We would have expected between 1995 and 2007 that the manufacturers of these patches would have developed and highly publicized safety guidelines, but they didn’t. Instead, the FDA had to issue an updated Advisory in 2007 urging health professionals, patients, and caregivers to follow these guidelines:

Fentanyl skin patches are very strong narcotic (opoid) painkillers that may cause death from overdose. The fentanyl skin patch always should be prescribed at the lowest dosage needed for pain relief.
Fentanyl skin patches should not be used to treat short-term pain, pain that is not constant, or for pain after an operation. Fentanyl skin patches should be used only by patients who are already taking other narcotic painkillers and so are opoid tolerant. The patches should not be used by those who have chronic pain that is not well-controlled with shorter-acting painkillers.
Patients who are using the fentanyl skin patch, and their caregivers, should be informed about how to use the patch safely, and should follow the directions exactly. Makers of the fentanyl transdermal patches provide patient package inserts with directions, as is required by FDA regulations.
Patients and their caregivers must be told how to store fentanyl transdermal patches and dispose of unused or defective patches. Patches should be stored out of the reach of children, and disposed of by folding the sticky side together and flushing the patch down the toilet.
Health care professionals who prescribe the fentanyl transdermal patch, their patients, and patient caregivers should be aware of the signs of fentanyl overdose. Patients and caregivers must know what symptoms to look for, and understand that if any of the signs occur, they should get medical attention immediately.
The effect of fentanyl is more potent, and can increase suddenly, in the presence of alcohol or other medicines that affect brain function. Patients should pay careful attention to the product label, which warns of the dangers of drinking, taking drugs that have an impact on brain functions or how the body breaks down fentanyl, or being exposed to heat or an increase in body temperature.

If a family member has died from an overdose caused by a fentanyl transdermal patch, or you or a family member has been seriously harmed by the patch, the attorneys at Searcy Denney can help you learn about your rights.

Our law firm has substantial experience handling cases involving defective medical devices, unsafe pharmaceuticals, and medically-related deaths and injuries. We have teams of attorneys, paralegals, investigators, and medical experts who can help you evaluate your fentanyl transdermal patch claim and determine your right to seek justice. Please fill out our Contact Form , or call us for a confidential free consultation.

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Fentanyl

FENTANYL PAIN PATCH CAN CAUSE DEATH FROM PATCH DEFECTS

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