Proper Use of Fentanyl Pain Patches
Meadows, Michelle, FDA Consumer
Fentanyl skin patches provide convenient and effective relief for many people who experience chronic pain, and who have been taking pain medications for long periods of time. But health care providers and patients should be aware that deaths and other serious problems have resulted from accidental overdoses related to inappropriate use of the fentanyl patch, the Food and Drug Administration says.
The patch is applied to the skin and delivers fentanyl, a potent, strong opiate analgesic. The drug is slowly absorbed through the skin into the bloodstream and can relieve pain for up to three days from a single patch application.
"After applying the first patch, it can take 12 to 18 hours to reach the peak of pain relief, with some early pain relief occurring at four to six hours after the first administration," says Donald R. Stanski, M.D., a professor of anesthesia at Stanford University who was involved with the clinical drug development of the first fentanyl patch in the 1980s.
The most frequent use of the fentanyl patch has been to treat pain in people with cancer, and it is only appropriate for patients who have developed a degree of tolerance to the opiate analgesic effects because they have been previously using this type of drug, says Robert J. Meyer, M.D., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.
"Because the patch provides slow, continuous drug delivery, people with constant pain are less likely to experience waxing and waning of pain control," as occurs when the traditional oral medication or injections of the opiate wear off, Meyer says. Some people can experience breakthrough pain, which may require additional analgesic medication. "With the patch, patients don't have to take multiple doses of oral medications to control the underlying chronic pain," Meyer says. "But in some reports of overdose, we have seen misunderstandings about the recommended use of the product." Proper use of the patch that follows the drug's label is crucial.
The FDA is investigating deaths and overdoses that have occurred with both brand-name and generic fentanyl patches. The brand Duragesic (fentanyl transdermal system), manufactured by Janssen L.P. of Titusville, N.J., was approved by the FDA in 1990. A generic version, manufactured by Mylan Laboratories Inc. of Canonsburg, Pa., was approved in 2005.
In July 2005, the FDA issued a public health advisory on the fentanyl patch. Meyer says the advisory focuses on improving education about the signs of an overdose, proper patch application, drug interactions, proper storage and disposal of the patch, and safeguards for children.
The powerful pain-relieving properties of all opiates are countered by significant risks of depressed breathing that can cause unexpected death. Signs of an overdose include trouble breathing or shallow breathing, extreme sleepiness or sedation, an inability to walk or talk normally, and feeling faint, dizzy, and confused. People who experience these symptoms should seek emergency medical attention. Removing the patch won't reverse the problem; the drug is still absorbed into the body for more than 17 hours after the patch is removed.
The fentanyl patch should not be used for short-term, acute pain, pain that is not constant, or pain after an operation. "The patch is not for pain that occurs after surgery such as tonsillectomies or dental procedures," Meyer says.
The patch is only for people who experience moderate-to-severe chronic pain that is expected to last for weeks or longer and that cannot be managed by acetaminophen-opioid combinations, nonsteroidal analgesics, or as-needed dosing with short-acting opioids.
The patch also shouldn't be the first narcotic pain medicine that is prescribed. It should be used only in people who have been taking opiate analgesics for a period of time. …