New Deaths Spur Renewed FDA Fentanyl Patch Warning

By Peggy Peck
ROCKVILLE, Md., Dec. 21 -- Two years after the FDA warned that fentanyl transdermal devices were linked to 120 deaths, patients are still dying because physicians still misprescribe the patches and patients still misuse them, the agency warned today.
But the FDA said it couldn't give an exact death total, citing the vacation absence of staffers in the know. Rob Rappaport, M.D., director of the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products, expected hard numbers in a week or so.
But he stressed at a news conference that the absolute number was "not that large and the important issue is not how large a number, but rather that the product is still not being used correctly."
Fentanyl patches, he said, should only be used in patients who are opioid tolerant. Using it in patients who have not yet developed opioid tolerance was likely to cause serious respiratory depression.
Moreover, the patches should only be used in patients with severe, chronic pain. The patch should not, he said, be used to treat headache pain, which was the case with at least one adverse event case reported to the FDA.
"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," the FDA said.
"In addition, the reports indicate that patients are continuing to incorrectly use the fentanyl patch by replacing the patch more frequently than directed in the fentanyl patch instructions, applying more patches than prescribed, or applying a heat source to the patch."
In the two years since the first fentanyl warning, some groups have urged the FDA to limit physicians permitted to prescribe fentanyl -- reserving this, for instance, to pain medicine specialists.
Dr. Rappaport said that approach would unnecessarily limit patients' access to an effective analgesic. He said an estimated 60 million Americans suffer chronic pain syndromes, "but there are only about 4,000 pain medicine specialists."
In addition to this second safety warning, the FDA said it has ordered manufacturers of fentanyl patches to create medication guides for patients that describe in detail the dangers of fentanyl overdoses and simple directions about proper use.
The guides will, for example, warn patients not to expose the patch to heat with heating pads, heated waterbeds, or hot tubs. Heat exposure, Dr. Rappaport said, speeds release of fentanyl into the bloodstream.
Patients who have high fever (higher than 102) should also get in touch with a physician immediately, he said.
He said patients would also receive detailed information about how often fentanyl patches should be replaced -- including replacement of patches that fall off accidentally.