The FDA said patients also accidentally overdose by using the patches incorrectly, such as putting on more than prescribed, replacing them too frequently, or getting them too hot.
"While these products fill an important need, improper use and misuse can be life-threatening," said FDA pain chief Dr. Bob Rappaport. "It is crucial that doctors prescribe these products appropriately, and that patients use them correctly."
The FDA first warned about improper patch use in 2005, when it announced that it was investigating 120 deaths.
Although FDA has investigated the new reports for several months, Rappaport refused to say yesterday how many additional deaths the agency has learned of since that first warning. He called the number of reports small but concerning because "they are preventable."
Yesterday, the FDA said it had ordered patch makers to create special medication guides that will come with every box, spelling out proper use in easy-to-understand language.
The consumer advocacy Institute for Safe Medication Practices highlighted last summer some cases in which mistakes happened. One patient died after being given a patch for post-surgery pain despite having pneumonia and being new to narcotics.
Two others survived, an elderly man taken to the emergency room after being given a patch with painkillers, and an elderly woman who became delirious while wearing several patches at once.
The FDA's main message yesterday: Do not prescribe fentanyl patches to anyone new to opioids, the painkiller family that includes morphine. Absorbing fentanyl through the skin is a powerful way to deliver the potent drug, and thus poses serious risk to anyone not already opioid-tolerant, Rappaport explained.
But Rappaport said the FDA isn't considering curbs on prescribing because there is a great need for the patches among the millions of chronic pain sufferers, few of whom get care from pain specialists.
