FDA Renews Warnings on Pain-Relief Patch

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In some cases, patients used the patch incorrectly -- replacing it more frequently than directed, using more patches than prescribed, or applying heat to the patch. These all can cause dangerously high fentanyl levels in the blood, according to the FDA.

The patch is often prescribed to patients who can't tolerate pills, Rappaport said.

Many patients are getting prescriptions for the patch from their primary-care doctors, who may be unaware of the associated dangers, Rappaport said. There are only about 4,000 pain specialists in the United States to treat the more than 60 million Americans with chronic pain. That's why doctors need to understand the dangers associated with the patches, he said.

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There are many doctors who need access to these drugs, Rappaport added. "The last thing we want to do is limit the availability of good analgesics to chronic patients. If anything, we have under-treatment of chronic pain in this country," he said.

In addition to educating doctors, the FDA is asking manufacturers of the patches to update information and develop a medication guide for patients, Rappaport said.

The patch is made by Johnson & Johnson and sold as Duragesic. However, there are four generic versions of the patch sold by other manufacturers.

The FDA has issued a Public Health Advisory and Health Care Professional Sheet that includes the following information:

• Fentanyl patches are only for opioid-tolerant patients who have chronic pain not well controlled by other pain medicines. The patches should not be used to treat sudden, occasional or mild pain, or pain after surgery.
• Patients and doctors need to know the signs of an overdose: trouble breathing or slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If any of these symptoms occur, patients should get immediate medical attention.
• Patients should tell their doctor about all the medicines they take. Some medicines can interact with fentanyl, causing dangerously high fentanyl levels in the blood and life-threatening breathing problems.
• Patients and their caregivers should be told how to use fentanyl patches.
• Heat can increase the amount of fentanyl that reaches the blood, causing life-threatening breathing problems and death. Patients using the patch should not use heating pads, electric blankets, saunas, or heated waterbeds, or take hot baths or sunbathe while wearing a patch. A doctor should be called if the patient wearing the patch has a temperature higher than 102 degrees.

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