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FDA Issues Second Warning on Pain Patch

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image Pain killing patch

Health officials issued a second warning Friday on the improper use of the Johnson & Johnson Duragesic pain-killing patch and its generic versions. The US Food and Drug Administration said that despite its July 2005 warning, deaths and life-threatening side effects arising from the use of the patch continue to be reported.

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The July 2005 warning came after 120 patients using the pain patch died. The FDA issued its new warning since it appeared that doctors continue to prescribe the medicine inappropriately.

Although the incidence of new cases was described as “a small number” the FDA said it was concerned because these were all preventable. The agency is still working to get an exact tally of problems related to the misuse of pain patches.

Pain patches deliver a potent narcotic called fentanyl through the skin. The product was approved for use on patients having persistent, moderate-to-severe pain and whose body systems are already used to narcotic-based pain medicine. Once a patch is applied, it can give relief from pain for up to three days.

The most common use for pain patches is among cancer patients. However, some doctors have inappropriately prescribed it for mild pain arising from headaches or after surgery.

In addition, patients misused the patch. Modes of misuse include:

* Replace it more frequently than instructed by the physician
* Apply more patches than directed
* Expose the patches to heat, such as from a heating pad or hot tub
* Drink alcohol while using the patch

All of these modes can increase the fentanyl in the blood to dangerous levels. It is important, therefore, for doctors to prescribe them only for appropriate cases, and to instruct patients carefully about the correct use.

There are about 60 million Americans who suffer from chronic pain.

The FDA is asking all manufacturers of fentanyl pain patches to strengthen the warnings and safety information on the product and to produce a patient-friendly guide to proper use that would highlight the risks of misuse.

Symptoms of fentanyl overdose include having difficult, slow or shallow breathing; slow heartbeat; extreme sleepiness; difficult walking or talking; feeling faint or dizzy; and having cold, clammy skin.

Safety Tips:
* Use fentanyl only as directed by the physician. Fentanyl is a very strong narcotic painkiller and should never be used to treat short-term pain.
* Store unused patches in a secure place out of children’s reach.
* Dispose of used, defective, or unneeded patches properly: fold the patch on its sticky side and flush it down the toilet.
* Avoid alcohol and exposure to heat while wearing a patch.

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