Improper use of painkiller patch can be lethal

The U.S. Food and Drug Administration on Friday cautioned patients and doctors about the improper and potentially fatal misuse of a skin patch is prescribed to treat chronic pain, and again issued a safety warning, saying the improper use continues to cause deaths and life-threatening breathing difficulty.

Announcing the warning in a statement yesterday the Federal health regulators said the skin patch that delivers a potent pain killer containing the narcotic fentanyl has been involved in hundreds of deaths.

The FDA said the widely used fentanyl patch was being wrongly prescribed by doctors and being misused by patients. The US health watchdog warned that using fentanyl skin patch outside of approved guidelines could result in deadly overdoses.

The US health agency warned the fentanyl skin patch poses unique risks that doctors and patients generally fail to understand. They also urged doctors to take care in prescribing the skin patch and to make patients fully aware about how to use it.

"There are a small number of cases [of deaths and life-threatening side effects] that are very concerning, because they are preventable," said Dr. Bob Rappaport, the FDA's director of the Division of Anesthesia, Analgesia and Rheumatology Products.

"Unfortunately, we are still seeing prescribers giving these patches to patients who are not opioid-tolerant, or for treatment post surgery, for mild pain. We've even seen cases for headache," Rappaport said. "There are still cases of patients who are not using the product correctly."

FDA first issued the warning in 2005 in regard to the safety of the Duragesic Fentanyl patch after 120 patients taking the drug died. Now, after receiving some reports of deaths and dangerous side effects tied to misuse of fentanyl skin patches, the health agency again issued the warning, urging the manufacturers of the patches to update information and develop a medication guide for patients.

Made by Johnson & Johnson and sold as Duragesic, the patch was developed for cancer patients who suffer severe chronic pain and in some cases have trouble taking oral form of drug.

The Duragesic Fentanyl patch’s purpose is to relieve severe chronic pain, such as for sufferers of rheumatoid arthritis. One patch relieves pain for up to 3 days.

The patch should only be used to treat patients who have already taken narcotic painkillers and find that short-action pain killers to do completely relieve their pain, FDA said.