On Dec. 21, 2007, the FDA issued its second warning regarding the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin. Over two years prior, in July 2005, FDA issued a similar warning emphasizing that the directions on the product label and on the patient package insert should be followed exactly in order to avoid overdose.

The patch is marketed as Duragesic by Johnson and Johnson, and generic versions are sold by other pharmaceutical manufacturers.

The fentanyl skin patch contains the opioid fentanyl, a potent narcotic. The patch was approved by the FDA in 1990 for use in people with persistent, moderate-to-severe pain who have become opioid-tolerant—meaning that they have been using another strong opioid narcotic for pain around-the-clock for a week or longer. The skin patch is most commonly prescribed for people with cancer.

Signs of fentanyl overdose include trouble breathing, or slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. Recent reports to describe deaths and life-threatening side effects after health care professionals inappropriately prescribed the patch or after people used the patch incorrectly.

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