A public health advisory on Duragesic (fentanyl) was issued on July 15, 2005 by the U.S. Food and Drug Administration while the agency was investigating about 120 deaths that may have been related to the use of the transdermal pain patches.
In a statement, the FDA said in part: "The agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product.
It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products ..." (See the full FDA statement below.)
The FDA was looking into reports of deaths and serious side effects caused by overdosing and cited deaths among patients who took the brand name Duragesic, made by a division of Johnson & Johnson, and fentanyl, the generic form of the opioid analgesic manufactured by Mylan Laboratories.
According to one report, in the health news website medpagetoday.com, the FDA said it "has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product."
Kline & Specter, PC, handled Duragesic cases and is a national leader in product liability and pharmaceutical litigation.
The FDA urged doctors to prescribe the Duragesic/fentanyl skin patches at the lowest doses necessary. It issued the following important patient information:
- Fentanyl skin patches should not be used to treat short-term pain, pain that is not constant, or for pain after an operation. Fentanyl skin patches should only be used by patients who are already taking other narcotic painkillers (opioid tolerant), and who have chronic pain that is not well controlled with shorter-acting painkillers.
- Patients who are using the fentanyl skin patch and their caregivers should be told about the directions for safe use of the patch and should follow the directions exactly. These directions are provided in the patient package insert.
- Patients who are using the fentanyl skin patch and their caregivers should be told about safe methods for storage and disposal of used, unneeded or defective fentanyl skin patches. Fentanyl skin patches should be stored in a safe place and kept out of the reach of children. Safely dispose of used, unneeded or defective fentanyl skin patches by folding the sticky side of the patch together (until it sticks to itself) and flushing it down the toilet.
- Health care professionals who prescribe the fentanyl skin patch and patients who use the fentanyl skin patch and their caregivers should be aware of the signs of fentanyl overdose. Signs of fentanyl overdose include trouble breathing or shallow breathing; tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused. If these signs occur, patients or their caregivers should get medical attention right away.
- A patient using the fentanyl skin patch may have a sudden and possible dangerous rise in their body level of fentanyl or have a stronger effect from fentanyl if they: use other medicines that affect brain function; drink alcohol (beer, wine or distilled spirits); have an increase in body temperature or are exposed to heat; or use other medicines that affect how fentanyl is broken down in the body. These factors are described further in the product label.
