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Fentanyl, an opioid pain medication 100 times stronger than morphine, is used during surgery for anesthesia and to treat chronic pain patients. The drug is usually administered to patients through the use of a patch, a method approved by the FDA in 1990, when a patient's pain becomes untreatable through the use of other, less powerful, medications. Initially, the fentanyl patch was most commonly used by people with cancer, but more recently has become widespread, with doctors prescribing the drug for many other types of pain patients. It is now being reported that the amount of fentanyl contained within these patches can cause death if delivered in an uncontrolled manner such as when the patch leaks or when it is defective in some other way.
The Duragesic patch made by Johnson & Johnson subsidiary Alza Corporation was, for many years, the only approved fentanyl patch. However, there now are numerous generic versions of the fentanyl patch, including Sandoz (also manufactured by Alza), Mylan, Watson and Actavis. The patches are designed to deliver a steady dose of fentanyl for 3 days, and all come in dosage strengths of 12.5, 25, 50, 75 and 100 mcg/hr. But over the last couple years, the FDA has received hundreds of reports of fatalities linked to fentanyl patch use. The cause of these deaths can be due to seal breaches allowing fentanyl gel to leak from the patch, known as the "fold-over defect," malfunction of the rate control membrane or other defects. The FDA is currently investigating these deaths.
Fentanyl Pain Patches Under Scrutiny:
- Duragesic
- Abrika
- Actavis
- Mylan
- Sandoz
In 2004, Alza Corporation and Janssen Pharmaceutica recalled 5 lots of patches because of "fold-over defects" leading to leakage of the fentanyl gel contained within the patches. Upon investigation by the FDA, numerous other defects were discovered including what is called a "stringer leaker" defect. It is now clear that many other lots, of all sizes, that were not recalled suffered from leak defects. Since the initial recall, manufacturers have continued to produce and distribute defective patches. In fact, on February, 12th, 2008, Johnson & Johnson recalled approximately 32 million patches because of possible leak defects including the Duragesic and Sandoz brands. On Monday, February 18, 2008, Actavis Inc., voluntarily recalled 14 lots of its fentanyl transdermal patches sold in the United States because of leak defects. In each of these recalls, the manufacturers warned that exposure to the gel contained in the patch could lead to serious injury or death.
Symptoms of a Fentanyl overdose include:
- Trouble with breathing
- Slow heartbeat
- Severe sleepiness
- Cold, clammy skin
- Trouble with walking or talking
- Feeling faint, dizzy, or confused
- Death
In addition to reports of leaking patches, the FDA has investigated deaths and life-threatening side effects in patients who never should have been prescribed the patch. In December, 2007, reports of improper prescribing of the patch prompted the FDA to issue its second Public Health Advisory regarding fentanyl pain patches, which stated that "reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should not be prescribed."
On June 19, 2007 a jury awarded $5.5 million to the family of a 28-year-old Florida man who died while wearing a Duragesic fentanyl pain patch. The trial was the first ever in a federal court against the makers of any fentanyl transdermal pain patch. Tests showed that the victim, Alan Henderson, who suffered from chronic hip pain due to a car accident and wore the patch on his arm, had three times the lethal dose of fentanyl in his system at the time of his death.
If you or a family member have been hurt or if you have lost someone as a result of using any brand of fentanyl transdermal pain patch, please contact us today.
CLICK HERE to contact us today, or send an email to Info@HelpingTheInjured.com
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