What is Duragesic Pain Patch?
Duragesic® is the trade name for a pain-medication patch containing fentanyl, a potent opioid analgesic. Duragesic is a transdermal system—the medicine, fentanyl, is absorbed through the patient’s skin and into the bloodstream, providing pain relief for up to three days (72 hours) from a single patch application.
The Duragesic patch consists of four layers: (1) a backing layer of polyester film; (2) a drug reservoir of fentanyl and an alcohol gel with hydroxyethyl cellulose (to enhance the drug delivery rate); (3) an ethylene-vinyl acetate copylymer membrane that controls the rate of fentanyl delivery to the skin surface; and (4) a fentanyl containing silicone adhesive material.
Once fentanyl is absorbed into the skin, it forms a depot of drug in the upper layers of the skin. It is absorbed by the lungs and fat tissue, and then slowly released in to the systemic circulatory system. Serum concentrations increase gradually following initial Duragesic application, generally leveling off between 12 and 24 hours and remaining relatively constant, with some fluctuation, for the remainder of the 72-hour application period. Absorption also continues up to 12 hours after the removal of a Duragesic patch.
Fentanyl increases the patients’ tolerance to pain and decreases the perception of suffering. This drug is extremely powerful, with an analgesic potency of about 200 times stronger than morphine. Because of its potency, Duragesic is suitable only for the management of severe, chronic pain (such as cancer pain) that requires continuous opioid administration and cannot be managed with less potent medicines such as acetaminophen-opioid combinations and nonsteroidal analgesics.
Fentanyl was found to be a good choice for transdermal application because of its physicochemical properties and high analgesic potency. The drug’s low molecular weight and highly lipohilic nature enables it to be readily absorbed (46-66% of a given dose) through the skin and subsequently distributed throughout the body. The degree of absorption depends on where the patch is applied.
Since Duragesic hit the marketplace in 1991, studies have shown continued high numbers of overdoses involving transdermal delivery of fentanyl. The most serious side effect is respiratory depression, which can be fatal.
In a study published in 2000, the Los Angeles County Department of the Coroner analyzed 25 cases involving fentanyl-related deaths. The author notes that the Los Angeles County Coroner’s Office evaluates nearly one case each month involving fentanyl patch-related death. Another study that same year identified 61 cases of transdermal drug overdoses in a Regional Poison Information System over a five-year period.
Several case reports have described the development of life-threatening overdose caused by a heating pad or rise in body temperature. Frolich et al. reported a narcotic overdose in a patient that was using a warming blanket to relieve pain following surgery. See M.A. Frolich et al., Opioid Overdose in a Patient Using a Fentanyl Patch During Treatment with a Warming Blanket, 93 ANESTH. ANALG. 647-48 (2001) (unable to obtain hard copy). The increase in absorption may account for other heat-related toxicity associated with transdermal fentanyl. G. Newshan, Heat-Related Toxicity with the Fentanyl Transdermal Patch, 16 J. PAIN SYMPTOM MGMT. 277-78 (1998) (unable to obtain hard copy).
One study, in 2003, examined the effect of heat on transdermal fentanyl absorption. The authors concluded that increases in skin temperature may result in increased systemic absorption of fentanyl. Therefore, warming blankets and heating pads should not be either used in conjunction with, or placed over Duragesic patches.
The design/manufacturing defect most applicable to our case is an improper sealing of one edge of the Duragesic patch, resulting in millions of patches being recalled. During 2004, ALZA (through Janssen) initiated two large Class I recalls of Duragesic for this exact reason. The first was February 17, 2004 at which time Duragesic Control No. 0327192 (75 mcg/hr) was pulled from the market. The cited reason was a potential seal breach on one edge of the patch, which could result in fentanyl leaking from the patch. This recall included about 440,000 patches.
On April 5, 2004, Janssen expanded its recall of Duragesic to include 2.2 million patches (Control Numbers 0327192, 0327193, 0327294, 0327295, and 0330362). Again, the reason cited was the potential for a breach of the seal, which would result in fentanyl leakage. Janssen sent a “Dear Healthcare Professional” letter to inform of the expanded recall.
A leak of fentanyl from a Duragesic patch could cause patients to receive either too much or too little of the drug. If the fentanyl seeps out of the patch before its application to the skin, patients may receive too little medication to adequately treat their pain. In this situation, patients used to a specific does may experience withdrawal effects including sweating, sleeplessness, and abdominal discomfort.
Conversely, fentanyl leaks that occur while the patch is on the skin expose patients to a potentially life-threatening overdose of fentanyl. Duragesic is designed to deliver only a controlled amount of fentanyl into the patient’s skin. Patients wearing a defective patch that leaks fentanyl directly onto the skin will receive too much of the medication. If this occurs, patients could experience minor complications such as sedation, drowsiness, and nausea. Fentanyl overdose may result in more serious complications, including fatal hypoventilation (respiratory depression) or cardiac arrest.
When Jansen placed Duragesic on the market in 1991, reports of toxicity due to fentanyl overdosing were fairly common. In fact, one study in California of 112 deaths associated with fentanyl concluded that the general availability of the drug may be responsible for the high incidence of overdoses.
Largely because of its potency, fentanyl has been misused since it was first introduced. A number of studies have noted the high potential for abuse of fentanyl as a substitute for heroin or other illegal drugs. Recreational abuse of fentanyl is extremely dangerous due to the low concentrations necessary to induce respiratory depression. Several overdose deaths of health professionals and non-health professionals have been reported involving ingestion, injection, or smoking of fentanyl transdermal patches.
In 2004, the FDA influenced Janssen and ALZA to issue two Class I Recalls of Duragesic, “due to improper sealing of one of their edges,” which could result in a life-threatening overdose of fentanyl. Govt Regulation 7. Yet, this was not the first time the FDA encountered problems with the companies’ handling of Duragesic. In fact, prior to the recalls in 2004, the FDA has required Duragesic labeling revisions 13 times. And, as recently as July 2005, the FDA issued a Public Health Advisory concerning the use of Duragesic Patches in response to reports of deaths in patients using the patch.
Beginning in 1994, the FDA sent ALZA a “warning letter” identifying certain violations and deviations from Good Manufacturing Practices (GMP) regulations under the Food and Drug Act. This prompted the company to issue a letter to all health care professionals warning of Duragesic misuse.
Following Janssen’s “voluntary” recall of Duragesic in 2004, the FDA issued a “Safety Alert” warning that the recall was “due to a potential leak in the product seal,” which could result in skin exposure to fentanyl. Govt Regulation 6. The warning adds that “skin exposure to any leaked medication from a DURAGESIC patch may cause nausea, sedation, drowsiness, or potentially life-threatening complications.” Janssen also wrote a letter to “Healthcare Professional[s]” informing them of the expanded recall in April 2004.
To contact a Top Chicago Personal Injury Lawyer with the knowledge and experience to help you with a potential lawsuit related to a Duragesic or Fentanyl-related overdose, call Passen & Powell at (312) 527-4500 or fill out a Free Case Evaluation.