The fentanyl pain patch is a fentanyl transdermal patch used for the management of chronic pain. The patches are sold in four different strengths (2.5, 5, 7.5 and 10 mg. per patch). Fentanyl is the active ingredient for pain relief and it is an extremely powerful opioid pain medication. On a weight-for-weight basis, fentanyl is 50 to 100 times more potent than morphine. The patches have four layers, a polyester backing which overlies a drug reservoir composed of fentanyl and an alcoholic gel. A release membrane, in direct contact with the skin, controls the drug’s rate of release and the product is held in place by a final layer of adhesive. The fentanyl patch was approved by the Food & Drug Administration (FDA) in 1990. The approved indication for the patch is limited to treatment of persistent moderate to severe pain. The patch was initially prescribed primarily for cancer patients, but more widespread use for other types of pain has become common.
The fentanyl patches are easy for patients to use. The patch is applied to the skin and delivers fentanyl through the skin. The drug is slowly absorbed into the bloodstream through the skin and can relieve pain for up to three days from a single patch application. Typically, it can take up to 12 to 18 hours for the patch to reach the peak of pain relief, although some early pain relief can occur at four to six hours after the first administration. Additional information on the proper use of fentanyl pain patches can be found on the FDA’s website at http://www.fda.gov/fdac/features/2006/206_fentanyl.html.
The Duragesic® patch made by Johnson & Johnson subsidiary Alza Corporation was, for many years, the only approved fentanyl patch on the market. Today, there are numerous generic versions of the patch, including Mylan, Sandoz, Watson and Actavis. Each patch is intended to deliver a steady dose of fentanyl for 3 days. However, the amount of fentanyl contained within the patch can cause death if it is delivered in an uncontrolled manner (for example, if the patch leaks or if the patch is defective in some way).
In recent years, the FDA has received reports of fatalities linked to fentanyl patch use. In fact, the FDA in 2006 began investigating deaths and overdoses that have occurred with both the brand-name and generic fentanyl patches. Prior to 2006, the FDA had issued a public health advisory on the fentanyl patch. The advisory focused on improving education about the signs and symptoms of an overdose, proper patch application, drug interactions, proper storage and disposal of the patch, and safeguards for children. The reason for the advisory in part was due to the significant risks of depressed breathing that can cause unexpected death from patch use. Signs and symptoms of a possible overdose include trouble breathing or shallow breathing, extreme sleepiness or sedation, an inability to walk or talk normally, and feeling faint, dizzy, and confused. People who experience any of these symptoms should seek emergency medical attention immediately. The removing of the patch will not reverse the problem because the drug is still absorbed into the body for more than 17 hours after the patch is removed.
Fentanyl patches were recently recalled in February 2008, by Johnson & Johnson due to concerns that the patches contained defects that caused them to leak increased amounts of the drug into patients’ bloodstreams. In all, the company recalled 32 million patches and the recall included Duragesic® and Sandoz brands. In addition, on February 18, 2008, Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group HF, announced that 14 lots of fentanyl transdermal system CII patches sold in the United States were being voluntarily recalled from wholesalers and pharmacies because of leak defects. In each of these recalls, the manufacturers warned that exposure to the gel in the patch could lead to serious injury or death.
In December 2007, the FDA issued its second Public Health Advisory regarding the fentanyl pain patches which stated that “reports indicate that doctors have inappropriately prescribed the fentanyl patches 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.” Such inappropriate prescribing could lead to injury and even death. Additional information on this second Public Health Advisory can be found on the FDA’s website at http://www.fda.gov/cder/drug/advisory/fentanyl_2007.htm.
The law firm of Blizzard, McCarthy & Nabers is involved in litigating these cases for its clients. If you or a loved one has suffered injury, harm or death as a result of the use of any fentanyl patch, please contact us by using the form below or dialing (866) 879-3040.
Secure 128-bit SSL Encrypted Email Communication
