Fentanyl is a powerful opoid (opiate based) analgesic (pain killer) used for management of extreme pain. Fentanyl is 81 times more powerful than morphine: so powerful that it was first introduced to the market in during the 1960s as an anesthetic.
Fentanyl is also prescribed for “breakthrough pain;” this term refers to extreme pain that lesser painkillers cannot contain. Many cancer patients will exhibit breakthrough pain during the course of their battle with the disease. For its initial purposes, fentanyl was a powerful addition to the modern battery of pharmaceutical tools for pain.
Use of the drug was extended into the management of chronic pain through the introduction of the fentanyl patch. This device is a transdermal patch, attached to the patient who has chronic and relatively severe pain. The patch is designed to introduce fentanyl into the patient’s fat cells, which then distribute the drug gradually over a period of 72 hours. It was approved by the FDA in 1990.
There have been a number of problems with the fentanyl transdermal patch, which have led to investigations by the FDA, lawsuits, and several product recalls. There have been numerous reports of patients suffering respiratory suppression, which has been fatal in several instances. There have also been a number of problems with overdoses, thought to be the result of product design in some of the patches.
In 2005, the FDA announced that it was investigating 120 deaths possibly related the use of fentanyl patches. The Agency has also demanded that the drug packaging include a black box warning about proper use of the drug and its potential dangers. In 2007 a Florida jury ordered a $5.5 million award of damages to the father of a 23 year old man who was wearing the patch for chronic hip pain and suffered a fatal overdose. There are several other active lawsuits over fentanyl’s potentially lethal effects.
Because the drug has been on the market so long, it is available in generic form. Johnson & Johnson markets a branded fentanyl patch under the name Duragesic. On February 12 2008 Johnson and Johnson announced the recall of Duragesic patches of certain dosages because of the possibility that the gel containing the drug could leak from the patch, resulting in overdose.
Novartis also recalled their patch, marketed under the name Sandoz. Five days later on February 17th Actavis recalled certain batches of its fentanyl patches because of the danger of leakage.
That is just the most recent action taken by drug manufacturers. There have been five recalls of the patch since 1995. The marketers of Duragesic have been instructed by the FDA to alter their packaging information on several occasions. Nevertheless, Johnson and Johnson sold $1.6 million in Duragesic patches in 2007; it is likely that they will return to the market with yet another design that is meant to make the patch less likely to cause a spontaneous overdose.
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