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U.S. health officials issued the second warning since 2005 on Friday about deaths from misuse of Johnson & Johnson’s Duragesic pain-killing patch or generic versions.

Despite a July 2005 warning, the Food and Drug Administration “has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it,” the agency said.

The patch delivers a potent narcotic called fentanyl through the skin. The product was approved in 1990 for patients with persistent, moderate-to-severe pain and whose bodies are used to opioids. That means they have used another strong opioid pain medicine around the clock for a week or longer.

Duragesic and generic copies are most commonly used to treat cancer patients, the FDA said, but some doctors have been inappropriately prescribing the patch for occasional or mild pain, post-surgical pain, or for headaches.

The FDA also said some patients had replaced the patch more often than directed, applied more patches than prescribed or exposed them to heat such as from a heating pad or hot tub. All of those scenarios can lead to dangerously high fentanyl levels in the blood.

“While these products fill an important need, improper use and misuse can be life-threatening. Therefore, it is crucial that doctors prescribe these products appropriately and that patients use them correctly,” said Dr. Bob Rappaport, director of anesthesia, analgesia and rheumatology products at the FDA.

FDA officials said they were working to tally exactly how many problems were related to patch misuse, but could not provide a number on Friday.

Since the 2005 warning, there have been “really just a small number of cases that are very concerning because they are preventable,” Rappaport said.

As many as 60 million Americans experience chronic pain, Rappaport said.

The agency said it was asking all manufacturers of fentanyl patches to update safety information and issue a patient- friendly guide to highlight the risks.

Greg Panico, a spokesman for Johnson & Johnson unit Ortho-McNeil, said the company would strengthen the product warnings and develop the patient guide.

“We’ve been working with the FDA on these changes,” he said.

The company saw a significant decline in unapproved use of Duragesic from 2005 through June 2006 and no increase in the number of health problems reported during that time, Panico said.

Michael Cohen, president of the nonprofit Institute for Safe Medication Practices, said the new FDA warning “will educate some doctors, but it’s not enough. I think we need to do more.”

Cohen said other steps could help such as requiring pharmacists to discuss proper use with patients, or having company salespeople do more to get the message to doctors.

Signs of a fentanyl overdose may include breathing trouble, slow or shallow breathing, slow heartbeat, severe sleepiness, cold, clammy skin, trouble walking or talking, or feeling faint, dizzy, or confused. Patients should get immediate medical attention if those signs occur, the FDA said.

Mylan Inc, which sells a generic fentanyl patch, supports FDA efforts to encourage safe use, company spokesman Michael Laffin said via e-mail. Mylan’s version does not have the potential to leak and cause a potentially fatal overdose as do competitors that are “gel-filled” patches, he said.

The Food and Drug Administration today issued a new safety warning for a potent painkiller that comes in a patch and has been linked to hundreds of accidental overdose deaths, in many instances because doctors have mistakenly prescribed the narcotic to the wrong kinds of patients.

The warning was unlikely to satisfy patient safety advocates, who have been urging the agency to restrict the use of the fentanyl medication patch. An earlier warning by the FDA in 2005 did not do enough to reduce the risk to patients, all sides acknowledge.

However, the agency said it did not want to sharply restrict the use of the fentanyl patch because that could keep many patients who would benefit from getting relief for their pain.

The fentanyl patch is a widely used painkiller that delivers a narcotic up to 100 times more powerful than morphine through the skin for three days at a time. It was originally intended for cancer patients and others with severe chronic pain who were already taking potent opiate-based painkillers. But the FDA said the patch is also being prescribed to many who don’t really need it even people suffering from nothing more than headaches.

“In some cases, prescribers are giving the patches to patients who are not opiate-tolerant, for the treatment of post-surgical pain or for mild pain,” said Dr. Bob Rappaport, who oversees the FDA division responsible for painkillers. “We’ve even seen cases where it’s been prescribed for a headache.”

As part of the safety warning, drug makers will be required to develop a safety guide for patients, which will be dispensed with the prescription. Rappaport said some patients are not aware that heat can dramatically increase the rate at which the painkiller flows into the bloodstream. A heating pad applied near the patch or even a hot shower can cause an overdose.

Too much fentanyl can cause life-threatening breathing problems, and even death. The drug is widely known by its brand name, Duragesic, but nowadays generic versions account for most of the estimated 4.7 million prescriptions written annually. All forms of the patch should be used with great caution, said Rappaport.

The FDA said it is trying to determine how many people have been killed or sickened accidentally by the patch, he added, but the agency cannot yet supply such a statistic. However, this summer a medical journal article analyzing reports to the FDA identified fentanyl as the second-deadliest drug. Another painkiller, oxycodone, was the most widely cited. The article found 3,545 deaths linked to fentanyl from 1998 to 2005, although some of those likely involved other forms of the drug, including a lollipop. By comparison, researchers cited only 932 deaths linked to Vioxx, the painkiller whose recall prompted safety reforms at the FDA.

More important than the number of cases, said Rappaport, is the fact that many of the deaths are entirely preventable.

For the second time in two years, U.S. health officials are warning of reports of deaths and dangerous side effects tied to misuse of fentanyl skin patches that are prescribed to treat chronic pain.

The patches deliver a potent pain killer containing the narcotic fentanyl. They are primarily used by cancer patients who are tolerant to the side effects of narcotic pain medications, according to U.S. Food and Drug Administration officials who issued Friday’s warning.

“There are a small number of cases [of deaths and life-threatening side effects] that are very concerning, because they are preventable,” Dr. Bob Rappaport, the FDA’s director of the Division of Anesthesia, Analgesia and Rheumatology Products, said during a morning teleconference.

“Unfortunately, we are still seeing prescribers giving these patches to patients who are not opioid-tolerant, or for treatment post surgery, for mild pain. We’ve even seen cases for headache,” Rappaport said. “There are still cases of patients who are not using the product correctly.”

Rappaport could not say how many cases of death or life-threatening side effects have been caused by fentanyl patches since the agency issued its first warning in July 2005.

Fentanyl skin patches are only for use with patients who have become used to narcotic drugs and are less likely to have side effects, such as difficulty breathing, Rappaport said. “That’s why somebody who has been on high-dose opioids for a long time can get large doses that would be a fatal dose in somebody who had never been exposed to opioids,” he said.

However, recent reports describe deaths and life-threatening side effects after patches were inappropriately prescribed to relieve pain after surgery, for headaches, and for occasional or mild pain in patients who were not opioid tolerant, he said.

In some cases, patients used the patch incorrectly replacing it more frequently than directed, using more patches than prescribed, or applying heat to the patch. These all can cause dangerously high fentanyl levels in the blood, according to the FDA.

The patch is often prescribed to patients who can’t tolerate pills, Rappaport said.

Many patients are getting prescriptions for the patch from their primary-care doctors, who may be unaware of the associated dangers, Rappaport said. There are only about 4,000 pain specialists in the United States to treat the more than 60 million Americans with chronic pain. That’s why doctors need to understand the dangers associated with the patches, he said.

There are many doctors who need access to these drugs, Rappaport added. “The last thing we want to do is limit the availability of good analgesics to chronic patients. If anything, we have under-treatment of chronic pain in this country,” he said.

In addition to educating doctors, the FDA is asking manufacturers of the patches to update information and develop a medication guide for patients, Rappaport said.

The patch is made by Johnson & Johnson and sold as Duragesic. However, there are four generic versions of the patch sold by other manufacturers.

The FDA has issued a Public Health Advisory and Health Care Professional Sheet that includes the following information:

• Fentanyl patches are only for opioid-tolerant patients who have chronic pain not well controlled by other pain medicines. The patches should not be used to treat sudden, occasional or mild pain, or pain after surgery.
• Patients and doctors need to know the signs of an overdose: trouble breathing or slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If any of these symptoms occur, patients should get immediate medical attention.
• Patients should tell their doctor about all the medicines they take. Some medicines can interact with fentanyl, causing dangerously high fentanyl levels in the blood and life-threatening breathing problems.
• Patients and their caregivers should be told how to use fentanyl patches.
• Heat can increase the amount of fentanyl that reaches the blood, causing life-threatening breathing problems and death. Patients using the patch should not use heating pads, electric blankets, saunas, or heated waterbeds, or take hot baths or sunbathe while wearing a patch. A doctor should be called if the patient wearing the patch has a temperature higher than 102 degrees.

“Fentanyl is a powerful, fast-acting pain inhibitor that, like all opioids, can stop the patient’s breathing at excessive doses,” said Edwin W. McCleskey, scientific officer at the Howard Hughes Medical Institute in Chevy Chase, Md.

Its use in hospitals is appropriate, because it can be carefully monitored, and overdose can be quickly relieved by an antagonistic drug, he said.

“Home use is obviously dangerous,” McCleskey said. “The fact that the temperature of the fentanyl patch alters the drug’s delivery rate means that the patient’s dose will vary with ambient temperature and skin temperature. Such variables and the fact that patients receiving this powerful drug are already very sick argue that the patients must be carefully supervised.”