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Pain patch required special monitoring

The FDA's probe into deaths involving painkiller fentanyl underscores the lack of oversight for new drugs after they are approved for sale.

Nov 27, 2005 | www.miami.com

Dory Bauler prides herself on staying active despite painful back problems. But earlier this year, she was getting so short of breath that she could barely walk. Doctors could find nothing wrong.

It never occurred to them that the medicinal patch she was using to deliver pain relief might also be poisoning her.

''I was just shutting down,'' said Bauler, 76, a retired paralegal from Laguna Woods, Calif., who suffers from a severe curvature of the spine.

Bauler's patch was delivering fentanyl, a narcotic many times more powerful than morphine. Like morphine and other opioid drugs, fentanyl controls pain but also reduces respiratory function. Luckily, Bauler figured out what was happening in time to stop using the drug. Too much fentanyl can shut down the respiratory system.

The leading brand of the fentanyl patch is Johnson & Johnson's Duragesic; last year, pharmacists filled more than 4 million prescriptions for it.

The drug was developed to help people in extreme, constant pain. Misuse can be lethal.

The fentanyl patch illustrates a broad and still-unresolved problem with the nation's system for protecting patients against drug risks: Neither the FDA nor the pharmaceutical industry has a comprehensive system for monitoring what happens after a new drug is approved for market.

Sometimes, as with the highly publicized discovery of heart and stroke risks associated with the painkiller Vioxx, the problem is that dangers show up only after millions of people begin using a drug. At other times, as with fentanyl, the problem is that a drug approved for one purpose can be prescribed and used for other purposes. Known as off-label use, the risks are not always understood.

Cancer patients, for whom the fentanyl patch was developed, are usually monitored closely by a physician. Often, however, the patches are being prescribed for other conditions, sometimes without close monitoring.

The FDA says it is investigating about 130 fatalities that occurred over a 15-year period. Results of autopsies in Los Angeles and Florida suggest the number of fentanyl-related deaths may be much higher.

''There are hundreds more cases not evaluated by the FDA,'' said Bruce Goldberger, director of toxicology at the University of Florida Medical School.

In Los Angeles County, criminalist Daniel Anderson of the coroner's office said the ''vast majority'' of the 237 people whose deaths involved fentanyl had used the patch. The deaths occurred over a 5 ½-year period.

Of those, 127 were classified as accidental, suggesting that patients misunderstood how to avoid the drug's risks.

In Florida, state authorities reported 115 deaths from fentanyl poisoning in 2004, records show. Goldberger, whose office handles about one-fourth of the autopsies in the state, said the majority involved the patch.

Drug abuse involving fentanyl also is on the rise. Emergency room mentions of the drug rose from 28 in 1994 to 1,506 last year, according to the federal Substance Abuse and Mental Health Services Administration.

Duragesic sales more than doubled from 2000 to 2004 as manufacturer Johnson & Johnson touted its safety in advertising to doctors that the FDA called ''misleading.'' Yet as early as 2001, a drug safety group had publicly warned that patients on the patch were dying of overdoses.

It took another four years for the FDA to issue its own nationwide alert, on July 15.

Dr. Robert Meyer, head of the FDA office that oversees painkillers, said that earlier this year safety officers noticed a trend of adverse reactions involving the drug.

''The system in place, though never ideal, does work well,'' Meyer said. ``The FDA did the right thing in [issuing] its communication. One of the things we need to think about in the future is continuing communications in terms of drugs like this that have some safety concerns.''


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