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FDA Slow to Sound Alarm on Pain Drug

Fentanyl's overdose rate and side effects show holes in monitoring medicine on the market.

November 25, 2005|Ricardo Alonso-Zaldivar | Times Staff Writer

WASHINGTON — Dory Bauler prides herself on staying active despite painful back problems. But at one point 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 skin 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 in Orange County, who suffers from a severe curvature of the spine. "There were literally times I felt I wasn't getting any oxygen at all."

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 -- and too much fentanyl can shut down one's breathing entirely. Luckily, Bauler figured out what was happening in time to stop using the drug.

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 with extreme, unremitting pain, such as cancer patients. But it is increasingly being used for other medical conditions and, in some cases, by drug abusers.

Misuse can be lethal.

In the last six years, the Los Angeles County coroner's office has investigated more than 230 deaths involving fentanyl. Of the deaths, records show 127 were classified as "accidental"-- suggesting that the victims inadvertently had taken too much. And evidence from other states and the Food and Drug Administration suggests there may be many more such cases nationwide.

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. In other cases, as with fentanyl, the problem is that a drug approved for one purpose and in one context can be prescribed and used for other purposes. Known as off-label use, the risks of such use are not always understood.

"You've got a spectrum of the [drug safety] problem here," said Dr. Alastair J.J. Wood, associate dean at Vanderbilt University Medical School and an advisor to the FDA. "There isn't one easy solution. You need to have doctors think through whether this is the appropriate medicine for the patient."

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

The FDA says it is investigating about 130 fatalities that occurred over a 15-year period. Evidence from autopsies in Los Angeles and Florida suggests the number of fentanyl-related deaths may be much higher. The federal reporting system picks up a fraction of bad drug reactions.

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

In Los Angeles County, criminalist Daniel T. Anderson of the coroner's office said the "vast majority" of fentanyl-related deaths involved the patch. The deaths occurred over a 5 1/2 -year period ending this summer.

For the 127 classified as accidental, it is believed that patients often misunderstood how to avoid the drug's risks.

"Typically, the people we see here are people who have a legitimate use for the patch," Anderson said. He had called attention to overdose deaths involving the Duragesic patch in a professional journal article published in 2000.

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 cases involving the drug rose from 28 in 1994 to 1,506 last year, according to the federal Substance Abuse and Mental Health Services Administration.

"It is definitely a neglected drug safety problem," Goldberger said.

As Congress weighs changes to strengthen the drug safety system, the history of the fentanyl patch shows that the FDA and many in the medical community knew of risks but failed to closely monitor the growing use of a potent narcotic.

Duragesic sales more than doubled from 2000 to 2004, as manufacturer Johnson & Johnson promoted it as safe in advertising to doctors that the FDA called "misleading." With $1.2 billion in sales in 2004, Duragesic surpassed Vioxx, according to, a pharmaceutical website.

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