Pain-Relief Patch Is Investigated in Patient Deaths

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July 16, 2005 www.latimes.com

Pain-Relief Patch Is Investigated in Patient Deaths

The FDA is looking into whether 120 cases could be the result of

unintentional fentanyl overdoses.

By Alonso-Zaldivar, Times Staff Writer

WASHINGTON — Federal regulators are investigating about 120 deaths

that may be linked to overdoses from a pain-relief patch that

administers a potent narcotic through the skin, the Food and Drug

Administration said Friday.

& 's Duragesic patch can provide up to three days'

relief from severe chronic pain, such as that experienced by bone-

cancer patients. But fentanyl, its active ingredient, is dangerous.

An overdose of the morphine-like drug can put a patient into a coma

and shut down breathing.

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Fentanyl gained international notoriety in 2002 when Russian

authorities trying to end a hostage crisis at a Moscow theater pumped

in a gas reportedly containing the drug. They intended to put the

hostages and their Chechen captors to sleep. Of the 750 hostages,

about 120 died, nearly all from breathing the gas.

FDA officials said they were investigating whether the deaths among

U.S. patients could be the result of unintentional fentanyl overdose.

Such overdoses could come about if patients and doctors did not

follow precautions contained in the prescribing literature, or label,

for the drug.

Other possible explanations include rare problems or defects with the

patches that would cause too much of the drug to be released into the

body too quickly. And since many patients taking fentanyl are

seriously ill, some of the deaths could also be the result of their

diseases.

Doctors and patients should be aware of the signs of fentanyl

overdose, which include trouble breathing or shallow breathing,

tiredness, extreme sleepiness, inability to think, talk or walk

normally, and feeling faint, dizzy or confused, the FDA said.

Patients experiencing the symptoms should get medical attention

immediately.

" The way people die is that it decreases the drive to breathe, so

people will not breathe effectively, " said Dr. Meyer, who

heads the FDA office that regulates painkillers. " It [can] make

patients very sedated or comatose. "

FDA officials said the agency announced the investigation in keeping

with its new commitment to give the public earlier warnings of

possible problems with prescription drugs.

The FDA has been criticized for taking too long to respond to

evidence of heart attack risks with Vioxx and other arthritis drugs,

and to evidence of suicide risks for teens taking antidepressants.

The fentanyl investigation is in its early stages, FDA officials

said, and the agency has reached no decision on whether the patches

should be recalled or their use limited. The agency issued a public

health advisory Friday underscoring the need for patients to follow

precautions.

" Some of the cases would seem to involve an overdose, " Meyer

said. " We understand that labeling is not always understood or

adhered to, and this is a way to reemphasize that these important

warnings should be heeded. "

A spokesman for & said the New Jersey company had

emphasized that Duragesic should be used with care.

" Patient safety is our first priority and it has been for the many

years we have sold the drug, " spokesman Doug Stokke said. " We have

consistently communicated to patients, caregivers and healthcare

professionals information regarding the safe and appropriate use of

Duragesic. "

Duragesic has been on the market since 1990, and the FDA said the 120

deaths reported to the agency spanned the entire period. Typically,

the FDA's reporting system picks up a fraction of serious drug

reactions.

Mylan Laboratories Inc. began marketing a generic version of the drug

this year.

Sales of brand-name Duragesic reached $1.2 billion in 2004, with more

than 4 million prescriptions filled, said the website drugtopics.com.

It ranked 24th in dollar sales among the top 200 drugs in 2004, and

93rd in the number of prescriptions.

Because of its risks, Duragesic and its generic equivalent carry a so-

called black box warning, the FDA's most emphatic.

On Friday, the agency underscored those warnings.

Doctors should prescribe the lowest effective dose of the medication,

the agency said. And fentanyl patches should not be used to treat

short-term pain or pain after an operation. Patients should not use

patches that are damaged or broken. They also should not drink

alcoholic beverages or sit in the sun while taking the drug, because

alcohol and a rise in body temperature can accentuate the narcotic

effects.

Stokke said & recently added to the warnings,

notifying doctors that Duragesic should not be used by patients who

could not tolerate opioid drugs.

People using the patches would include certain cancer patients, those

who have difficulty swallowing pills and those who have problems

injecting drugs.

" This is actually a useful drug, " said Dr. Lurie, deputy

director of health research for Public Citizen, an advocacy group

often critical of the FDA. " But it's also a particularly dangerous

drug. "