FDA renews alert on painkiller patch

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FDA renews alert on painkiller patch

http://www.latimes.com/news/nationworld/nation/la-na-

patch22dec22,1,6667669.story

By Alonso-Zaldivar, Los Angeles Times Staff Writer

The fentanyl patch, which delivers a powerful narcotic through the

skin, is the subject of an FDA alert.

The drug, which the agency says has been misused and wrongly

prescribed, is a suspect in 3,500 deaths. Heat can increase the

absorption rate.

The government issued a new safety warning Friday for a skin patch

containing a potent painkiller that has been implicated in hundreds

of deaths, saying the patch poses unique risks that doctors and

patients often fail to understand.

The Food and Drug Administration said the widely used fentanyl patch

was being wrongly prescribed by doctors and being misused by

patients unaware that something as routine as taking a hot shower

while wearing the patch could trigger a potentially fatal overdose.

A study published in a medical journal last summer identified

fentanyl, a narcotic up to 100 times more powerful than morphine, as

the suspect drug in more than 3,500 accidental deaths reported to

the FDA from 1998 to 2005. Safety advocates said the agency's latest

warning, which echoes an alert issued in 2005, was too little, too

late.

The patch was developed for cancer patients who suffer severe

chronic pain and in some cases have trouble swallowing pills. But

Dr. Bob Rappaport, head of the FDA division that oversees

painkillers, said some doctors had been prescribing the patch to

patients who didn't need such a powerful narcotic -- and in at least

one case, even used it to treat headaches.

Patches can be more convenient than pills; the fentanyl patch is

designed to deliver the drug at a steady rate for as long as three

days, so patients don't have to take medication several times a day.

But there are also drawbacks: A single patch contains a

substantially larger quantity of the medication than individual

pills; heat and exercise can increase the rate at which the drug is

absorbed through the skin.

Rappaport said the FDA had not found such serious problems with

other methods of delivering fentanyl, including by injection. " It's

a unique problem with patches because of . . . the way that the drug

is delivered to the body and the way that it's metabolized, " he

said. " It's complicated by the patch formulation. "

The FDA said doctors should not prescribe the patch for patients

whose pain was expected to go away, such as those recovering from an

operation. The patch should be used only by patients who are in

chronic pain and are already safely taking opioid-type drugs.

The agency warned patients to call their doctors if they have

trouble breathing, because fentanyl can shut down the respiratory

system. It said patients wearing the patch should avoid hot showers

and heating pads.

Rappaport said the situation was " very concerning " because such

patch-related deaths could easily be prevented.

And adult patients are not the only ones at risk: At least one child

has died after applying a parent's patch.

Not only is the fentanyl patch strong medicine, it is also widely

used. About 4.7 million prescriptions were filled in 2006, according

to Verispan, a market analysis firm. The patch was introduced in

1990 under the brand name Duragesic by & , but

generic versions by Mylan Inc. and other manufacturers now dominate

the market.

Friday's advisory reinforced an FDA alert in 2005, which all sides

acknowledge did not do enough to reduce the risk to patients. This

time, the agency is directing drug makers to issue brochures that

explain the dangers in plain language.

That was not enough to satisfy safety advocates who have been

tracking problems with the patch for years.

" I think there is more that needs to be done, or else we're just

going to see this [warning] happen again another two years from

now, " said Cohen, president of the Institute for Safe

Medication Practices. " The deaths are going to continue. " The

Pennsylvania group advises hospitals and doctors on how to prevent

medication errors.

Cohen has called on the FDA to limit the number of doctors allowed

to prescribe the drug. That could be done by requiring physicians to

take special instruction in assuring safety.

But the FDA's Rappaport said such restrictions could prevent some

patients who need the medication from getting prescriptions. About

60 million Americans suffer from chronic pain, he said, but only

several thousand doctors in the country are certified pain

specialists.

Nonetheless, Cohen said, he is worried the FDA's latest warning

won't register with busy doctors, particularly those who don't

regularly deal with powerful narcotics. He recommended that

hospitals, which usually have pain experts on staff, require their

specialists to review all prescriptions for the fentanyl patch.

Several deaths reported to his group involved patients

inappropriately prescribed the patch for pain relief after surgery.

Last summer, a study named fentanyl as the second-deadliest drug in

accidental deaths, behind painkiller oxycodone. Analyzing reports to

the FDA from 1998 to 2005, researchers identified 3,545 deaths

linked to fentanyl. The study looked at all forms of fentanyl,

but " the patch was by far the largest contributor, " lead author

J. said in an interview. By comparison, the paper found

that Vioxx -- the painkiller whose 2004 withdrawal was the catalyst

for safety reforms at the FDA -- was a suspect in 932 deaths.

Rappaport said the FDA did not have a definitive count of deaths

caused by the patch and was working to develop one. He suggested the

number could be smaller than reported because many patients using

the patch were severely ill and could have died from underlying

diseases.

Spokesmen for Ortho-McNeil Inc., the subsidiary that makes

Duragesic, and for Mylan said the manufacturers supported the FDA's

action.

Greg Panico of Ortho-McNeil said the company's research indicated

that the safety warnings might be working. Reports of unapproved

uses of Duragesic have declined significantly since the summer of

2006, he said.