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FDA warns of deaths from fentanyl patch
San Luis Obispo Tribune ^ | Dec. 21, 2007 | LAURAN NEERGAARD

Posted on 12/21/2007 1:23:43 PM PST by neverdem

AP Medical Writer

WASHINGTON --Improper use of patches that emit the painkiller fentanyl is still killing people, the government said Friday - its second warning in two years about the powerful narcotic.

Some of the deaths came after doctors prescribed the patches to the wrong patients, the Food and Drug Administration said.

The drug is only for chronic pain in people used to narcotics, such as cancer patients, and can cause trouble breathing in people new to this family of "opioid" painkillers. Yet the FDA found cases where doctors prescribed it for headaches or post-surgical pain.

The FDA said patients also accidentally overdose by using the patches wrong, such as putting on more than prescribed, replacing them too frequently or getting them too hot.

"While these products fill an important need, improper use and misuse can be life threatening," said FDA pain chief Dr. Bob Rappaport. "It is crucial that doctors prescribe these products appropriately, and that patients use them correctly."

The FDA first warned about improper patch use in 2005, when it announced it was investigating 120 deaths.

Although FDA has investigated the new reports for several months, Rappaport refused to say Friday how many additional deaths the agency has learned of since that first warning.

He called the number of reports small but concerning because "they are preventable."

Friday, the FDA said it had ordered patch makers to create special medication guides that will come with every box, spelling out proper use in easy-to-understand language.

What kind of mistakes are happening?

The consumer advocacy Institute for Safe Medication Practices highlighted some cases last summer. One patient died after being given a patch for post-surgery pain despite having pneumonia and being new to narcotics. Two others survived, an elderly man taken to the emergency room after being given a patch together with painkilling pills and an elderly woman who became delirious while wearing several patches at once.

The FDA's main message Friday: Do not prescribe fentanyl patches to anyone new to opioids, the painkiller family that includes morphine. Absorbing fentanyl through the skin is a powerful way to deliver the potent drug, and thus poses serious risk to anyone not already opioid-tolerant, Rappaport explained.

Doctors who aren't specially trained in pain management may not know that. But Rappaport said FDA isn't considering curbs on prescribing because there is a great need for the patches among the millions of chronic pain sufferers, few of whom get care from pain specialists.

Among the warnings:

-Fentanyl patches can cause severe trouble breathing. Get emergency help if you have trouble breathing or extreme drowsiness with slowed breathing; feel faint, dizzy, confused; or have other unusual symptoms. They can be signs that you were prescribed too high a dose or took too much.

-Fentanyl patches are only for round-the-clock pain that is moderate to severe and expected to last for weeks. They are not for sudden, occasional or mild pain, or pain after surgery.

-The patches should not be your first narcotic painkiller.

-Ask your doctor how often to apply the patch, whether to reapply one that has fallen off and how to replace it. Doing any of that wrong can cause an accidental overdose.

-Do not use heating pads, electric blankets, saunas or heated waterbeds, take very hot baths or sunbathe while wearing a fentanyl patch. Heat may increase the drug's absorption, causing a life-threatening overdose. Call a doctor right away if body temperature becomes higher than 102 degrees while wearing a patch.

The patches were first approved under the brand name Duragesic in 1990, but generic versions are sold by other manufacturers.


TOPICS: Health/Medicine
KEYWORDS: drugabuse; fda; fentanyl; government; health; medicine; overdose; painmanagement; prescriptionabuse

1 posted on 12/21/2007 1:23:46 PM PST by neverdem
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To: neverdem

This is why I use one pharmacy for all prescriptions. My pharmacist knows a whole lot more about drugs and their uses as well as contraindications, than my doctor.


2 posted on 12/21/2007 3:29:17 PM PST by Not gonna take it anymore
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To: DAVEY CROCKETT; Calpernia; Velveeta; LibertyRocks; Founding Father; milford421

Ping.


3 posted on 12/21/2007 3:59:27 PM PST by nw_arizona_granny (I vote to outlaw hidden links in articles. If the URL is worthy of clicking, then show it.)
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To: nw_arizona_granny

Thanks, I just forwarded to someone that I know that uses these.


4 posted on 12/21/2007 4:28:18 PM PST by Calpernia (Hunters Rangers - Raising the Bar of Integrity http://www.barofintegrity.us)
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To: Calpernia

I am glad it was useful info.

The name is so close to the gas that was used in the Nord Ost theater in Russia, by Putin, that killed so many of the hostages.

I could ask Struwwelpeter, but he is so busy these days, now that he is back in uniform, he does not have time for old news.


5 posted on 12/21/2007 4:35:48 PM PST by nw_arizona_granny (I vote to outlaw hidden links in articles. If the URL is worthy of clicking, then show it.)
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To: nw_arizona_granny

The name is so close to the gas that was used in the Nord Ost theater in Russia, by Putin, that killed so many of the hostages.

Same stuff.

People eat the patch in suicide attempts.


6 posted on 12/21/2007 5:49:48 PM PST by Chickensoup (If it is not permitted, it is prohibited. Only the government can permit....)
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To: neverdem

Dang. No more patch parties, I guess.


7 posted on 12/21/2007 5:50:39 PM PST by Jeff Chandler ("Liberals want to save the world for the children they aren't having." -Mark Steyn)
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To: El Gato; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; jb6; tiamat; PGalt; Dianna; ...
Government warnings about fatal overdoses should be chat according to the admin mods. Don't you agree?

Congress bans incandescent bulbs

Astronomers Monitor Asteroid To Pass Near Mars

FReepmail me if you want on or off my health and science ping list.

8 posted on 12/21/2007 10:18:14 PM PST by neverdem (Call talk radio. We need a Constitutional Amendment for Congressional term limits. Let's Roll!)
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To: Not gonna take it anymore

if you don’t trust your doctor, you should get a new one....


9 posted on 12/21/2007 10:54:47 PM PST by cherry
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To: Not gonna take it anymore
we are a drug addicted society....we run to the doctor for colss, "sinus infections", constipation, a sore back, etc... we want relief and we want pills ( not me)

why am I not surprised that doctors are prescribing these patches to the wrong people...

10 posted on 12/21/2007 10:57:36 PM PST by cherry
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To: Chickensoup

Thanks for knowing the names were the same.

I never trust my memory of chemical names.

I thought Struwwelpeter said it was for use on animals.


11 posted on 12/22/2007 12:56:17 AM PST by nw_arizona_granny (I vote to outlaw hidden links in articles. If the URL is worthy of clicking, then show it.)
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To: cherry
why am I not surprised that doctors are prescribing these patches to the wrong people...

I agree strongly with you about the overuse of medication in our society.

But the article (and press release) is long on accusation, short on those devilish details, it seems to me. Sort of like reading an indictment where a defendant is accused of everything, including smoking and voting for Richard Nixon.

We don't know the details of the case where a patch was prescribed for a headache. We don't know what else had been tried, the dose and length of therapy, how excruciating the pain was. It may have been--probably was--justified in a humanitarian sense. Docs don't just go prescribing these things on whims.

And the deaths: sure, there are some iatrogenic deaths, as there with all drugs with dangerous therapeutic indices. But I'll wager that when the facts are known, and the FDA's press release has served its purpose, we'll find that most were from addicts withdrawing the substance from the patch and injecting it. Sorry, but that's a yawner, because it's not news. It's been happening for years.

This looks like the first salvo in a war on fentanyl, just like they did with oxycontin.

12 posted on 12/22/2007 5:43:31 AM PST by jammer
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