Re: Â FDA Panel Urges Ban of Pain Drug

[Guest guest]

Thank you for sharing this Dodge!

I do take Darvocet on a regular basis so hope they don't take it off

the market. My rheum is picky about what meds he will give me anyway.

Debbie L

--- In , Dodge Porter <medicdodge@...>

wrote:

>

>  FDA Panel Urges Ban of Pain Drug

>

> http://www.medicinenet.com/script/main/art.asp?articlekey=97355

>

>

> FDA Panel Urges Ban of Pain Drug

>

> Experts Recommend Stopping Sale of Darvon, Darvocet

>

> By

> Todd Zwillich

> WebMD Health News

>

> Reviewed By

> Louise Chang, MD

>

> Jan. 30, 2009 -- An FDA advisory panel narrowly voted Friday to

recommend that a

> popular pain drug used in dozens of products should be pulled from

the

> market.

>

> The drug, called propoxyphene, has been sold in U.S. pharmacies for

more than 50

> years and today is used in dozens of generic pain medications. Two

brand-name

> versions of the drug, Darvon and Darvocet, are used by millions of

patients

> each year, according to the FDA.

>

> The panel vote was 14-12 in favor of a recommendation to halt sales

of the

> drugs. The FDA officials say it will take them at least several

weeks to decide

> whether to ban propoxyphene from the market.

>

> " It's not a very clear-cut picture, " Sharon Hertz, MD, deputy

director of the

> agency's analgesia drugs division, told reporters. " It's not

straightforward

> that it should or shouldn't come off the market. "

>

> But at the same time, monitoring in Florida and nationally by the

FDA suggests

> the drug may play a role in increasing the risk of suicides and

accidental

> deaths. The agency collected reports of more than 1,400 deaths in

people who had

> taken the drug since 1957, though experts stressed the figure does

not

> prove the drug was the cause of death in all cases.

>

> " I would say, little 'b', big 'r' for this drug. That's little

benefit and lots

> of risk. And that's unsettling, says Ruth Day, PhD, a member of the

panel

> from Duke University who voted to remove the drug.

>

> Most other experts said they thought the risk of a drug containing

propoxyphene

> was probably relatively small. But they also worried that there are

few

> studies showing that it is more effective than other drugs that may

be safer.

>

> Propoxyphene is a narcotic opioid drug. It " looks like it offers

placebo

> benefits with opioid risks, " says Hennessey, PhD, a panel

member and

> epidemiologist

> from the University of Pennsylvania.

>

> But several experts warned that removing Darvon, Darvocet, and other

> propoxyphene-containing drugs could cause disruptions for pain

patients. They

> cautioned it could drive patients to other pain medications like

> OxyContin.

>

> " Every drug you're talking about that's going to deal with pain has

difficulty, "

> says Tinetti, MD, a professor of medicine at Yale

University. " There

> is the possibility that the drugs that would take its place would

cause at least

> as much harm in some people. "

>

> The FDA considered the issue of propoxyphene after the watchdog

group Public

> Citizen petitioned to have the drug removed. The agency initially

did not

> respond,

> and the group sued the government to do a review.

>

> Health authorities in the U.K. ordered a phased removal of

propoxyphene in 2005.

> The drug is now almost completely off the market there.

>

> Sidney Wolfe, MD, director, of Public Citizen's Health Research

Group, presented

> data from the Florida medical examiner blaming 85 deaths on

propoxyphene

> in 2007.

>

> " If that's not a risk, I don't know what is, " Wolfe tells WebMD.

>

> Darvon and Darvocet are sold by Xanodyne Pharmaceuticals Inc.

B. ,

> MD, the company's vice president for clinical development and

medical affairs,

> tells WebMD that the narrow panel vote offers " plenty of room to

have a lot of

> good discussion " with the FDA over whether the drugs should stay on

the

> market.

>

> If FDA keeps the drug on the market, it could require new safety

warnings or

> other restrictions.

>

> " I'm hoping to do everything we can to keep this product available

to the 22

> million people who need it, " says.

>

> Public Citizen first petitioned to have propoxyphene banned in the

1970s.

>

> " It is at least gratifying to see that a majority of people think

this drug

> should come off the market, " Wolfe said after the panel vote.

>

> SOURCES: Sharon Hertz, MD, deputy director, FDA division of

anesthesia,

> analgesia, and rheumatology products. Ruth Day, PhD, Duke

University.

> Hennessey,

> PhD, University of Pennsylvania. Tinetti, MD, professor of

Medicine, Yale

> University. B. , MD, vice president for clinical

development

> and medical affairs, Xanodyne Pharmaceuticals Inc. Sidney Wolfe,

MD, director,

> Public Citizen's Health Research Group.

>

> ©2009 WebMD, LLC. .

> --

>  Dodge

>

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>

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>

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>

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>

[Guest guest]

It’s one of the few pain killers that actually works for me, so I hope they

don’t take it off either.

I’m getting really tired of finding something that works, only to have some

group protest it and pull it from the market.