Re: FDA approves fibromyalgia drug

[Guest guest]

I will be most interested in the scientificly minded folks' reaction

to this article on Lyrica for fms. My latest fiasco of treatment for

my head pressure was a neuro who decided I have tension headaches. He

prescribed, guess what, Lyrica. I read that when you stop it

intracranial pressure will increase. Also, if you note one side

effect seems to be fluid retention and weight gain. IF indeed I have

intracranial hypertension I cannot imagine a WORSE DRUG TO TAKE.

(Needless to say, I did not take this drug which is very expensive

even with health insurance.) Furthermore, I cannot see where it fixes

the underlying cause of anything. Am I missing something?

Thanks for any replies,

a

>

> Well, I guess at least it's good to know that FMS is starting to be

taken seriously as a real illness, even if they don't know what it is.

>

> http://online.wsj.com/article/SB118245956340043894.html?

mod=googlenews_wsj

>

> FDA Approves Pfizer's Lyrica

> For Treatment of Fibromyalgia By JENNIFER CORBETT DOOREN

> June 21, 2007 5:16 p.m.

>

> WASHINGTON -- The U.S. Food and Drug Administration on Thursday

approved Pfizer Inc.'s Lyrica to treat fibromyalgia, a poorly

understood pain disorder.

> The approval marks the first time a drug has been approved for

fibromyalgia, which is believed to affect three to six million

Americans, mostly women. Fibromyalgia is marked by widespread muscle

pain, tenderness and fatigue. The condition traditionally has been

treated with a mix of painkillers and antidepressants.

> Lyrica, already on the market to treat nerve pain associated with

diabetes and shingles, is designed to interfere with damaged nerves

that cause pain. The drug had $1.2 billion in world-wide sales last

year, and has been used by about five million people.

> The FDA granted Lyrica priority review status, which cuts four

months off the standard 10-month drug review time and is reserved for

treatments the agency deems an advance over existing therapies on the

market.

> The approval was good news for Pfizer, which on Wednesday saw the

FDA delay approval of its proposed HIV drug maraviroc. Pfizer also

announced Wednesday it had ended development of a lung cancer

compound, PF-3512676 for lack of effectiveness.

> Romano, a vice president in Pfizer's global medical

division, said Lyrica appears to " dampen " the hyperexcitability of

the central nervous system.

> The FDA said Lyrica reduces pain and improves daily functions for

some patients with fibromyalgia.

> " Today's new approval marks an important advance, and provides a

reason for optimism for the many patients who will receive pain

relief with Lyrica, " said Galson, the director of FDA's Center

for Drug Evaluation and Research. However, he cautioned that not

everyone on the clinical studies experience a benefit from Lyrica.

> The FDA said two studies involving about 1,800 patients, support

approval for use in treating fibromyalgia with doses of 300

milligrams or 450 milligrams per day. Pfizer had also studied a

higher 600-milligram dose for Lyrica.

> One of the studies involving Lyrica lasted about three months and

involved about 750 patients who were assigned to a 600-milligram, 450-

milligram or 300-milligram dose of Lyrica or a placebo. It showed

that 30% of patients on the highest dose had a 50% or more reduction

in pain, as measured by a commonly used index, compared with 27% on

the middle dose, 24% at the lowest dose and 15% on placebo, or a fake

pill.

> The most common side effects of Lyrica included dizziness and

sleepiness. Blurred vision, weight gain, dry mouth, and swelling of

the hands and feet also were reported in clinical trials, and the FDA

said side effects appeared to be dose related.

> The FDA said Pfizer has agreed to study Lyrica in children with

fibromyalgia as well as a study in breastfeeding women.

> Write to Corbett Dooren at jennifer.corbett-dooren@...

>

[Guest guest]

I know what you mean. The tests results didn't look

that positive and the side affects sound worse than

the symptoms.

Marie

--- pjeanneus <pj7@...> wrote:

> I will be most interested in the scientificly minded

> folks' reaction

> to this article on Lyrica for fms. My latest fiasco

> of treatment for

> my head pressure was a neuro who decided I have

> tension headaches. He

> prescribed, guess what, Lyrica. I read that when you

> stop it

> intracranial pressure will increase. Also, if you

> note one side

> effect seems to be fluid retention and weight gain.

> IF indeed I have

> intracranial hypertension I cannot imagine a WORSE

> DRUG TO TAKE.

> (Needless to say, I did not take this drug which is

> very expensive

> even with health insurance.) Furthermore, I cannot

> see where it fixes

> the underlying cause of anything. Am I missing

> something?

>

> Thanks for any replies,

> a

>

>

> >

> > Well, I guess at least it's good to know that FMS

> is starting to be

> taken seriously as a real illness, even if they

> don't know what it is.

> >

> >

>

http://online.wsj.com/article/SB118245956340043894.html?

> mod=googlenews_wsj

> >

> > FDA Approves Pfizer's Lyrica

> > For Treatment of Fibromyalgia By JENNIFER CORBETT

> DOOREN

> > June 21, 2007 5:16 p.m.

> >

> > WASHINGTON -- The U.S. Food and Drug

> Administration on Thursday

> approved Pfizer Inc.'s Lyrica to treat fibromyalgia,

> a poorly

> understood pain disorder.

> > The approval marks the first time a drug has

> been approved for

> fibromyalgia, which is believed to affect three to

> six million

> Americans, mostly women. Fibromyalgia is marked by

> widespread muscle

> pain, tenderness and fatigue. The condition

> traditionally has been

> treated with a mix of painkillers and

> antidepressants.

> > Lyrica, already on the market to treat nerve

> pain associated with

> diabetes and shingles, is designed to interfere with

> damaged nerves

> that cause pain. The drug had $1.2 billion in

> world-wide sales last

> year, and has been used by about five million

> people.

> > The FDA granted Lyrica priority review status,

> which cuts four

> months off the standard 10-month drug review time

> and is reserved for

> treatments the agency deems an advance over existing

> therapies on the

> market.

> > The approval was good news for Pfizer, which on

> Wednesday saw the

> FDA delay approval of its proposed HIV drug

> maraviroc. Pfizer also

> announced Wednesday it had ended development of a

> lung cancer

> compound, PF-3512676 for lack of effectiveness.

> > Romano, a vice president in Pfizer's

> global medical

> division, said Lyrica appears to " dampen " the

> hyperexcitability of

> the central nervous system.

> > The FDA said Lyrica reduces pain and improves

> daily functions for

> some patients with fibromyalgia.

> > " Today's new approval marks an important

> advance, and provides a

> reason for optimism for the many patients who will

> receive pain

> relief with Lyrica, " said Galson, the

> director of FDA's Center

> for Drug Evaluation and Research. However, he

> cautioned that not

> everyone on the clinical studies experience a

> benefit from Lyrica.

> > The FDA said two studies involving about 1,800

> patients, support

> approval for use in treating fibromyalgia with doses

> of 300

> milligrams or 450 milligrams per day. Pfizer had

> also studied a

> higher 600-milligram dose for Lyrica.

> > One of the studies involving Lyrica lasted about

> three months and

> involved about 750 patients who were assigned to a

> 600-milligram, 450-

> milligram or 300-milligram dose of Lyrica or a

> placebo. It showed

> that 30% of patients on the highest dose had a 50%

> or more reduction

> in pain, as measured by a commonly used index,

> compared with 27% on

> the middle dose, 24% at the lowest dose and 15% on

> placebo, or a fake

> pill.

> > The most common side effects of Lyrica included

> dizziness and

> sleepiness. Blurred vision, weight gain, dry mouth,

> and swelling of

> the hands and feet also were reported in clinical

> trials, and the FDA

> said side effects appeared to be dose related.

> > The FDA said Pfizer has agreed to study Lyrica

> in children with

> fibromyalgia as well as a study in breastfeeding

> women.

> > Write to Corbett Dooren at

> jennifer.corbett-dooren@...

> >

>

>

>

________________________________________________________________________________\

____

Choose the right car based on your needs. Check out Autos new Car Finder

tool.

http://autos./carfinder/

[Guest guest]

a

Just a fleeting thought. You have to take a step back and start

again.We informed you to make sure your scans are worth doing.there's

a doctor in phoenix that MAY have lit up some of your problems with

the right type of technology.You ended up goimng around the mill for

thw whole year and we sort of knew, as has happened to many of our

friends before you, that you were barking up the wrong tree. The best

and funniest part is the way one so called expert ditches what

another so called expert diagnoses.How dangerous are these people at

the top with no-one looking down on them.

>

> I will be most interested in the scientificly minded folks'

reaction

> to this article on Lyrica for fms. My latest fiasco of treatment

for

> my head pressure was a neuro who decided I have tension headaches.

He

> prescribed, guess what, Lyrica. I read that when you stop it

> intracranial pressure will increase. Also, if you note one side

> effect seems to be fluid retention and weight gain. IF indeed I

have

> intracranial hypertension I cannot imagine a WORSE DRUG TO TAKE.

> (Needless to say, I did not take this drug which is very expensive

> even with health insurance.) Furthermore, I cannot see where it

fixes

> the underlying cause of anything. Am I missing something?

>

> Thanks for any replies,

> a

>

>

> >

> > Well, I guess at least it's good to know that FMS is starting to

be

> taken seriously as a real illness, even if they don't know what it

is.

> >

> > http://online.wsj.com/article/SB118245956340043894.html?

> mod=googlenews_wsj

> >

> > FDA Approves Pfizer's Lyrica

> > For Treatment of Fibromyalgia By JENNIFER CORBETT DOOREN

> > June 21, 2007 5:16 p.m.

> >

> > WASHINGTON -- The U.S. Food and Drug Administration on Thursday

> approved Pfizer Inc.'s Lyrica to treat fibromyalgia, a poorly

> understood pain disorder.

> > The approval marks the first time a drug has been approved for

> fibromyalgia, which is believed to affect three to six million

> Americans, mostly women. Fibromyalgia is marked by widespread

muscle

> pain, tenderness and fatigue. The condition traditionally has been

> treated with a mix of painkillers and antidepressants.

> > Lyrica, already on the market to treat nerve pain associated

with

> diabetes and shingles, is designed to interfere with damaged nerves

> that cause pain. The drug had $1.2 billion in world-wide sales last

> year, and has been used by about five million people.

> > The FDA granted Lyrica priority review status, which cuts four

> months off the standard 10-month drug review time and is reserved

for

> treatments the agency deems an advance over existing therapies on

the

> market.

> > The approval was good news for Pfizer, which on Wednesday saw

the

> FDA delay approval of its proposed HIV drug maraviroc. Pfizer also

> announced Wednesday it had ended development of a lung cancer

> compound, PF-3512676 for lack of effectiveness.

> > Romano, a vice president in Pfizer's global medical

> division, said Lyrica appears to " dampen " the hyperexcitability of

> the central nervous system.

> > The FDA said Lyrica reduces pain and improves daily functions

for

> some patients with fibromyalgia.

> > " Today's new approval marks an important advance, and provides

a

> reason for optimism for the many patients who will receive pain

> relief with Lyrica, " said Galson, the director of FDA's

Center

> for Drug Evaluation and Research. However, he cautioned that not

> everyone on the clinical studies experience a benefit from Lyrica.

> > The FDA said two studies involving about 1,800 patients,

support

> approval for use in treating fibromyalgia with doses of 300

> milligrams or 450 milligrams per day. Pfizer had also studied a

> higher 600-milligram dose for Lyrica.

> > One of the studies involving Lyrica lasted about three months

and

> involved about 750 patients who were assigned to a 600-milligram,

450-

> milligram or 300-milligram dose of Lyrica or a placebo. It showed

> that 30% of patients on the highest dose had a 50% or more

reduction

> in pain, as measured by a commonly used index, compared with 27% on

> the middle dose, 24% at the lowest dose and 15% on placebo, or a

fake

> pill.

> > The most common side effects of Lyrica included dizziness and

> sleepiness. Blurred vision, weight gain, dry mouth, and swelling of

> the hands and feet also were reported in clinical trials, and the

FDA

> said side effects appeared to be dose related.

> > The FDA said Pfizer has agreed to study Lyrica in children with

> fibromyalgia as well as a study in breastfeeding women.

> > Write to Corbett Dooren at jennifer.corbett-dooren@

> >

>

[Guest guest]

Sounds like it is another in the line of gabapentin. That certainly

doesn't prove that it's a " file under gabapentin " drug, but it

probably is.

> I will be most interested in the scientificly minded folks'

reaction

> to this article on Lyrica for fms. My latest fiasco of treatment

for

> my head pressure was a neuro who decided I have tension headaches.

He

> prescribed, guess what, Lyrica. I read that when you stop it

> intracranial pressure will increase. Also, if you note one side

> effect seems to be fluid retention and weight gain. IF indeed I

have

> intracranial hypertension I cannot imagine a WORSE DRUG TO TAKE.

> (Needless to say, I did not take this drug which is very expensive

> even with health insurance.) Furthermore, I cannot see where it

fixes

> the underlying cause of anything. Am I missing something?

>

> Thanks for any replies,

> a

>