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Topic: What is Taurine? Can I OD on Imitrex??? (Read 737 times) |
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Jellyneen
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What is Taurine? Can I OD on Imitrex???
« on: Oct 29th, 2006, 6:33pm » |
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Can someone please tell me what Taurine is?? Im a little confused, is it in Red Bull or Chinese food???
And Imitrex is my only saving grace and I use it constantly. I know you are only suppossed to take 12mg a day, but that for me is impossible. Anyone take more than that??? Can I overdose from this stuff??
And one last question... What level am I supposed to set my oxygen level at? I have read 15ml's but my tanks only go up to 8... What am I missing??
Thanks and hope you all have pain free days and nights!!
Janeen
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| « Last Edit: Oct 29th, 2006, 6:42pm by Jellyneen » |
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E-Double
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #1 on: Oct 29th, 2006, 7:24pm » |
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on Oct 29th, 2006, 6:33pm, Jellyneen wrote:Can someone please tell me what Taurine is?? Im a little confused, is it in Red Bull or Chinese food???
And Imitrex is my only saving grace and I use it constantly. I know you are only suppossed to take 12mg a day, but that for me is impossible. Anyone take more than that??? Can I overdose from this stuff??
24 is the suggestion. Many do but many split. If you use the injections, split them and you will get more jabs 4 your buck
And one last question... What level am I supposed to set my oxygen level at? I have read 15ml's but my tanks only go up to 8... What am I missing??
A regulator that goes to 15. Some have luck with less but many are more successful with higher. Yo u also need the right type of mask
Thanks and hope you all have pain free days and nights!!
Janeen |
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BB
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #3 on: Oct 29th, 2006, 9:47pm » |
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You dont OD on Imitrex but too much of it is bad for your heart long term and they can cause rebound headaches ie, increases the number of attacks.
Best to stick to 12 mg per day and split the dose.
If you use the injection look at the Imitrex tip on the left side of the Board for instruction how on to split them.
Take care
Annette
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Pinkfloyd
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #4 on: Oct 30th, 2006, 3:07am » |
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on Oct 29th, 2006, 9:47pm, BB wrote:
You dont OD on Imitrex but too much of it is bad for your heart long term and they can cause rebound headaches ie, increases the number of attacks.
Annette |
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??????????? So what? 48mg/day? 96mg??
People can and do, OD on aspirin. 
If you think OD only means Death.....it doesn't, but there have been enough deaths associated with Imitrex that even with that definition, it should meet your guidelines. It's also not just a matter of long term usage problems. Tell that to the people that died from the first shot.
Janeen,
I honestly don't mean to scare you but I think you should know the truth about Imitrex and its possible side effects.
Yes, many people use much more than the manufacturer recommends, and millions of people use it without any problems...but, again, you should know what the truth is so if you notice any symptoms, you'll know whats going on.
Please go here...
http://www.rxlist.com/cgi/generic/sumatsub.htm
and click on all the top tabs, including the ones marked, side effects and contraindications and.....overdose.
Bobw
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BB
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #5 on: Oct 30th, 2006, 5:13am » |
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Copied from the link you provided, Pinkfloyd
OVERDOSE
Patients (N = 269) have received single injections of 8 to 12 mg without significant adverse effects. Volunteers (N = 47) have received single subcutaneous doses of up to 16 mg without serious adverse events.
No gross overdoses in clinical practice have been reported. Coronary vasospasm was observed after intravenous administration of IMITREX Injection (see CONTRAINDICATIONS).
Overdoses would be expected from animal data (dogs at 0.1 g/kg, rats at 2 g/kg) to possibly cause convulsions, tremor, inactivity, erythema of the extremities, reduced respiratory rate, cyanosis, ataxia, mydriasis, injection site reactions (desquamation, hair loss, and scab formation), and paralysis. The half-life of elimination of sumatriptan is about 2 hours (see CLINICAL PHARMACOLOGY: Pharmacokinetics), and therefore monitoring of patients after overdose with IMITREX Injection should continue while symptoms or signs persist, and for at least 10 hours.
It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.
CONTRAINDICATIONS
IMITREX Injection should not be given intravenously because of its potential to cause coronary vasospasm.
IMITREX Injection should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive IMITREX Injection. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort and vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease (see WARNINGS: Other Vasospasm-Related Events and WARNINGS: Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events).
Because IMITREX Injection may increase blood pressure, it should not be given to patients with uncontrolled hypertension. IMITREX Injection and any ergotamine-containing or ergot-type medication (like dihydroergotamine or methysergide) should not be used within 24 hours of each other, nor should IMITREX Injection and another 5-HT1 agonist.
IMITREX Injection should not be administered to patients with hemiplegic or basilar migraine.
IMITREX Injection is contraindicated in patients with hypersensitivity to sumatriptan or any of its components.
IMITREX Injection is contraindicated in patients with severe hepatic impairment.
According to the Australian Pharmaceutical Board , there has been no dangerous overdose reported, at least in Australia.
Where did you get the information that people dies from the first dose taken ? I would like to know that very much please. Thank you.
Also Glaxo and Astra are applying for both Imitrex and Zomig to be released from prescription drugs only to be Pharmeceutical drugs, if approved, that means you can buy both at a chemist without prescriptions. If they ( the companies ) are not confident of the safety profile of the drugs, they would never go down this path.
Regarding overdosing on Aspirin, of course one can overdose on anything if one is silly enough to ignore medical warnings and take a ridiculously high amount. With triptans though, the chest pain one gets very quickly as side effects would likely stop you from going too far with it.
I know of people who takes 8 Trex injections per day without much short term problems apart from rebounds , although generally thats not recommended.
As I said before, best to stick to 12mg per day.
Annette
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Pinkfloyd
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #6 on: Oct 30th, 2006, 9:21pm » |
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on Oct 30th, 2006, 5:13am, BB wrote:
Where did you get the information that people dies from the first dose taken ? I would like to know that very much please. Thank you.
See below
Also Glaxo and Astra are applying for both Imitrex and Zomig to be released from prescription drugs only to be Pharmeceutical drugs, if approved, that means you can buy both at a chemist without prescriptions.
Same in the UK
If they ( the companies ) are not confident of the safety profile of the drugs, they would never go down this path.
See below. You are kidding aren't you? This has nothing to do with safety. It has only to do with profit vs. cost of lawsuits.
Regarding overdosing on Aspirin, of course one can overdose on anything if one is silly enough to ignore medical warnings and take a ridiculously high amount.
Like ignore the recommended 12mg and use 8 shots a day? Who'd be "silly" enough to do that?
With triptans though, the chest pain one gets very quickly as side effects would likely stop you from going too far with it.
really?
I know of people who takes 8 Trex injections per day without much short term problems apart from rebounds , although generally thats not recommended.
generally?
As I said before, best to stick to 12mg per day.
Annette
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See below....the answers to your other questions will take up some space....more than will fit on one post.
Bobw
to be continued....
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purpleydog
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #7 on: Oct 30th, 2006, 9:26pm » |
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on Oct 30th, 2006, 5:13am, BB wrote:
According to the Australian Pharmaceutical Board , there has been no dangerous overdose reported, at least in Australia.
Where did you get the information that people dies from the first dose taken ? I would like to know that very much please. Thank you.
Also Glaxo and Astra are applying for both Imitrex and Zomig to be released from prescription drugs only to be Pharmeceutical drugs, if approved, that means you can buy both at a chemist without prescriptions.
Regarding overdosing on Aspirin, of course one can overdose on anything if one is silly enough to ignore medical warnings and take a ridiculously high amount. With triptans though, the chest pain one gets very quickly as side effects would likely stop you from going too far with it.
I know of people who takes 8 Trex injections per day without much short term problems apart from rebounds , although generally thats not recommended.
As I said before, best to stick to 12mg per day.
Annette
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Annette,
There may not have been any reported dangerous overdoses of Imitrex in Australia, but what makes it dangerous? An overdoes is an overdose, and that is the question at hand.
I can tell you that when the clinical trials were underway in the United States for Imitrex, back in the early 90's, at least one person died when they were given an injection of Imitrex, and that person did not have a pre-existing heart condition of any kind. The FDA stopped the trials, and it was awhile before they would let it resume again, while all of the research was gone over to see if they, the drug developers, had missed anything. It was then determined that having a heart condition was a contraindication to using trex.
As far as Glaxo, applying to be released from prescription, in the United States, Glaxo is doing anything and everything they can for Imitrex to NOT be released to a generic drug manufacturer, so they can still make money from it. In the USA, a drug company holds the patent on a drug for 17 years, then it can be made by a generic drug company, where it can be prescribed by a doctor, and the patient can pay much less for it. That is the last thing the drug companies want.
Interesting, yes of course one can overdose on aspirin, one can overdose on anything, and it doesn't have to be a ridiculously high amount, nor do medical warnings need to be ignored. What if medical warnings are not given? Nothing silly about that. And a member here just recently passed away from an overdose on a Fentanyl patch. One patch. I don't find that to be a ridiculously high amount of medicine. Of course, I'm not a doctor, and I didn't examine this person, nor do I know his history, so I can't really say. Everyone has their limits, and everyone reacts differently to meds.
What is important when people are taking medicine, is that they are under a doctor's supervision, and the doctor and the patient agree to a plan to treat the patient. If that means taking trex whenever needed then that is between the patient and the doc.
Please be careful of recommending medication of any kind to anyone. It would be irresponsible of a doctor to dispense medical advice over the internet, or in any other forum without knowing the person, or examining him or her first. Not to mention opening themselves up to all kinds of lawsuits.
These people that you know that take 8 shots of trex a day... are they patients of yours? Are you prescribing their imitrex?
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Pinkfloyd
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #8 on: Oct 30th, 2006, 9:27pm » |
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Again, before everyone starts lambasting me for pointing out the facts on Imitrex.....I'm not suggesting people stop using it. I'm NOT trying to scare anyone. If it works for you...great.
A little history lesson in Imitrex.
J Headache Pain. 2006 Jun 15; [Epub ahead of print] Related Articles, Links
Spontaneous splenic infarction associated with sumatriptan use.
Arora A, Arora S.
Department of Internal Medicine, Western Pennsylvania Hospital Temple University Program, 4800 Friendship Avenue, Pittsburgh, PA 15224, USA, anjuarora27@hotmail.com.
Triptans are specific agonists of the serotonergic 5-HT(1B/1D) receptors that have increasingly been used in the treatment of migraine and cluster headaches. Though they are generally considered safe, there have been a few reports of myocardial infarction and stroke associated with triptan use. We report a patient who developed spontaneous splenic infarction after the use of sumatriptan for the treatment of migraine headache.
PMID: 16767537 [PubMed - as supplied by publisher]
By Nicholas Regush
September/October 1995 Issue (Mother Jones)
On the morning of Feb. 4, 1994, Dianne Riley joked nervously with her
husband and one of her four children about a dream she'd had the night
before in which someone had died. This wasn't a pleasant way to begin
the day, because once before Riley had actually forecast a death in
this manner.
To make matters worse, Riley had a miserable headache. For five days
running, the 41-year-old assistant manager for a Ramada Inn in Kansas
City, Mo., had felt the pain in her head build to the point where she
would be overpowered by nausea.
Later that morning, Riley had an appointment with Dr. Samuel Ho, a
specialist in internal medicine. He diagnosed migraine, a slowly
developing headache with throbbing pain that is usually felt on only
one side of the head. The condition is believed to affect between 15
and 25 million Americans, mostly women.
Ho recommended Riley try Imitrex, the brand name for sumatriptan
succinate, a heavily marketed new drug for migraines. At 12:25 p.m.,
Riley was given a six-milligram injection of the drug. Within minutes,
she began to sweat, vomit, and experience chest pains.
Technicians managed to hook her up to an electrocardiograph and
quickly discovered that she had an abnormal heart rhythm. They called
911.
An emergency team reached Ho's clinic at 12:56 p.m., and transported
Riley to St. Luke's Northland Hospital where she arrived with
resuscitation efforts in progress. At 1:58 p.m., a doctor pronounced
Riley dead. An autopsy performed the
next day indicates Riley's cause of death was "a result of adverse
effect of Imitrex."
On April 15, two months after Dianne Riley's death, her family filed a
lawsuit in the Circuit Court of Jackson County, Mo., charging that
Glaxo, the British-based manufacturer of Imitrex, had been aware that
the drug could cause serious harm or even death. The lawsuit accuses
the multinational and its Cerenex division in North Carolina of not
adequately labeling Imitrex and not disclosing the drug's true risks,
"in order to collect substantially higher profits." Glaxo will not
comment on the lawsuit because it is under litigation. The case, still
in the legal discovery phase, is expected to go to trial sometime in
1996.
Dr. Vincent Di Maio, one of the country's leading forensic
pathologists and editor of the American Journal of Forensic Medicine
and Pathology, intends to testify on the Rileys' behalf. He says he
has examined all the microscopic slides of tissues and organs from the
Riley autopsy and has no doubt that its conclusion was correct.
Although Dianne Riley had some risk factors for heart disease (e.g.,
smoking, family history of heart disease), Di Maio says her heart and
coronary arteries were healthy; the heart attack that killed her was
precipitated by Imitrex.
"It is a very complete autopsy," Di Maio says. "This is a simple case
where a young woman took Imitrex, started to react to it badly,
developed an irregular heartbeat, and died. The autopsy shows clearly
that there was no evidence of hardening of her arteries, no evidence
of infection, no evidence of an enlarged heart, no evidence of stroke,
no evidence of meningitis or encephalitis, no evidence of a blood
clot, no evidence of lung disease, no evidence of asthma or allergic
reaction, no evidence whatsoever of disease. If there is no other
cause of death, by deductive reasoning she died of a coronary
vasospasm following the use of Imitrex."
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Pinkfloyd
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #9 on: Oct 30th, 2006, 9:32pm » |
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Imitrex, a top-line Glaxo drug, is used by more than two million
people worldwide. The drug's sales in fiscal year 1993-94 were $365
million. Both of those numbers are likely to increase when the tablet
version of the drug becomes available on the U.S. prescription market
this month.
To date, the Food and Drug Administration has received 3,526 voluntary
reports of possible side effects, ranging from mild to severe,
associated with the use of Imitrex. Included are reports of 83 deaths
and at least 273 life-threatening complications.
Earlier this year, Glaxo became the world's largest pharmaceutical
company when it bought Wellcome, another British multinational. Glaxo
and Wellcome sold a combined $11.6 billion worth of products last
year, to fight everything from asthma and ulcers to heart disorders,
infections, and migraines.
In the high-stakes pursuit of competitive advantage, drug giants like
Glaxo must sometimes spend hundreds of millions of dollars to develop
new drugs. To see returns on these investments, companies push hard to
get the drugs through the regulatory approval process and promote them
vigorously when they are first released. Glaxo's push of Imitrex was
no exception.
The history of Imitrex goes all the way back to 1972, when Glaxo
launched a research program to develop a new migraine drug. The
company's goal was to find a chemical that could narrow swollen blood
vessels in the head, thereby stopping the pain of migraine headaches.
But it was also important that the drug not narrow or squeeze blood
vessels in the heart, because this could cause spasm in those vessels
and trigger a heart attack.
More than a decade passed before Glaxo scientists came up with
Imitrex. The drug mimicked serotonin, a chemical produced naturally in
the body. Serotonin contracts blood vessels by acting on their cells
via the gateways or "receptors" known as 5HT. Glaxo researchers
thought that Imitrex would affect only the type of 5HT receptor known
as 5HT-1, which they believed was rarely found in heart vessels, and
therefore the drug would not cause heart spasm.
Glaxo believed it had a blockbuster drug in the making, one with a
potential market of hundreds of millions of dollars.
Looking back, however, some fundamental research data contradicted the
presumption that 5HT-1 receptors were generally absent from heart
vessels. In one small laboratory study, Glaxo researchers found that
Imitrex caused small contractions in coronary artery samples from
explanted human hearts, indicating the presence of 5HT-1 receptors in
heart vessels. An independent study also supported this hypothesis by
demonstrating that Imitrex could cause temporary narrowing in the
coronary arteries of patients with or without signs of heart disease.
Glaxo, however, emphasized other research that supported Imitrex's
safety. Specifically, one Glaxo study showed that Imitrex did not
affect the cardiovascular systems of dogs, indicating that 5HT-1
receptors were not present in the dogs' heart vessels and suggesting
that this might be true for human beings as well. The company also
assured regulatory agencies that the drug was safe because its
heart-monitoring tests during clinical trials showed that very few
patients suffered heart disturbances.
Strong indications that these assurances were hollow first surfaced in
Canada.
On Dec. 20, 1991, Dr. Michele Brill-Edwards, then the assistant
director of the Bureau of Human Prescription Drugs at Health and
Welfare Canada, wrote a memo to the bureau's assistant director of
operations, Peter Jeffs, expressing her suspicion that Glaxo was
pressuring one of her reviewers to move faster on getting approval for
Imitrex.
After Brill-Edwards reviewed the file herself, she believed that there
were potential problems with Imitrex. She was particularly concerned
that Glaxo had only thin documentation to show that Imitrex was not a
danger to heart vessels.
Brill-Edwards also wondered about Imitrex's recommended dosage of six
milligrams. Glaxo studies had shown that a one-milligram dose was
enough for some patients and three milligrams worked for up to 60
percent of patients. Only an additional 10 to 20 percent benefited
from the six-milligram dose. Yet contrary to standard medical
practice, which recommends tailoring dosage to a patient's needs,
Glaxo recommended six milligrams for everyone. (A Glaxo spokesperson
told Mother Jones that the company chose the six-milligram dose as
"the best balance between efficacy and safety."
For more than two weeks, Brill-Edwards (who is under orders not to
discuss Imitrex with the media) raised concerns within her bureau
about Imitrex's safety, and questioned Glaxo's efforts to expedite the
drug's approval.
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Pinkfloyd
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #10 on: Oct 30th, 2006, 9:33pm » |
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In a Jan. 7, 1992 memo, she described the situation
to her boss, Dr. Claire Franklin, then the director of the Bureau of
Human Prescription Drugs:
At 5:15 p.m. [Jan. 6], Ms. Gita Lingam, [then the] head of regulatory
affairs for Glaxo, telephoned.a Threatening remarks were made
courteously. Ms. Lingam noted that Mr. Randall Chase [then a senior vice president of Glaxo Canada] intends to take the matter "to a
higher level" if there are further delays. Legal action was
intimated.a
[T]he product monograph remains less than adequate in its
characterization of safe usage of this valuable new product. My
recommendation is that the clinical division should be required to
remedy the deficiencies in the product monograph.--This action should
be undertaken notwithstanding substantial pressure to the contrary
from the manufacturer.
The deficiencies in the monograph were not remedied. On Jan. 16, 1992,
nine days after Brill-Edwards wrote her memo, Glaxo announced that it
would construct a $70 million manufacturing facility in Canada,
promising more jobs and research spending.
Four days later, on Jan. 20, senior managers at Health and Welfare
Canada approved Imitrex.
The next month, when Glaxo launched its promotional campaign for
Imitrex in Canada, it claimed the drug "works only on the painfully
swollen blood vessels in the head." The labeling for Imitrex, however,
recommended that people with serious heart problems shouldn't be
prescribed the drug, indicating that Glaxo was, in fact, aware of its
potential effect on heart vessels.
But when reports began to file in at Health and Welfare about side
effects following an injection of Imitrex, Glaxo officials took the
public position that these reactions were rare and unexplainable. As
of July 1992, Health and Welfare had received only 20 voluntary
reports of adverse side effects associated with the use of Imitrex,
including severe chest pain and breathing difficulties. But by
November, an additional 70 reports had been filed, again including
chest symptoms. That month, Health and Welfare and Glaxo quietly
cooperated in rewording the product labeling. The new labeling advised
doctors to take a careful medical history to avoid prescribing Imitrex
to anyone with heart disease.
Meanwhile, in Britain (where Imitrex had been available since 1991), a
new chapter in the drug's story had begun. A case report was published
in May of 1992 in the British Medical Journal concerning a 47-year-old
man with no sign of heart disease who developed severe chest pain
after injections of Imitrex. Further tests with the patient showed
that within six minutes of receiving a shot, his heart vessels began
constricting. A month after this case was reported, the U.K. Committee
on Safety of Medicines, Britain's drug regulatory group, reported that
Imitrex could cause heart vessels to constrict.
Glaxo, however, continued to maintain that severe side effects were
rare, and that those patients who suffered heart-related complications
must have had some underlying heart problem.
In the United States, the FDA had the advantage of looking at several
months' worth of cases of side effects associated with Imitrex in
Canada, Britain, and the Netherlands before deciding whether to
approve the drug for the American market. Dr. Paul Leber, chief of the
FDA's Division of Neuropharmacological Drug Products, clearly
struggled with the decision. In an August 1992 memo to Dr. Robert
Temple, director of one of the FDA's three Offices for Drug
Evaluations, Leber questioned the value of Imitrex, writing that its
benefit was difficult to determine because of the absence of compariso
ns with alternative treatments (such as painkillers, anti-inflammatory
drugs, narcotics, and medications derived from a common fungus). "It
is particularly difficult to get a clear view," Leber wrote, "because
the product has been promoted worldwide with considerable vigor.
Indeed, one expert has privately communicated his belief that the
utility and advantages of Imitrex have been considerably inflated."
Four months later, with Imitrex on the verge of approval, Leber voiced
deep concerns about the drug's safety, particularly for patients who
might have undiagnosed heart conditions. In another memo to Temple,
dated Dec. 28, 1992, Leber wrote that if the drug is "widely used once
marketed, a sizable number of patients with significant, but
unrecognized, coronary vessel disease will be inadvertently exposed.a
If this occurs, it is probable, if not certain, that some of these
individuals will suffer serious harm, even death, following their use
of Imitrex injection. In fact, postmarketing reports from countries in
which Imitrex is available indicate that such events have already
occurred."
But despite this danger, Leber didn't want to stop FDA approval of
Imitrex. "What counts more?" he wrote. "The rights of millions of
otherwise healthy migraineurs to have access to an effective and, for
them, safe treatment, or the rights of those who may be inadvertently
injured by its marketing?--If there are to be potent drugs like
[Imitrex]--society must be willing to tolerate the injury they will
cause to some proportion of those who use them."
The FDA approved Imitrex for sale the next day.
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Pinkfloyd
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #11 on: Oct 30th, 2006, 9:36pm » |
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As part of its Imitrex information package to the press, the FDA
stated that "people with underlying heart disease should not take the
drug because of its potential to cause constriction of coronary
arteries." As a precautionary measure, the agency also recommended
that doctors consider giving the first injection in their office to
patients who might have underlying coronary heart disease.
But the drug's labeling included no recommendation to doctors to
exclude patients whom they only suspected could be at risk for
underlying heart disease. And there was no recommendation for how to
treat patients who seemed to be suffering a negative reaction.
Imitrex's reputation as a breakthrough migraine treatment was largely
made in the initial burst of promotion upon its release. It wasn't
until August 1994a20 months after the drug's approval--that the FDA
and Glaxo cooperated in making the first significant labeling change
for Imitrex. By this time, the number of reported deaths possibly
related to Imitrex had grown to at least 33. A new section was added
to the Imitrex label. Titled "Drug-Associated Fatalities," it
discloses that some of the reported deaths had occurred within a few
hours of Imitrex's use and that the drug's "specific contribution--to
most of these deaths cannot be determined." The death of Dianne Riley
is noted, though not by name, among them. (The notation, however, does
not mention that Riley's autopsy showed her to be free of heart
disease. Instead, it lists her risk factors for heart
disease--"positive family history, postmenopausal woman, and
smoking"--implying that she might have had heart disease.) The FDA
also asked Glaxo to send out what is known as a "Dear Doctor" letter,
to inform physicians of the labeling change.
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Glaxo's new drug may save migraine sales
Drug giant is losing patent on a migraine blockbuster but is spinning out a new combo drug.
October 12, 2005: 3:45 PM EDT
By Aaron Smith, CNN/Money staff writer
NEW YORK (CNN/Money) - GlaxoSmithKline will lose patent protection on a blockbuster migraine treatment in three years, but it may have figured out how to protect sales by spinning off the drug as a new combination product, analysts say.
GlaxoSmithKline (up $0.54 to $50.67, Research), a British drugmaker with $39 billion in 2004 sales, will lose its patent on Imitrex, a painkiller for migraines, in 2009. The drug has been a profitable part of the company's business: sales from Imitrex and a related drug, Imigran, totaled $1.2 billion in 2004.
GlaxoSmithKline filed a new drug application for Trexima with the Food and Drug Administration on Aug. 8. Trexima is a combination of two drugs: Imitrex, also known as sumatriptan succinate, and naproxen sodium, a generic drug found in the Bayer (down $0.62 to $35.57, Research) painkiller Aleve.
"The strategy is to meet an unmet medical need," said GlaxoSmithKline spokeswoman Mary Anne Rhyne. "We want a full pipeline of products to help migraine sufferers."
The FDA said on Oct. 11 that it had accepted the Trexima application for review.
"This drug has a very high likelihood of success," said Bernstein analyst Gbola Amusa, who estimates a 95 percent chance of FDA approval for Trexima.
Bernstein projects that GlaxoSmithKline sales for Trexima will total $1.4 billion in 2010, the first full year without an Imitrex patent. Amusa said that GlaxoSmithKline has a history of successfully spinning off drugs into profitable new products, having turned Paxil into Paxil CR and Wellbutrin into Wellbutrin XL.
Not every analyst is convinced. Peter Cartwright, analyst for Williams de Broe, described Trexima as "a little tweak to the existing product lineup" and said that GlaxoSmithKline would be able to hold on to some of its sales revenue from migraine treatments if Trexima is approved. However, he said the drug would probably not achieve blockbuster status.
"This combination would not, I don't think, be able to defend $1 billion in sales," said Cartwright. The analyst said the market for migraine painkillers is "mature," with no room to expand.
Irina Stratan, an analyst for WestLB Equity Markets, projects that the FDA will approve Trexima in June 2006, and that sales will reach $390 million in 2009.
Stratan, however, said that Trexima sales could eventually surpass Imitrex sales and reach blockbuster status.
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Jonny
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #12 on: Oct 30th, 2006, 9:38pm » |
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on Oct 30th, 2006, 9:27pm, Pinkfloyd wrote:"This is a simple case
where a young woman took Imitrex, started to react to it badly,
developed an irregular heartbeat, and died. |
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Seems to me that this could happen with aspirin or cough syrup depending on the person........you just never know when shit is going to hit the fan, no?
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It is up to YOU to educate yourself and then help your doctor plan your treatment. If you just sit down in front of your doctor and say "make me better" you are setting yourself up for a great deal of pain.
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Pinkfloyd
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #13 on: Oct 30th, 2006, 9:39pm » |
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Latest....warning
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Triptans
and.....FDA wants to take another look at trexima........
Monday July 31, 02:05 PM
POZEN to respond to FDA's request for further Trexima safety information
LONDON (AFX) - POZEN Inc (NASDAQ: POZN - news) said it plans to submit a full response to the US Food and Drug Administration's request for further safety information on its Trexima migraine relief drug during the fourth quarter.
The drug maker said the full response will include additional safety information and comes after POZEN and development partner GlaxoSmithKline PLC (LSE: GSK.L - news) met with the FDA to discuss and agree a plan for responding to the FDA's approvable letter.
The FDA will have up to six-months to review the information contained in the full response.
and.....
http://www.businessweek.com/ap/financialnews/D8FH2URO4.htm?campaign_id=a pn_home_down&chan=db
GSK gets FDA OK for new Imitrex dose
FEB. 2 11:12 A.M. ET Drug maker GlaxoSmithKline PLC said Thursday that
the Food and Drug Administration approved a lower dose formulation of
migraine treatment Imitrex that can be administered with an injector
pen.
The new formulation allows migraine patients to use the Statdose
System injector pen to administer a 4 milligram dose of Imitrex.
Previously, the lowest dose approved for the Statdose was 6
milligrams.
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and to remind you of how some things operate at the FDA.....which has our safety at heart...
WASHINGTON, DC - July 20, 2006 - The Union of Concerned Scientists (UCS) today released survey results that demonstrate pervasive and dangerous political influence of science at the Food and Drug Administration (FDA). Of the 997 FDA scientists who responded to the survey, nearly one-fifth (18.4 percent) said that they "have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document." This is the third survey UCS has conducted to examine inappropriate interference with science at federal agencies.
"Science must be the driving force for decisions made at the FDA. These disturbing survey results make it clear that inappropriate interference is putting people in harm's way," said Dr. Francesca Grifo, Senior Scientist and Director of UCS's Scientific Integrity Program. "FDA leaders should act now to improve transparency and accountability and renew respect for independent science at the agency."
The UCS survey, which was co-sponsored by Public Employees for Environmental Responsibility, was sent to 5,918 FDA scientists. Forty percent of respondents fear retaliation for voicing safety concerns in public. This fear, scientists say, combines with other pressures to compromise the agency's ability to protect public health and safety. More than a third of the respondents did not feel they could express safety concerns even inside the agency.
"This is more than just a bureaucratic problem within the agency," said Kim Witczak, WoodyMatters.com, who lost her husband due to side effects of a dangerous anti-depressant.
"It has real human impacts which can be devastating. My husband paid the ultimate price for FDA's lack of accountability."
The survey also revealed other compelling points of concern:
* 61 percent of the respondents knew of cases where "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."
* Only 47 percent think the "FDA routinely provides complete and accurate information to the public."
* 81 percent agreed that the "public would be better served if the independence and authority of FDA post-market safety systems were strengthened."
* 70 percent disagree with the statement that FDA has sufficient resources to perform effectively its mission of "protecting public health - and helping to get accurate science-based information they need to use medicines and foods to improve their health."
"The FDA regulates products vital to the well-being of all Americans, including food, drugs, vaccines, and medical devices," said Dr. Grifo. "To fully protect public health and safety, the FDA must have the best available independent scientific data."
To address the concerns raised by FDA scientists, UCS recommends:
* Accountability: FDA leadership must face consequences if they side with commercial or political interests and not with the American people.
* Transparency: Scientific research and reviews should be open so any undue manipulation is immediately apparent.
* Protection: Safeguards must be put in place for all government scientists who speak out.
"What we see at the FDA, while dramatic and frightening, is all too common at many federal agencies," said Dr. Grifo. "All federal scientists need protections so they can speak out when their science is manipulated, and all federal agencies need fully functioning independent advisory committees. FDA leadership must understand and support independent science and it is up to Congress to hold them accountable."
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www.obscuredview.blogspot.com
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Pinkfloyd
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #14 on: Oct 30th, 2006, 10:06pm » |
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on Oct 30th, 2006, 9:38pm, Jonny wrote:
Seems to me that this could happen with aspirin or cough syrup depending on the person........you just never know when shit is going to hit the fan, no?
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You're absolutely correct jonny.
I just couldn't let stand, the notion, coming from a doctor, that there are/were no Imitrex overdoses, which would open the door for a lot of people here, to not be as careful as they might otherwise be.
As of 1995: To date, the Food and Drug Administration has received 3,526 voluntary reports of possible side effects, ranging from mild to severe, associated with the use of Imitrex. Included are reports of 83 deaths
and at least 273 life-threatening complications.
I want what you do...people to be safe and smart about what they put into their bodies, and if they start getting adverse symptoms, they have some idea about what it might be causing them. To be told you can't OD on Imitrex puts some bad info into people's minds, IMHO.
Also..please pardon the way the posts came out. Cut and paste into smaller posts to fit sometimes causes that and I don't have time to fix em...sorry. I know it made it difficult to read.
peace out ~
Bobw
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[Michel de Montaigne
www.clusterbusters.com
www.obscuredview.blogspot.com
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purpleydog
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #15 on: Oct 30th, 2006, 10:06pm » |
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Quote: "The strategy is to meet an unmet medical need," said GlaxoSmithKline spokeswoman Mary Anne Rhyne. "We want a full pipeline of products to help migraine sufferers."
The FDA said on Oct. 11 that it had accepted the Trexima application for review.
"This drug has a very high likelihood of success," said Bernstein analyst Gbola Amusa, who estimates a 95 percent chance of FDA approval for Trexima.
Bernstein projects that GlaxoSmithKline sales for Trexima will total $1.4 billion in 2010, the first full year without an Imitrex patent. Amusa said that GlaxoSmithKline has a history of successfully spinning off drugs into profitable new products, having turned Paxil into Paxil CR and Wellbutrin into Wellbutrin XL. |
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Successful history of spinoffs? This is all about the $. Nothing more greedy than a drug company. They have the $ to bribe almost anyone to get a drug approved. Whether the effects, or contraindications are fully disclosed or not.
Thanks for the info, Bob.
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pattik
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #16 on: Oct 30th, 2006, 10:39pm » |
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on Oct 30th, 2006, 9:26pm, purpleydog wrote:
It would be irresponsible of a doctor to dispense medical advice over the internet, or in any other forum without knowing the person, or examining him or her first. Not to mention opening themselves up to all kinds of lawsuits. |
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I have to totally agree with you, Chris. I have yet to meet a medical doctor in person who does not understand the importance and gravity of your statement.
Jellyneen, read the oxygen information (link to the left). You may find, as many of us do, that used correctly, oxygen can reduce your need for so much Imitrex.
patk
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| « Last Edit: Oct 30th, 2006, 11:39pm by pattik » |
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BB
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #17 on: Oct 31st, 2006, 4:00am » |
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First of all thank you for all the information posted, very informative.
Secondly, I wish to make it very clear ( I thought I had ) that I am not here to dispense medical advice in place of peoples doctor(s) or therapist(s). I have alway urged people to go to their own doctors for checkup.
I am a doctor and I practice medicine in Sydney, yes , I dont hide that fact. I have let people know that I am a GP and not a specialist. I made it clear at the beginning that I am here as a supporter for my husband who has CH. I have always freely admitted that I dont know much about CH but I am trying to learn as much about it and as quickly as possible.
I have never prescribed any treatment to anyone here as their doctor nor do I intent to. I dont gain any monetary or material things out of being here. I am here to learn about the condition to help my own husband and to try to do some good for everyone, supporters and sufferers alike. Anyone who has been following my posts will notice that I always urge caution, not giving reckless information.
To say that reading my post will cause people to overdose on Imitrex is flaming, to say the least. Where did I say that I recommend taking more than12 mg per day? Overdosing means taking more than the recommended dose causing illnesses or death. It doesnt mean taking the medication for the first time and experiencing adverse effects. The example you quoted about spontaneous splenic infarction did not specify the dose taken nor the length. The other death you quoted was not from overdose, it was the first time she took the injection. These are classified as adverse effects not overdose. Adverse effects can happen with any dose and may not even be dose related. But then here we are not talking about adverse effects. I have checked and rechecked again with the Pharmaceutical Board and the Poison Centre here in Australia and there has not been report of dangerous overdose in clinical practice.
I believe what you are saying is that Imitrex ican be dangerous. I agree with you entirely on that. Any medication is potentially dangerous. But report of dangerous overdosing, has not been noted , at least in Australia. Potentially dangerous adverse effects ? yes. Jellyneen was prescribed Imitrex by her doctor who would or should have advised her on the adverse effects. She had also been advised that the recommended daily dose is 12 mg, but like many CHers, she is finding that difficult to stick to as she obviously has had more than 2 attacks per day and has had to use more than 12 mg per day.
There are many CHers, under the guidance of their doctors and specialists, take more than 12 mg per day, as a necessity. And no, the ones who are taking up to 8 injections per day are not my patients and I dont prescribe like that, its usually the specialists who do so.
Here is one example of why doctors are so reluctant to help, such as prescribing oxygen. Many medications used for CH are outside the normal recommended range or usage. A doctor steps out of that, even with the genuine intention to help and to care, will get ridiculed and threatened with legal actions.
I also can see why no other doctor stay around. Why expose yourself to such risk ?
I am not ashamed to say though that every thing I do or say here is with the best intention and with the most sincere wish to help out. If in doing so, I unwittingly expose myself to chances of being sued then sue me.
Being a carer is definitely more tricky.
Painfree wishes to all. Hope some of you do find my efforts here helpful and please I am not here to replace anyone doctors.
Annette
Edited for spelling mistakes
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| « Last Edit: Oct 31st, 2006, 4:06am by BB » |
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pattik
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #18 on: Oct 31st, 2006, 9:26am » |
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on Oct 31st, 2006, 4:00am, BB wrote:
I am a doctor and I practice medicine in Sydney, yes , I dont hide that fact. I have let people know that I am a GP and not a specialist. |
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Thank you for clearly stating that. I hope you will also clearly state when and from where you received your medical degree, and which hospital and clinic you currently practice medicine in Sydney. If you are uncomfortable posting this information publicly, you can PM me. You may have casually made statements in your posts disclaiming your knowledge of neurology, but there are many readers here, old and new, who have not read those statements, have the general idea that you are a doctor, and may take your advice without question. Perhaps DJ needs to post a disclaimer at the top of every board stating that any and all advice here is up for interpretation.
patk
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BB
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #19 on: Oct 31st, 2006, 10:17am » |
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I studied and graduated from the Medical School of Auckland New Zealand in 1995, obtained a BHB ( Bachelor of Human Biology ) and a MBChB ( Bachelor of Medicine and Bachelor of Surgery ) , did my internship at Auckland hospital, Greenlane hospital and Middlemore hospital in Auckland, then did my residency at Westmead hospital, Blacktown hospital and Orange hospital in Sydney, completed GP training at the Royal College of GP Australia and have been working at various medical centres in Sydney. Currently involved in Post Grad study for Obstetric and Paediatric.
Anyone else curious as to where I am now working can PM me.
Anyone visiting this Board should use common sense and know not to take ANY advice/suggesstion given by ANYONE here as absolute, only as information that needs to be clarified/discussed with their own doctor/specialist.
I am definitely not a neurologist, I dont think any neurologist would ever post here, and I think doctors in general shouldnt post here either, the risk of a lawsuit is just too much.
Annette
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BikerBob
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #20 on: Oct 31st, 2006, 11:22am » |
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The question was "Can I OD on Imitrex?", "Can I overdose on this stuff?". Clearly, the answer is yes. Leading people to believe otherwise while claiming to be a doctor is very dangerous. Some newbie might use four Imitrex injections in less than two minutes during a CH attack and die.
BB
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Margi
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #21 on: Oct 31st, 2006, 11:40am » |
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Folks....please..... Can everyone just take a breath here and understand that Annette is new to cluster headaches, new to supporting and she's just learning about the affliction.
Isn't that what this place is about? Educating folks INCLUDING doctors?
So Annette gave the response that most GP's would have. What about Tracy's doctor....he prescribed her Imitrex AND Zomig, right? Tracy ended up having a heart attack because of that mixture. I bet that doctor will never prescribe two triptans again, will he? Doctors are human too, folks. I'm betting Annette has learned a lot in this thread. No need to keep smacking her on the nose with a newspaper, gang - come on. Enough! 
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| « Last Edit: Oct 31st, 2006, 11:41am by Margi » |
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MJ
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #22 on: Oct 31st, 2006, 1:16pm » |
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"News: Imitrex, a popular new drug for treating migraines, has been associated with hundreds of life-threatening problems and deaths. So why do the FDA and Glaxo, the drug's manufacturer, both claim that it's safe? "
Thanks BobW
I think its important to know all the info as we as clusterheads too often, too quickly accept whatever the drug companies or medical practitioners tell us as gospel. As stated, there is a risk associated with everything. The risks must be noted and weighed.
Here is the rest of the 95 Mother Jones article http://www.motherjones.com/news/feature/1995/09/regush.html
I used the shots up to 10 times a day back in the early 90s and "fortunately" had no known adverse medical responses. Nor was I rid of the pain of CH.
But the trex definately extended my cycles.
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MJ
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purpleydog
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #23 on: Oct 31st, 2006, 2:15pm » |
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BB said:
Quote:| I have alway urged people to go to their own doctors for checkup. |
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Then:
Quote:| I am not ashamed to say though that every thing I do or say here is with the best intention and with the most sincere wish to help out. If in doing so, I unwittingly expose myself to chances of being sued then sue me. |
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Then:
Quote: Anyone visiting this Board should use common sense and know not to take ANY advice/suggesstion given by ANYONE here as absolute, only as information that needs to be clarified/discussed with their own doctor/specialist.
I am definitely not a neurologist, I dont think any neurologist would ever post here, and I think doctors in general shouldnt post here either, the risk of a lawsuit is just too much.
Annette |
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My concern is with the inconsistency of BB's posts.
As everyone who reads up here SHOULD indeed check with their doctor before trying anything different with their meds, not everyone will. They will see that a doctor (specializing in obstetrics) is recommending dosages to take for trex, and even saying you can't OD from trex, among other things. What is a person to think? Especially a newbie.
I agree with you, Patti. DJ should definitely put up a disclaimer about medical suggestions. Especially, as he could be held liable in any lawsuit that may be brought, because he owns the website.
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Margi
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Re: What is Taurine? Can I OD on Imitrex???
« Reply #24 on: Oct 31st, 2006, 2:21pm » |
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on Oct 31st, 2006, 2:15pm, purpleydog wrote:| I agree with you, Patti. DJ should definitely put up a disclaimer about medical suggestions. Especially, as he could be held liable in any lawsuit that may be brought, because he owns the website. |
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Uh, he already has, Chris. One would think a former OUCH Officer would know this.
"DISCLAIMER: All information contained on this web site is for informational purposes only. It is in no way intended to be used as a replacement for professional medical treatment. clusterheadaches.com makes no claims as to the scientific/clinical validity of the information on this site OR to that of the information linked to from this site. All information taken from the internet should be discussed with a medical professional!"
Right on the home page of ch.com.
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And, on the Eighth Day...God created Beer (to stop the Canadians from taking over the world)
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IMHO (which in my universe is correct)
kathy copelin, ch.com 8/8/06
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