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> Though I've been told that those ofus n Mtx shouldn't be drinking

> anyway.

Yeah, my rh asked if I drank before he decided to put me on Arava

or MTX, apparantly Arava isn't so hard on the liver...

> Just wondering if you know that if you are

> taking Vicodin, be very careful about taking tylenol

> or any acetaminophen's. As Vicodin or hydrocodo has

> acetaminophen in it too much can cause Liver Problems,

> Kidney Disease, Overdose of the Drug Acetaminophen.

Yeah, thx, , I'm careful. Matter of fact, since I

need to go up on the Vicodin, the rh prescribed the 7.5/500s

so even at 2 I won't be exceeding the extra strenth dose.

But I'm on Phenobarb, too, which is bad for the liver.

Since the Vicodin only cuts the pain at this point, I'm

wondering about stronger pain meds. Yours sound pretty strong.

How " bad " (I know that's a relative term) is your RA? And/or what kinds

of pain do you have? Mine is recently diagnosed, my tests and

xrays are negative, but man, does it hurt :) Dunno that

my rh would consider putting me on anything stronger yet, tho...

Thx,

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I was actually told tha Arava is MORE dangerous than MTX and has had

many cases of sudden liver failure. When I was on Arava I had to

have bloodwork to monitor liver function every two weeks like clock

work.

I found this site that might explain it. I do know there were also

some lawsuites from people who have been permenently injured or have

died from this drug. A rheummy that I have before refused to use

Arava due to its history of sudden serious liver damage.

Ihope this helps.

http://www.bruha.com/pfpc/html/arava.html

Arava

© 2001 PFPC

April 2, 2002

Dear All,

Yet another fluorinated drug called Leflunomide ( " Arava " ) is being

considered for market removal, and - once again - because of

observed liver and cardiac toxicity. Please read the press release

below, issued by the Public Citizen Group. Additional info follows

the press release.

===================================

March 28, 2002

Arthritis Drug Should Be Removed From Market

Arava Linked to Liver Complications and Deaths, Public Citizen Tells

FDA

WASHINGTON, D.C. - A prescription arthritis drug has been linked to

an alarmingly high number of severe liver problems, including deaths,

since it came to the market in 1998 and should be taken off the

market immediately, the consumer group Public Citizen said today in a

petition to the Food and Drug Administration (FDA).

Arava, also known as leflunomide and produced by Aventis, was first

marketed in the United States in September 1998 to treat rheumatoid

arthritis. Over the next three years, it was associated with at least

130 cases of severe liver toxicity, including 56 hospitalizations and

12 deaths, according to FDA data. Two of those who died were in their

20s.

" To have this many deaths and severe reactions over such a short time

is truly disturbing. " said Dr. Sidney Wolfe, director of Public

Citizen's Health Research Group, which submitted the petition. " When

there are other treatments that are more effective and don't endanger

patients as much as this drug, there is absolutely no reason for the

FDA to keep Arava on the market. "

In a comparison between Arava and methotrexate, which is an equally

or more effective drug for treatment of rheumatoid arthritis, Public

Citizen found that over the three-year period it has been on the

market, Arava was linked to six times more cases of fatal liver

toxicity and 13 times more reports of hypertension than methotrexate,

although there were 6.8 million (5.5 times) more prescriptions filled

for methotrexate than Arava during that time. Additionally, Arava has

been associated with 12 cases of the life-threatening autoimmune

disease s- Syndrome, and methotrexate with none.

Another danger of the drug is that it remains in body tissues for an

extremely long time. Warnings already on its packaging suggest that

byproducts could remain in the body for months, so that even if

patients stopped the drug after an adverse reaction started, the

damage could continue to affect patients for months.

Public Citizen's petition is supported by Dr. E. Yocum,

director of the Arizona Arthritis Center at Arizona Health Sciences

Center, who recently ended a tenure as chair of the FDA's Arthritis

Drugs Advisory Committee. Yocum said he agrees that the drug should

be withdrawn from the market.

" I do not believe that the general rheumatologist understands or has

any knowledge about these serious and potentially life-threatening

complications, " Yocum said in a letter to Wolfe. " I also agree that

providing a black box warning concerning these issues may not be

effective since no one can predict who will suffer from these

complications. "

Yocum has recently reported to the FDA the death of one of his

patients from acute liver failure after using Arava.

After similar serious reactions to leflunomide in Europe, the

European Agency for the Evaluation of Medicinal Products issued an

urgent warning last year to patients and doctors about the drug's

toxicity.

" Before it was approved by the FDA, there was evidence that

leflunomide led to liver complications, and now the dangers are even

clearer, " Wolfe said. " No more patients should be subjected to these

risks. "

http://www.citizen.org/pressroom/release.cfm?ID=1067

==================================

MORE INFO

In 2001 the WHO/EMEA reported of a total of 296 cases with hepatic

reactions implicating Leflunomide. Of these, 129 cases were

considered as serious, including 2 cases of liver cirrhosis and 15

cases of liver failure, 9 with fatal outcome. The hepatic reactions

appeared within 6 months of initiation of treatment (1).

Leflunomide is another drug containing a fluorophenyl compound.

Numerous drugs containing fluorophenyl compounds have been withdrawn

in recent years, or 'Health Alerts' issued - for identical reasons

(2,3).

Tolrestat, a diabetic drug, was withdrawn in 1997 for having

severe liver toxicity (2,3). In 1998, Flutamide, an anti-cancer drug,

was also found to cause liver dysfunction, and health warnings were

issued (4). In 1999, trovafloxacin and alatrofloxacin (Trovan) were

found to cause severe liver disease (5). As you might remember,

Baycol was withdrawn last year (2, 3). Prozac is still on the market.

Already in 1999, BEFORE it had been approved for the European

market for treatment of rheumatoid arthritis, the European Medicines

Evaluation Agency (EMEA) issued a public statement alerting that

Leflunomide (then Hoechst, now Aventis) had been associated with

reports of pancytopenia and serious skin reactions (6), just like

other fluorinated drugs, such as the fluoroquinolones (2,3), or

fluorinated steroids and other fluorides (7). [Pancytopenia ->

Deficiency of all cell elements of the blood, aplastic anaemia]

DRUG METABOLISM

Leflunomide is another example of the parent compound not being

the active compound, as was discussed previously regarding

sevoflurane.

The drug is metabolized into a compound commonly referred to as

A77 1726, a 4-trifluoromethylphenyl-containing compound (8,9).

A77 1726 suppresses tyrosine kinases involved in signal

transduction pathways.

Tyrosine is the precursor for thyroxine (T4).

In the liver, such compounds inhibit glutathione - absolutely

essential for peripheral thyroid hormone T4 to T3 conversion - in a

direct dose and time-dependent fashion (10), thus acting like other

anti-thyroid drugs, such as PTU, which cause artificial " selenium

deficiency " (11).

For over 70 years the pharmaceutical companies have known that ALL

fluoride compounds are poisons to the liver, and may thus cause

serious thyroid hormone imbalances.

How many more years and drugs and deaths and 'Health Alerts' will

it take before somebody - at any drug-regulatory body anywhere -

actually pays any attention?

Small & s Schuld

Parents of Fluoride Poisoned Children (PFPC)

Vancouver, BC, Canada

REFERENCES:

1) WHO Health Alert #101: " Leflunomide - severe and serious hepatic

reactions " (March 2001)

2) PFPC NEWS August 2001

http://www.mercola.com/2001/aug/18/fluoride_drugs.htm

3) Malaysia Poison Control Center

http://www.prn.usm.my/bulletin/nst/2001/nst34.html

4) WHO Health Alert #73: " Flutamide - warning concerning severe

hepatic dysfunction " (August 25, 1998)

5) WHO Health Alert: #85: " Trovafloxacin and alatrofloxacin : serious

severe and unpredictable liver injuries " (May 28, 1999)

6) WHO Health Alert #91: " Leflunomide: reports of pancytopenia and

serious skin reactions " (November 11, 1999)

7) PFPC: " Telangiectases "

http://64.177.90.157/science/html/telangiectases.html

8) Mirmohammadsadegh A. et al. - " Differential Modulation of Pro- and

Antiinflammatory Cytokine Receptors by N-(4-trifluoromethylphenyl)-2-

cyano-3-hydroxy-crotonic acid

amide (A77 1726).The Physiological Active Metabolite of the Novel

Immunomodulator Lefluonomide " Chemical Abstracts, vol. 129, No. 3

(Jul. 20, 1998)

9) , J. et al. - " 3-carboxy-5-methyl-N-[4-(trifluoromethyl)

phenyl]-4-isoxazolecarboxamide. New Prodrug For The Antiarthritic

Agent 2-cyano-3-hydroxy-N-[4-(trifluoromethyl) phenyl]-2-butenamide "

Chemical Abstracts, vol. 116, No. 9 (Mar. 2, 1992)

10) DC, Perera K, London R - " Spontaneous hydrolysis of 4-

trifluoromethylphenol to a quinone methide and subsequent protein

alkylation " Chem Biol Interact 126(1):1-14 (2000)

11) Veronikis IE, Braverman LE, S, Fang SL, Norvell B, Emerson

CH - " Comparison of the Effects of Propylthiouracil and Selenium

Deficiency on T3 Production in the Rat " Endocrinology 137 (6):2580-

2585 (1996)

>

> > Though I've been told that those ofus n Mtx shouldn't be

drinking

> > anyway.

>

> Yeah, my rh asked if I drank before he decided to put me on Arava

> or MTX, apparantly Arava isn't so hard on the liver...

>

> > Just wondering if you know that if you are

> > taking Vicodin, be very careful about taking tylenol

> > or any acetaminophen's. As Vicodin or hydrocodo has

> > acetaminophen in it too much can cause Liver Problems,

> > Kidney Disease, Overdose of the Drug Acetaminophen.

>

> Yeah, thx, , I'm careful. Matter of fact, since I

> need to go up on the Vicodin, the rh prescribed the 7.5/500s

> so even at 2 I won't be exceeding the extra strenth dose.

> But I'm on Phenobarb, too, which is bad for the liver.

>

> Since the Vicodin only cuts the pain at this point, I'm

> wondering about stronger pain meds. Yours sound pretty strong.

> How " bad " (I know that's a relative term) is your RA? And/or what

kinds

> of pain do you have? Mine is recently diagnosed, my tests and

> xrays are negative, but man, does it hurt :) Dunno that

> my rh would consider putting me on anything stronger yet, tho...

>

> Thx,

>

>

>

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How right you are Toni. I had really hoped that with all the negative

publicity,

Arava would be pulled off the market. Public Citizen is trying to get

it pulled.

There are just to many serious adverse affects. Hopefully those on it

are

following through with regular lab tests.

a

On Mar 19, 2006, at 7:51 PM, Ms radar wrote:

> I was actually told tha Arava is MORE dangerous than MTX and has had

> many cases of sudden liver failure. When I was on Arava I had to

> have bloodwork to monitor liver function every two weeks like clock

> work.

>

> I found this site that might explain it. I do know there were also

> some lawsuites from people who have been permenently injured or have

> died from this drug. A rheummy that I have before refused to use

> Arava due to its history of sudden serious liver damage.

>

> Ihope this helps.

>

> http://www.bruha.com/pfpc/html/arava.html

>

> Arava

> © 2001 PFPC

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a,

The strange thing is that Arava was the only med that worked well for

me and with no side effects. However when I changed rheummy's the

new one refuses to prescribe this drug unless its a last resort. He

says the risks of sudden liver failure are just took risky.

Yes, all the labwork was a real pain in the butt...but well worth it

considering the other possibilities of no labwork!

Toni

>

> > I was actually told tha Arava is MORE dangerous than MTX and has

had

> > many cases of sudden liver failure. When I was on Arava I had to

> > have bloodwork to monitor liver function every two weeks like

clock

> > work.

> >

> > I found this site that might explain it. I do know there were

also

> > some lawsuites from people who have been permenently injured or

have

> > died from this drug. A rheummy that I have before refused to use

> > Arava due to its history of sudden serious liver damage.

> >

> > Ihope this helps.

> >

> > http://www.bruha.com/pfpc/html/arava.html

> >

> > Arava

> > © 2001 PFPC

>

>

>

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