Public Citizen Calls on FDA to Ban Arthritis Drug

[Guest guest]

Public Citizen Calls on FDA to Ban Arthritis Drug

Thu Mar 28, 5:20 PM ET

By Richwine

WASHINGTON (Reuters) - The US consumer group Public Citizen on Thursday

urged regulators to immediately ban the rheumatoid arthritis drug Arava

(leflunomide), saying it had linked the product to 12 fatal cases of

liver damage.

Arava's risks outweigh its benefits, which are no better than those

offered by an older, commonly used treatment, Public Citizen asserted in

a petition to the Food and Drug Administration (news - web sites) (FDA).

From September 1998, when Arava debuted in the United States, to

September 2001, the FDA received 130 reports of severe liver problems in

patients taking Arava, Public Citizen claims. For 12 cases that were

fatal, liver damage from Arava " appears to be the most plausible

explanation, " the group said.

Officials at Arava's maker Aventis SA, which reported worldwide sales of

258 million euros ($225 million) for Arava in 2001, were not immediately

available for comment.

Public Citizen said it also found reports of lymphoma and drug- induced

hypertension in people treated with Arava, as well as skin, blood and

gastrointestinal reactions serious enough to cause hospitalization. In

clinical trials, Arava's effectiveness was less than or equal to that of

methotrexate, a drug commonly used to treat the painful and swollen

joints of rheumatoid arthritis, Public Citizen said, adding that fewer

serious reactions have been reported with methotrexate.

Patients also have other treatment options, according to the group. " With

a variety of better drug treatments available, there is no reason to

subject patients to an accumulating list of added risks. [Arava] should

be promptly removed from the market, " the petition said.

Dr. Yocum, director of the Arizona Arthritis Center, also said

Arava should be pulled from the market. One of his patients treated with

Arava and another drug died from liver failure, but he acknowledged that

he was uncertain whether either or both drugs were to blame. He said

insurers pressure him to use Arava if methotrexate does not work because

other options cost more.

Public Citizen's data are " worrisome " because Arava's possible side

effects appear " idiosyncratic and unpredictable, " said Yocum, who

previously headed an FDA advisory panel that reviews arthritis drugs.

Yocum was excluded from the panel's review of Arava because he had taken

part in clinical trials of the drug.

FDA officials were not immediately available for comment.

About a year ago, the European Medicines Evaluation Agency warned that

severe liver reactions--some with fatal outcomes--have occurred in

patients treated with Arava. In a public statement on its Web site, the

agency said a total of 296 liver reactions had been reported by that

time, with 129 cases considered serious and nine having a fatal outcome.

The statement acknowledged that confounding factors were often present,

but said that a relationship to leflunomide could not be ruled out.

http://story.news./news?tmpl=story & cid=594

& u=/nm/20020328/hl_nm/arthritis_consumers_1

[Guest guest]

Well,

I took Arava for about a year before the doc and I decided (actually I

decided long before he would admit it) that it was probably not effective and

I went on to Enbrel and mtx. Apparently, I had no liver side effects from

either the Arava or the mtx unless it stays in the body for a long time which

I don't think I read. Must have a pretty strong liver (probably explains my

college drinking experiments!).

I have just finished making 5 Easter baskets for the girls, husband and new

boyfriend and now must hide 36 eggs. The Easter Bunny/Tooth Fairy/Santa

Claus is just getting too old for this stuff!!!! Well, maybe not too old,

just a little (or a lot) slower!!

While I am waiting for everyone to get to sleep, watching my favorite Easter

movie (I think the only one made actually) Easter Parade......Ahhhhhhh they

don't make em like that anymore!

Happy Easter,

Deb

[Guest guest]

June,

I'm really glad I didn't take it. I was prescribed it but the doctor decided to

wait to see what

was going on with my period stopping abruptly, and wound up putting me on mtx.

Since

the mtx affected my liver right away, I'm sure the Arava would have too.

So sorry you're flaring, I sure hope you get relief before your holiday dinner

tomorrow.

Glad you like the bread so much. I have to make a loaf every day for my

family. My

daughter has to stop by daily just to have it toasted with jelly. It makes

excellent toast.

I tried your wheat bread and it was very tasty and had great texture. I'm

taking a hiatus

from wheat for awhile so I have to give up all this great tasting bread

Since I've been

making all this wonderful bread, my joints are hurting more, so I figured it

won't hurt to

try eliminating wheat since it is know to cause inflammation. I was also eating

cream

of wheat for breakfast a lot, so I was eating a lot of wheat. I've never tried

giving up

all wheats, so it will be interesting to see if it makes a difference.

God bless you and your family.

a

[ ] Public Citizen Calls on FDA to Ban Arthritis Drug

Kind of scary a, this is the drug I was on for only 2 mos and it affected

my liver. Not much wonder we all hate our meds.

Welcome to our new members,look forward to getting to know you. I am in a

large flare today,hopefully it will let up for tomorrow since I have 14 family

members for dinner. Fortunately I have the best DIL's in the world and they will

do most of it.

To all of you,God Bless and give you some relief from the seemingly

unrelenting pain.

Hugs

June

ps: a,I have made your recipe for Honey Oatmeal bread about a dozen

times,it is now my favourite. I double the recipe and just use my ABM to mix the

dough,then shape it in loaves and bake in the oven.

[Guest guest]

Hi All: I read about the Arava. I had been on it in January and Feb., my

legs worked wonderful, no pain, moving great but----I felt so lousy

otherwise, constant problems with my bowels (if you get my drift), seemed

like I virtually no energy and seemed blouted. Felt like my bladder wasn't

working right. Also broke out in a horrible, ugly rash on my torso. I just

quit taking it. I go back to dr on this month, and he will probably be mad as

h---, but the side effects didn't make it worth it for me. After reading the

article in the paper it says it does the same as mtx and I am still taking

it. So why add this??? Sometimes I wonder if the drs just like to plug new

meds...

jan

[Guest guest]

hey, a,

How about reprinting that receipt?