7/14/2010 Federal regulators are again putting doctors and patients on notice about the risk of severe liver damage connected with the use of the rheumatoid arthritis drug leflunomide (Arava).
The U.S. Food and Drug Administration (FDA) first ordered that a bolded warning about the risk of liver injury be added to leflunomide's label in 2003.
That caution came after at least 130 cases of severe liver damage, including 56 hospitalizations and 12 deaths, were connected to its use, according to FDA data reported by Public Citizen, a non-profit, consumer watchdog organization.
But after continued reports of hospitalizations and deaths, the agency updated that review and identified 49 more cases of severe liver injury associated with the medication, which led to hospitalization in 36 cases and 14 deaths between August 2002 and May 2009.
As a result, regulators have ordered that the liver injury warning be boxed and placed more prominently at the top of the label; and they have issued new alerts for doctors and patients, warning that leflunomide is not safe for people who have preexisting liver disease like hepatitis, those who have elevated levels of liver enzymes or a history of alcohol abuse.
Also, people who take other drugs associated with liver injury like acetaminophen (Tylenol), non-steroidal anti-inflammatory drugs (NSAIDs) – including ibuprofen (Motrin, Advil) and naproxen (Alleve), hydroxychloroquine and statins should use leflunomide with caution.
The FDA says patients taking leflunomide need to have blood tests to check their liver enzyme levels every month for the first three months of use and every three months thereafter.
Doctors prescribe leflunomide, a disease-modifying anti-rheumatic drug that has been on the market since 1998, to help stop rheumatoid arthritis, a disease caused by an autoimmune attack on the joints and organs.
And many rheumatologists say that though this enhanced caution is an important reminder, they have long known that leflunomide is not a drug to use when liver injury is a concern.
“With proper monitoring, Arava is an effective drug which I do not hesitate to use,” says Robert Shaw, MD, a rheumatologist at the Carroll County Arthritis and Osteoporosis Center in Baltimore, Md., and member of Arthritis Today’s Medical Advisory Board.
Others, however, think the drug is too risky.
In 2002, Public Citizen petitioned the FDA to remove the drug from the market, noting that in the three-year period after the drug’s approval, there were six times as many cases of fatal liver toxicity and 13 times more reports of hypertension linked to the use of leflunomide as were connected to a similar medication, methotrexate, though there were 6.8 million more prescriptions filled for methotrexate than leflunomide during that time.
My rheumy put me on this way back in the early 90's, telling me it was completely safe. i took one tablet at night and one in the morning. before lunch time i was sweating on my backside and very itchy. i had developed a raised up redness over my entire buttocks, as if i had sat on a hot
pizza tin. Doctor said it was remarkable.
I stopped the Celebrex immed. and it took six
weeks to go away.
MESSAGE TO ALL; R.A. is mainly a stress- related disease.
Until now. I can no longer obtain this drug due to a few who had an adverse reaction. They are forcing the vast majority whom it helped to return to the pain. What is next, stop selling peanuts because a few are allegic? I am sick of attornys and their lawsuits and big government control.
She has been taking Enbrel for last 5 years approx. and Jan 2010 started taking Leflunomide and stopped end of November 2010. She is experiencing severe blood count drop in white blood cells and platelets and hemacrit. She gets extremely fatiqued in the afternoon. If Alice reads this, how long did it take you to recover from your symptons?
Thanks for any input.
Julie Schlax
Watch my diet, eat only organics, no meat except wild fish, no trans fats, cholestrol, GMO's. Never smoked. Keep busy, exercise. No other health problems except R.A.
Volunteer in various churches, ham radio emergency services, Mensa, am writer, & published, started my own International Space Group http;//tech.groups.yahoo.com/group/MSpaceExpSIG/ Yes, that's me with the Apollo Astronauts. Everything was going fine.
Then the recent recall of Metotrexate injectables due to glass flakes from the vials. This is not the first time, several years ago got my injectable methotrexate from from Canada.
I do not need this gargage about the oral NSAIDS being just as good, not true. Now 23% less for Medicare Doctors? My main problem is this crazy medicao care. Has been right along, don't get me started on my battles with these HMO's regarding injectables before Medicare prescription drug plan kicked in. Don't think I did not get on Pres. Bush & others about that. In could write a book.
Everything was stable for a while. Though Obama care suppose to be better. Must I start fighting again? Is not the R.A. enough to fight alone in itself? Enough alresdy.
Two years later FDA stated it caused liver damage. Thought it was taken off the market? So this is new news? Ha!
Have been on the biologicals now over 10 years, no liver or serious joint damage since. Have to watch the methotrexate though, that can be the kidney ir liver problem causer, & that alone not nearly effective as with the biological modifiers.
I have used methorexate for 25 of the last 34 years. I was off it from 12/00 to 12/09 when I was using just Enbrel. I've returned to MTX.
Occasionally, I've had to stop MTX because of my liver. I take leucovarin for the nausea. MTX has several side effects. I've had oral lesions, nasal infections, diarrhea, and the "dreaded" Chemo Cough that comes with MTX. I feel fatigue for 36 hours after I inject myself with .4 ml.
I wonder if shortness of breath has more to do with limited movement of your ribs, or to arthritis' ability to attack soft tissue, such as your lungs. I've developed psoriatic arthritis, AS, and now osteopenia.
I have RSD, Osteoarthritis, Gout and a blood disorder called Cryoglobulinemia. My internist was giving me shots of Prednisone to get the gout under control, as I get it every 4 weeks. After a routine eye exam- I was told that I might have beginning stages of Glaucoma- as the doc saw some pressure in my eyes- the number was 24. Since I am a bit young for that problem, I suspected Prednisone and stopped getting the shots. 3 months later, at a eye pressure check up- the pressure was 21. Another 3 months later- it is now 17- NORMAL. Guess that tells the story.
Be aware that Prenisone not only can rob your bones of Calcium, and cause Osteoporosis if the doses are too high- it CAN also affect your eye pressure. If you have Diabetes- this can be VERY DANGEROUS ! Talk with your doctors about this ! prednisone works well- BUT does have risks- find out about them -and the proper doses to use if you MUST use this drug !
Be well- we are all in this boat together !
P.S Leflunomide had relieved my constipation, but with new info from FDA, considering going back to MX. My doctor prohibits any alcohol with MX - that is the hardest on me. I like my one glass of red wine at night.
In February my mail order drug provider changed me to a generic leflunomide and that's when my problems started.Every nite I'd get the worse backache;had all kinds of tests to see what was causing this pain,Nothing could be found.
All along I had been taking the leflunomide at nite so I had a hunch that the generic brand may have been causing the problem.My rhematologist pooh-poohed my thinking.So I decided to stop the medicine on my own,this past April 26,2010 and haven't had a back pain since.Yes,I've had RA flareups but nothing like the pain in my back.Now he wants me to go back on it..after reading this FDA warning...No Way.
The intense itching reported by Terry is interesting to me because I developed intense itching on my arms soon after beginning to take Arava.
Like Elsa Barrientez, I too worry about drug costs - I take 10 different medications in addition to paying for three additional medications for a bi-polar son. We now order our medications from Canada because even with insurance, the total co-pay was too expensive. The Canadian company has been very good and we have no complaints. You can find a list of approved Canadian pharmacies online. Check to see which ones carry your medication and how much each charges.
Today, 1.5 years later my feet are back to normal. Arava takes a lonnnnnng time to leave the body. This drug is a nightmare when it stops working and a dream when it does work; but the two scenarios go hand in hand unfortunately.
The damage was done and now 5 years later without taking Arava, the abscess's are back.
So, I would advise anyone to weight the pros and cons for any medications.
I am now on Enbrel and Prednisone.
Elsa Barrientez
elsabarrientez@sbcglobal.net
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