I have been having pains on my right side under my rib cage. Thought it may be my gall bladder or liver. I went in Monday for my regular blood work (every 2 months) due to being on Arava and my RD's office called the next day and told me to stop taking the Arava because my liver enzymes were elevated. Told her I had been having pains for the last 3-4 days, she said you'll need to call your PCP for that. I went on Wednesday and my PCP took more blood and scheduled a sonogram for the 1st of May. My liver enzymes are still elevated. Dateline: March 15, 2001
The EMEA (European Medicines Evaluation Agency) issued a public statement on March 12, 2001 regarding Arava (generic name leflunomide) and serious hepatic reactions. Arava (leflunomide), classified as a DMARD (disease-modifying anti-rheumatic drug) is indicated for patients with active rheumatoid arthritis. When the FDA (U.S. Food and Drug Administration) approved Arava in September 1998, it was heralded as the first new treatment for rheumatoid arthritis in 10 years. The European Union followed with its approval of the drug in September 1999. Approximately 200,000 people have used Arava since it became available.
The statement from the EMEA revealed a total of 296 adverse reports of hepatic (liver) reactions, of which 129 were considered serious. Included were 2 cases of liver cirrhosis and 15 cases of liver failure, of which 9 were fatal. The reported hepatic reactions occurred within six months of when treatment had been started. The EMEA report emphasizes that "confounding factors" existed in many of the cases. Of the reported adverse reactions:
The EMEA statement points out that in these cases, liver function tests may not have been properly monitored and washout procedures (procedures to clear the drug from the body) may not have been followed.
Due to the serious nature of these adverse reports, the EMEA offered the following recommendations:
The washout procedure consists of 8 g. cholestyramine (3 times daily) or 50 g. activated powdered charcoal (4 times daily). Usually a complete washout takes 11 days. The EMEA has also added information to the Arava package insert which advises patients to inform their doctor immediately of symptoms which may be indicative of a developing liver disorder, including:
The FDA, upon review of the adverse reports, will decide if any action is necessary in the United States.
Has anyone had liver problems due to taking Arava?
Blessed,
EMEA Issues Public Statement
Please let us know what happens.
Blessed,
Yes, I had a severe reaction to Arava that resulted in an inflamed liver, jaundice and loss of my immune system (stopped making red and white blood cells). Problem was verified by a liver biopsy and had to go through the "cleanse" to remove the drug from my system. I'm fine today, but it took a while to get the bone marrow to start working again.
Marianne
I had problems on MTX. After tseting perfect for more than 5 years I suddenly started testing high. WE reduced my MTX and that didn't help so we eventually stopped it all together and it got better. I had the sonogram too and the next step was a biopsy; but it got better.
It might be your gall bladder. I don't think you'd have pain from elevated ALT & AST figures. Chances are the pain is coming from something else entirelly.
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