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Arava -- Further Negative Information

 


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Dosing and Administration

  • Dose may be decreased to 10 mg daily if tolerability issues arise
  • Doses higher than 20 mg daily are not recommended
  • Liver enzymes should be monitored and dose adjustments may be necessary. For confirmed elevations

      - >2-fold ULN, reduce dose to 10 mg/day
      - >2- but <3-fold ULN despite dose reduction, biopsy liver if continued treatment is desired
      - >3-fold ULN despite cholestyramine administration (8g tid x 1 day) and dose reduction, discontinue Arava and readminister cholestyramine

    Observe carefully after dose reduction; may take several weeks for metabolite levels to decline due to half-life

  • Arava can be taken without regard to meals
  • Arava can be administered to the following patients:

      - Patients >65 years of age (no dosage adjustment required)
      - Patients receiving concomitant NSAIDs and/or low-dose corticosteroids


 


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ARAVA LAWYER - RELATED INJURIES MAY INCLUDE LIVER TOXICITY, LIVER FAILURE, HYPERTENSION, STEVENS-JOHNSON SYNDROME & DEATH TO SOME ARTHRITIS USERS. FDA IS INVESTIGATING

ARAVA® LAWYER LEGAL ACTIONS - ARAVA® RELATED INJURIES MAY INCLUDE LIVER TOXICITY, LIVER FAILURE, HYPERTENSION, ELEVATED LIVER ENZYMES, LYMPHOMA, BLOOD DISORDERS, STEVENS-JOHNSON SYNDROME & EVEN DEATH TO SOME ARAVA USERS.

 

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ARAVA & LIVER FAILURE

U.S. group seeks ban of Aventis arthritis drug Arava

Thursday March 28, 2002

By Lisa Richwine

WASHINGTON, March 28 (Reuters) - A U.S. consumer group on Thursday urged regulators to immediately ban Aventis  rheumatoid arthritis drug Arava, 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 said in a petition to the Food and Drug Administration (FDA).

From September 1998, when Arava debuted in the United States, to September 2001, the FDA received 130 reports of severe liver reactions in patients taking Arava, Public Citizen said. For 12 cases that were fatal, liver damage from Arava ``appears to be the most plausible explanation,'' the group said.  Officials at Aventis, which reported worldwide sales of 258 million euros ($225 million) for Avara 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 was less or equally effective as 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.  ``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. David 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, although he was uncertain if 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.  An FDA spokesman said the agency would review the petition carefully.  Arava is known generically as leflunomide.

 

 


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