Arava - An Improved Drug?
A recent study has found that only 15% of new drugs approved in the last decade were novel chemicals that the FDA deemed a significant improvement over older drugs. It is not just Arava liver failure that is the concern, but of lymphoma, hypertension, and other problems have also been reported.

Dangers of Arava

Arava is dangerous, not just because of the life threatening and serious Arava side effects associated to the rheumatoid arthritis drug, but because the inability to predicts which patients are at risk and the short amount of time it takes for the drug to affect someone. In six months Arava patients have suffered from the dangerous side effects associated to the drug and even when discontinuing the rheumatoid arthritis drug treatment patients are still at risk because it remains within the body as it slowly dissipates. Rheumatoid arthritis affects around 2 million Americans, typically affecting adults between the ages of 25-50.

If you have taken Arava and would like more information due to the serious Arava side effects that you have, or still are, experiencing, please CONTACT US to learn more.


About Arava

Arava is especially dangerous due to the amount of time the drug remains in the body after discontinuing its use, so the risk of harming an unborn baby can still be great. click here to read more »


Arava Legal     Information

A recent study has found that only 15% of new drugs approved in the last decade were novel chemicals that the FDA deemed a significant improvement over older drugs. click here to read more »






 

 

Arava - Liver Failure

More than two million Americans are affected by rheumatoid arthritis (RA), normally first affecting individuals between the ages of 25-30 when their immune system begins to attack their cartilage. In the past, methotrexate was used to treat rheumatoid arthritis patients until the FDA approved Arava (leflunomide), manufactured by Aventis Pharmaceuticals in September 1998. Since then, the FDA has received 130 reports of severe Arava liver toxicity that includes 56 hospitalizations and 12 deaths. The Public Citizen consumer group filed a petition on March 28, 2002 for the FDA to immediately ban Arava from the market. Public Citizen is proactive in questioning FDA action regarding pharmaceutical drugs and questions why Arava was approved by the FDA simply to provide different options for patients but showed no signs of working better than already available treatments such as methotrexate. In addition, Arava has been found to have six times more FDA reports of liver damage than methotrexate. The two rheumatoid arthritis drugs work equally well, so Public Citizen wants Arava's sales banned. The FDA is still reviewing Public Citizen's petition.

If you have taken Arava and would like more information due to the serious Arava side effects that you have, or still are, experiencing, please contact us to learn more.

Message from Public Citizen
Public Citizen's Dr. Sidney Wolfe said Arava should never have been approved because the drug's studies showed it contributed to elevated liver enzymes, which is normally a sign of damage to the organs.

   Arava Side Effects

   Arava was originally considered
   to be a safer alternative to    methotrexate, the commonly used    rheumatoid arthritis drug used
   prior to Arava's approval.    Methotrexate has been known    for its severe side effects, but
   Arava has now been shown to have a death rate of 33 times higher than methotrexate patients and has had six times more reports of liver damage. These Arava figures do not even take in consideration the fact that methotrexate has been prescribed 5.5 times more than Arava. More than 200,000 rheumatoid arthritis patients have used Arava since the drug was released. Arava did not receive approval because of its superiority in treating rheumatoid arthritis over methotrexate but simply because the FDA wanted RA patients to have more treatment options. click here to read more »

Arava linked to 12 deaths

Public Citizen filed a petition to the FDA asking the agency to review the unforeseen deaths and illnesses that have been associated to Arava on March 28, 2002. The 12 deaths that have been linked to Arava are from liver failure, as well as dozens of other serious illnesses. Some doctors claimed they would continue to prescribe the prescription drug intended to treat the signs and symptoms of rheumatoid arthritis (RA) but alongside blood tests to monitor patients' liver function. Other doctors supports Public Citizen's petition, including the former scientific adviser to the FDA and current director of the University of Arizona Arthritis Center Dr. David Yocum, in particular because of the rapid deaths of the 12 Arava patients.

The first warning that Arava was linked to liver failure was in February 2001 when the European Agency for the Evaluation of Medical Products issued a warning to doctors and patients. The agency cited nine deaths that had occurred from liver failure in Arava patients. Arava's manufacturer, Aventis Pharmaceuticals, issued letters to physicians following the agency's warning throughout Europe but did not warn the U.S. physicians and patients for another two months.

Arava was developed as an alternate medication for rheumatoid arthritis. Methotrexate had been the predominant rheumatoid arthritis medication until the approval of Arava. The FDA approved Arava in 1998 but said it was no better than methotrexate but Arava would allow patients to have options. Dr. Yocum has worked on arthritis drug development for almost 20 years and has never supported taking a drug off the market until Arava.

If you have taken Arava and would like more information due to the serious Arava side effects that you have, or still are, experiencing, please
CONTACT US to learn more.

Arava In the News

-March 28, 2002
Rheumatoid arthritis drug Arava may cause liver damage.
Public Citizen wants rheumatoid arthritis drug Arava banned because of the dozens of serious liver injuries and 12 deaths linked to the drug's use. After the 1998 FDA approval, the FDA did state that Arava worked no better than the older drug, competitor methotrexate, but it know provided patients with different options. The FDA has now received at least 130 reports of severe liver toxicity linked to Arava use, and this includes 56 hospitalizations and 12 deaths. The FDA has six times more reports of liver damage among Arava users than methotrexate users, despite methotrexate being prescribed 5.5 times more than Arava. (Yahoo, 3-28-02) click here for more news »

Arava can cause stevens johnson syndrome learn more...

 

FAQ's

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Arava        Violations
October 23, 1998

Arava (leflunomide) manufacturer was sent a letter from the Department of Health and Human Services notifying them that The Division of Drug Marketing, Advertising and Communications reviewed their submissions and found they had violated the Federal Food, Drug, and Cosmetic Act. The FDA had identified violations in the following Arava materials:

  • New Release (ID#98190106/
    2934P8)
  • Media Alert (ID#98190105/
    2933P8)
  • Dear Editor/Producer
    Letter (ID#98190101/
    2930P8)
  • Video with Script (ID#98181101/
    2887P8)
These FDA violations of Arava materials led the Division of Drug Marketing, Advertising and Communications to recommend that Arava manufacturer take the following actions:

1. Immediately discontinue the use of this, and all other promotional materials for this product that contain the same or similar violations.
2. Provide to DDMAC, in writing, HMR's intent to comply with #1 above. Your response should be received by November 6, 1998.
3. This response should include a list of all similarly violative promotional materials and HMR's method for discontinuing their use.

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