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 News

- March 29, 2002
Rheumatoid arthritis drug Arava (leflunomide) is linked to at least 12 liver failure deaths.
Public Citizen filed a petition to the FDA urging them to review the unexpected deaths and serious illnesses that have been attributed to the use of Arava (leflunomide). Former FDA scientific adviser Dr. David Yocum supports Public Citizen's petition because "here we have 12 deaths, and these patients died very quickly. All I can say is, this needs to be reviewed."

Public Citizen's petition followed the February 2001 European Agency for the Evaluation of Medical Products warning issued to doctors and patients citing nine liver failure deaths in Arava patients. Two months following, Arava manufacturer Aventis Pharmaceuticals issued a warning letter to physicians. Last August, the American College of Rheumatology then published a warning to doctors and patients urging a monthly blood test be performed in an Arava patient's first six months with follow up tests every two to three months after. Yocum said he has never supported taking a drug off the market, "but it's kind of scary, what we see." (MSNBC, 3-29-02)

- March 28, 2002
Public Citizen asks FDA to immediately ban Arava.
Consumer advocacy group Public Citizen urged regulators to immediately ban Aventis' rheumatoid arthritis drug Arava (leflunomide) due to the link to 12 fatal cases of liver failure. Public Citizen finds the risks of Arava to outweigh its benefits that have proven to be no more effective or beneficial than older, commonly used treatments.

The FDA has received 130 reports of severe liver problems in Arava patients since the drug's 1998 U.S. debut. Reports of lymphoma and drug induced hypertension in Arava patients, as well as blood and gastrointestinal reactions leading to hospitalizations have been found, according to Public Citizen. Director of Arizona Arthritis Center and former scientific adviser to the FDA, Dr. David Yocum, also agrees that Arava should be pulled from the market. Yocum has treated a patient on Arava that died from liver failure, and he finds Public Citizen's data to be "idiosyncratic and unpredictable".

The resulting deaths and serious Arava side effects associated to the rheumatoid arthritis drug appears to have had warning that may have prevented these incidents from occurring. In February 2001, the European Medicines Evaluation Agency warned of severe liver reactions with some fatal outcomes occurring in Arava patients. 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. (Reuters, 3-28-02)

- 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)

 

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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