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

Arava (leflunomide) is an anti-inflammatory medicine that is used to treat the signs and symptoms of rheumatoid arthritis. Arava is in the FDA pregnancy category X because of the increased risk of birth defects and fetal death while taking the rheumatoid arthritis drug. The drug should not be taken if the patient is or is planning on becoming pregnant. 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. It is not known whether or not Arava passes through breast milk, so safety precautions should be taken.

Who should not take Arava (leflunomide)?

There is alternate rheumatoid arthritis medication that does not carry the same risk that Arava has been linked to. When the FDA approved Arava they did not find that the drug produced better results, rather the entrance of the RA drug would provide patients with more options. Methotrexate has been identified to have six times less occurrence of reported liver damage than Arava, even despite methotrexate being prescribed 5.5 times more. Sidney Wolfe, of the Public Citizen consumer advocacy group believes that "when there are other treatments that are more effective and don't endanger patients as much as this drug, there is absolutely no reason for the FDA to keep Arava on the market." The consumer advocacy group petitioned to the FDA for the immediate ban of Arava on March 28, 2001.

Before taking Arava (leflunomide) it is advised to tell your doctor if you have:

  • liver disease, history of hepatitis
  • history of a lot of alcohol use
  • kidney disease
  • have recently received a live vaccine
  • chronic infection
  • immune system disease
  • poor bone marrow function

In addition, if any of the following drugs are being used, it is also advised to seek medical opinion concerning Arava because combining certain drugs may increase risk of deadly side effects.

  • cholestyramine (Questran, Prevalite, LoCholest)
  • methotrexate (Rheumatrex)
  • rifampin (Rifadin, Rimactane)

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.

 

FAQ's

What is Arava?

When was Arava FDA approved?

What side effects are linked to Arava rheumatoid arthritis drug?

What is rheumatoid arthritis?

How many people does rheumatoid arthritis affect?

What is liver failure?

What is Stevens-Johnson syndrome?

What are my legal rights regarding Arava side effects?


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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