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 Patient Action

Reporting Arava Adverse Effects to the FDA

MedWatch is the FDA's program that allows consumer to report serious reactions and problems with medical products. So far, there have been at least 130 cases of severe liver problems (hepatoxicity) and 22 deaths since Arava's arrival to the market in 1998. It is estimated that there is a 10-100 fold of underreporting that occurs with a drug's adverse effects. Not reporting serious adverse Arava side effects can result in continued instances of death and serious health conditions that may have been prevented. Since MedWatch is a voluntary reporting system, many healthcare providers, as well as individuals, fail to give this information to the FDA. If you, or a family member, have suffered the serious and potentially deadly Arava side effects, it is encouraged for you to report it, and there are several different reporting options available.

» Your health care provider or the FDA online reporting form that allows consumers to notify the FDA of important and useful information regarding patient safety. 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. You may be eligible to file a claim for the injuries and serious Arava side effects you have sustained as a result of the rheumatoid arthritis drug that has been linked to cases of liver failure and other conditions.


 

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.

top of page
 
About Arava | Arava Side Effects | Arava Legal Information | Arava News | Arava Patients Action | Contact Us | Arava Lawyer