Arava -Liver Failure Lawyer - Arava Frequently Asked Questions

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 Frequently Asked Questions?

What is Arava?
When was Arava FDA approved?
What side effects are linked to Arava rheumatoid arthritis drug?
Is there a difference between Arava and competitor methotrexate to treat rheumatoid arthritis?
What is rheumatoid arthritis?
How many people does rheumatoid arthritis affect?
What is liver failure?
What is Stevens-Johnson syndrome?
Why has a petition been sent to the FDA to ban Arava?
Were there previous signs that Arava was associated to serious and potentially fatal adverse effects?
What are my legal rights regarding Arava side effects?

What is Arava?
Arava is a prescription drug for rheumatoid arthritis that has recently been linked to 130 cases of severe liver problems (hepatoxicity) and up to 22 deaths since it has been on the market. Arava is manufactured by Aventis Pharmaceuticals and is also known as leflunomide.

When was Arava FDA approved?
Arava was FDA approved in September 1998 and has so been used by more than 200,000 patients.

What side effects are linked to Arava rheumatoid arthritis drug?
Arava has been linked to life threatening conditions including, fatal liver failure, hypertension, and life-threatening autoimmune disease Stevens-Johnson syndrome. Arava is especially dangerous because it remains in the body tissues for an extended amount of time, allowing adverse effects to surface even after patients have discontinued their use of Arava.

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Is there a difference between Arava and competitor methotrexate to treat rheumatoid arthritis?
The FDA noted upon approval that Arava worked no better than methotrexate but it provided more options to patients. Sidney Wolfe, of the consumer advocacy group Public Citizen, compared the two arthritis drugs and found there have been six times more FDA reports of liver damage with Arava patients versus methotrexate patients. There have also been more FDA records of lymphoma, high blood pressure, and a life-threatening autoimmune disorder Stevens-Johnson syndrome in Arava patients than methotrexate patients. Despite numbers showing there have been 6.8 million more prescriptions filled for methotrexate than Arava, the number of adverse effects remains higher in lenflunomide users. Public Citizen has found the death rate is 33 times higher in Arava users.

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What is rheumatoid arthritis?
Rheumatoid arthritis (RA) involves inflammation in the lining of the joints and other internal organs. Unlike other types of arthritis that normally affects the elderly, rheumatoid arthritis' onset is between ages 25 and 50.

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How many people does rheumatoid arthritis affect?
About two million Americans suffer from rheumatoid arthritis, the majority of those affected being women and between the ages of 25-50.

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What is liver failure?
Liver failure, or hepatoxicity, can result from prescription drug use and occurs when a large part of the liver has become damaged beyond repair. Arava has been linked to at least 12 deaths due to liver failure amongst other serious liver problems.

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What is Stevens-Johnson syndrome?
Stevens Johnson Syndrome is an extreme allergic reaction, usually to a drug, and has been associated to the rheumatoid arthritis drug Arava. This autoimmune disease often leads to severe morbidity and death.

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Why has a petition been sent to the FDA to ban Arava?
The U.S. consumer advocacy group Public Citizen urged regulators to immediately ban rheumatoid arthritis drug Arava (leflunomide) because of the link between the prescription drug and 12 fatal cases of liver failure. Public Citizen said that the risks of Arava outweigh its benefits.

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Were there previous signs that Arava was associated to serious and potentially fatal adverse effects?
In February 2001, the European Agency for the Evaluation of Medical Products issued a warning to doctors and patients citing nine deaths due to liver failure in Arava patients. Two months after that, Arava manufacturer Aventis Pharmaceuticals issued a warning letter to physicians. Last August, the American College of Rheumatology published a warning to doctors and patients urging monthly blood tests be taken in an Arava patient's first six months and follow-up tests every two to three months following. If you have suffered from the use of prescription drug Arava, contact us to learn your rights.

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What are my legal rights regarding Arava side effects?
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.

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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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