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. |
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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. |
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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 » |
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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 Legal InformationAventis Pharmaceuticals, Arava manufacturer, issued a warning letter to doctors after the Agency for the Evaluation of Medical Products in Europe warned that Arava can cause liver damage in February 2001. The pharmaceutical company failed to warn U.S. physicians and patients until two months later. The following August, the American College of Rheumatology published a warning to doctors and patients urging monthly blood tests in a patient's first six months on the drug and follow up tests every two to three months after that. A doctor at the Arizona Health Sciences Center, Dr. David Yocum, thinks that it is impossible to predict which patients will be at risk because there is not much a doctor can do if a patient shows signs of trouble. Yocum stated that, "I do not believe that the general rheumatologist understands or has any knowledge about these serious and potentially life-threatening complications," (AP, 3/28/02). Arava has now been linked to at least 130 cases of severe liver damage and liver toxicity, with 12 of these cases resulting in death.
The FDA did not find Arava to be any more effective but said approving Arava would provide more patient treatment options for rheumatoid arthritis sufferers. 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." Arava is associated with six times more cases of fatal liver damage then methotrexate is, even though methotrexate is used more widely as well as having a 33 times higher death rate.
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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:
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