Increasing reports of major side effects - cancer and liver failure - are spurring the government to take a second look at the safety of rheumatoid arthritis drugs that gave patients unprecedented hope when they began hitting the market four years ago.
"These drugs have shown tremendous benefit, but they ... all have pros and cons," said Dr. Karen Weiss of the Food and Drug Administration.
Of the 2 million rheumatoid arthritis sufferers, thousands try one of the four drugs each year. Tuesday, the FDA's scientific advisers began two days of debate over how big a risk each medication poses and whether stronger warnings or restrictions are needed.
The consumer advocacy group Public Citizen is pushing for one of the medicines, Arava, to be banned. Reaction within FDA is mixed. An agency analysis posted on the FDA's Web site Tuesday recommends a ban - citing 54 U.S. cases of liver failure or damage and eight deaths linked to the drug.
"People should not use this," said Public Citizen's Dr. Sidney Wolfe, who contends Arava is far riskier than an equally effective, older alternative.
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Developed by Aventis Pharmaceuticals. Arava is used in the treatment of rheumatoid arthritis, to inhibit structural damage to joints. Arava was approved by the FDA in September 1998, despite the fact that Arava did not treat rheumatoid arthritis better than similar products on the market. Serious Side Effects of Arava: Arava has been associated with six times as many reports of liver damage, more reports of lymphoma, high blood pressure, and Steven-Johnson syndrome. The death rate of Arava users is significantly higher than most other rheumatoid medications.
Arava has shown serious side effects that have been linked to over 20 deaths in addition to 100+ cases of liver problems. Numerous suits have been filed. |
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