March 6, 2003 WASHINGTON (AP) -- A rheumatoid arthritis treatment under attack for possibly causing deadly liver failure actually is an important option that should continue to be sold, government advisers decided Wednesday.
The drug, called Arava, already comes with warnings about side effects -- including the need to have liver tests -- and no further restrictions seem warranted, advisers to the Food and Drug Administration concluded.
Arava in 1998 became the first new treatment option in years for people with rheumatoid arthritis.
This is not the wear-and-tear joint damage that affects the elderly. Instead, the immune system goes awry and destroys patients' own joint tissue at a young age.
Standard treatment is a cancer drug called methotrexate. Arava works equally well, the FDA says. It comes with warnings that doctors must check Arava patients regularly for signs of liver damage, and that women must use birth control because Arava can cause birth defects.
But the consumer advocacy group Public Citizen has petitioned the FDA to ban Arava, saying users of the newer drug have proved six times more likely to suffer liver failure than methotrexate patients.
Reaction within FDA is mixed. An analysis by one FDA office recommended a ban, citing 54 U.S. cases of liver failure or damage -- including eight deaths -- linked to the drug, and additional reports from overseas. The analysis also studied health insurance databases to note that few Arava users stick with that drug for longer than five months.
But other FDA officials told the advisory panel Wednesday that they agree with manufacturer Aventis Pharmaceuticals that there is no proof Arava is more dangerous than several competing treatments.
The advisory panel ultimately unanimously agreed that Arava's risks do not outweigh its potential benefits to patients. Panelists cited several studies of the drug -- instead of the harder-to-investigate injury and death reports that critics point to -- in saying Arava does not seem to warrant stronger warnings than it currently bears, said the FDA's Dr. Sandra Kweder.
The FDA is not bound by its advisers' recommendations, but typically follows them.
Copyright 2003 The Associated Press. All rights reserved.
