When the FDA approved the rheumatoid arthritis drug Arava in 1998, it noted that the new drug wasn’t any better than the existing treatments. But, they said, RA patients needed “some different options.”
Since then, about 200,000 people have taken the Arava “option.” At least 130 people have experienced severe liver toxicity, 56 have been hospitalized, and 12 have died. And an unlikely collection of organizations around the world have called for varying levels of action again this drug – from outright bans to carefully worded physician warnings.
Six times greater risk – but most doctors still unaware
Authorities note that many doctors are continuing to prescribe Arava – because most aren’t aware of the risks. In an Associated Press report on the issue, Dr. David Yokum said “I do not believe that the general rheumatologist understands or has any knowledge about these serious and potentially life threatening complications.” Yokum, a medical doctor now in private practice in Arizona, is a former scientific advisor to the FDA. Now, he’s joined forces with the consumer advocacy group Public Citizen in calling on the FDA to remove the drug from pharmacy shelves.
In a recent press release, the director of Public Citizen’s Health Research Group, Dr. Sidney Wolfe, compared the use of Arava (leflunomide) with the use of Rheumatrex (methotrexate), long considered the “gold standard” prescription drug treatment for rheumatoid arthritis. He found that the FDA had received SIX TIMES more reports of liver damage from Arava use as from Rheumatrex use – even though Rheumatrex is taken by thousands more people and has been in use much longer. And as Dr. Yokum noted, “it is impossible to predict which patients will be at risk.”
As if a former FDA scientist and Public Citizen aren’t strange enough bedfellows, there’s more. Early last year, the European Union warned patients and doctors about the drug. And in August, the mainstream even got in on the act: the American College of Rheumatology (ACR) issued a warning about Arava. While the ACR stopped short of calling for a ban, it did advise its member doctors that Arava “should be used with caution.”
Damage done in as little as three days
The ACR report also contains more specifics about the drug’s risks. In the known cases of serious side effects, most occurred in the first six months of treatment. (In some cases, problems surfaced in as little as three days, while in others, damage appeared after three years of treatment.) It also reported that the liver damage struck indiscriminately across age and gender lines.
But the ACR report does highlight some major risk factors. Most of the Arava users who suffered side effects had also been diagnosed with heart disease, diabetes, or hepatitis. And most were also taking another drug known to cause liver damage at the same time they were taking Arava. The ACR report makes special note of the concomitant use of Arava and nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen (Advil, Motrin), naproxen sodium (Aleve), celecoxib (Celebrex), and rofecoxib (Vioxx), and further warns patients not to drink alcohol while taking Arava.
The ACR also cautions against the experimental approach of combining Arava and Rheumatrex for the treatment of RA. Earlier research had shown that a combination of both drugs could be more effective than either alone. But a review of these negative reports shows that 30 percent of the patients who developed liver disease were taking both drugs at the same time.
And, Dr. Wolfe notes that liver damage isn’t Arava’s only problem. There have also been reports of lymphoma, high blood pressure, and a deadly auto-immune disorder associated with the drug.
Find relief for your RA pain AND protect yourself from dangerous side effects
If you have rheumatoid arthritis, and are currently taking or considering taking Arava, be sure to discuss these risks with your doctor. The ACR report recommends that RA patients have tests to measure the level of important liver enzymes called ALT before starting Arava therapy. Once on the drug, patients should have their ALT levels checked each month for the first six months, and if no problems develop, every two to three months afterward. If taking Arava and Rheumatrex together, the ACR calls for assessment of both ALT and another liver enzyme, AST.
But remember that prescription drugs aren’t your only option to treat RA. At HSI, we’ve written about many natural therapies for this debilitating disease. In the July 2001 issue, we told you how mycoplasma microbes can cause RA – and how they can be eradicated by a plant-based antimicrobial agent called Myco+. And in the February 2001 issue, we told you about Wobenzyme, a blend of pancreatic enzymes proven to reduce RA symptoms.
As a proponent of alternative health, I’m all for options. And I know how desperate rheumatoid arthritis patients can be for something, anything, that will relieve their pain. But you deserve to – and need to – know all the risks inherent in each of their alternatives before you make a decision.
Sources:
“Arthritis drug may cause liver damage” March 29, 2002 (AP) http://www.intelihealth.com
“Reports of leflunomide hepatotoxicity in patients with rheumatoid arthritis” American College of Rheumatology http:www.rheumatology.org
“Arthritis drug should be removed from market” March 28, 2002 http://www.citizen.org
Copyright 1997-2002 by Institute of Health Sciences, L.L.C.
