A popular rheumatoid arthritis drug has been ordered by the FDA to carry a black boxed warning – specifically for people with liver disease.
All drugs have side effects, but Arava appears to have more than its fair share. With numerous reports of liver damage and a good percentage of related deaths, the rheumatoid arthritis drug Arava is now required to carry a black boxed warning, the most stringent warning the Federal Drug Administration (FDA) can require a drug to carry. While the warning in question applies to people with liver disease, there is also great concern for the thousands of people who have not yet been formally diagnosed with chronic liver disease.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disorder that typically affects the small joints in the hands and feet. RA is different from osteoarthritis, the most common kind of arthritis, because it is an autoimmune disease. In an autoimmune disorder, the immune system mistakenly attacks the body’s own tissues. Below are several facts about RA:
· RA can affect the entire body with fevers and fatigue.
· RA is two to three times more common in women than in men and generally occurs between the ages of 40 and 60.
· There is no cure for RA, but treatment options have expanded greatly in the past few decades.
· Although there is likely a genetic tendency, physicians don’t know what triggers RA.
· Each year, RA is estimated to affect 70 out of 100,000 people in the U.S.
· The immune system of those with RA attacks the lining of the membranes that surround the joints, causing inflammation, membrane thickening, pain and joint misalignment.
To prevent or delay the chronic pain and deformity typical of RA, many medications might be considered. Of the more successful medications used to manage RA are disease-modifying anti-rheumatic drugs (DMARDs). DMARDs are known to slow the progression of RA and save the joints and other tissues from permanent damage.
Approved by the FDA in 1998, Arava (leflunomide) is a DMARD that helps improve RA symptoms, such as joint swelling and tenderness. Unlike many other drugs used for RA pain and swelling relief, Arava actually helps slow the progression of RA joint damage. In addition, Arava is the only oral DMARD indicated to improve physical function. Unfortunately, those with liver disease are no longer candidates for Arava therapy. On July 13, 2010, the FDA released a statement that Arava is now required to carry the strictest possible warning for potential harm:
· The medication already had a bolded warning on the label since 2003 alerting patients and doctors to possible liver injury from Arava.
· The FDA has determined that this previous warning was not strong enough and has now required it be placed in a black box on the label with additional prescribing information.
· The FDA is recommending that patients with pre-existing liver disease, or with elevated liver enzymes, not be given Arava.
· The warning also suggests that doctors monitor the liver enzymes of patients on Arava monthly for at least three months after they start the drug, and at least quarterly after the first three months.
· If liver enzymes climb to more than twice the upper limit of what’s considered within the normal range, the patient should be taken off Arava and given cholestryamine to speed up the drug’s removal from the body.
· Patients who develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stool while taking leflunomide should contact a healthcare professional.
Liver Disease Prevalence
Millions of Americans are currently diagnosed with some form of liver disease, and millions more don’t know it. Some of the more prominent causes of chronic liver disease include Hepatitis C, fatty liver disease and alcoholism. Of those three, an estimated five million Americans have Hepatitis C, two million have alcoholic liver disease and a quarter of American adults are believed to have fatty liver disease. These numbers are especially staggering when the possibility of so many people being unaware of their liver’s vulnerability is realized.
When putting this entire picture together, it is highly likely that people receiving treatment for RA have a coexisting liver condition. This proactive step mandated by the FDA should persuade all people taking the RA medication, Arava, to make sure they are not affected by this new black box warning. Those taking Arava with liver disease are encouraged to take immediate action. In addition, those taking Arava who have not been evaluated for liver disease are advised to consult with their physician and request a screening of their liver health.
http://arthritis.about.com/od/arava/Arava_Leflunomide_Dosage_Side_Effects_Interactions_Warnings.htm, Arava - Leflunomide - Dosage - Side Effects - Interactions – Warnings, Retrieved July 18, 2010, about.com, 2010.
http://www.aboutlawsuits.com/arava-liver-damage-side-effects-black-box-11421/, Arava Liver Damage Side Effects Added to Black Box Warning, Retrieved July 18, 2010, AboutLawsuits.com, 2010.
http://www.arava.com/hcp/default.aspx, Arava Inhibits Progression of Joint Damage, Retrieved July 18, 2010, sanofi-aventis U.S. LLC, 2010.
http://www.hopkins-arthritis.org/arthritis-info/rheumatoid-arthritis/rheum_clin_pres.html, Rheumatoid Arthritis Clinical Presentation, Alan K. Matsumoto, MD, Retrieved July 18, 2010, The Johns Hopkins University School of Medicine and the Johns Hopkins Arthritis Center, 2010.
http://www.mayoclinic.com/health/rheumatoid-arthritis/DS00020, Rheumatoid Arthritis, Retrieved July 18, 2010, Mayo Foundation for Medical Education and Research, 2010.
http://www.medpagetoday.com/ProductAlert/Prescriptions/21145, FDA Adds Liver Failure Warning to RA Drug, Cole Petrochko, Retrieved July 18, 2010, MedPage Today, LLC, 2010.
http://www.wrongdiagnosis.com/a/alcoholic_liver_disease/prevalence.htm#prevalence_intro, Prevalence of Alcoholic Liver Disease, Retrieved July 18, 2010, Health Grades Inc., 2010.