The prescription arthritis drug Arava, produced by Aventis and also known as leflunomide, has been used since 1998 to treat rheumatoid arthritis. The drug has been blamed for a high number of cases of severe liver problems and deaths. Consumer groups warn that the public is largely unaware of the serious and life-threatening complications potentially associated with use of Arava, and are asking that the drug be removed from the market.
In the past few years, Arava has been identified in numerous deaths and severe liver reactions. According to the United States Food and Drug Administration (FDA), Arava has been linked to approximately 130 cases of severe liver toxicity, 56 hospitilizations, and at least 12 deaths.
Various reports suggest that Avara is more fatal than the equally or more effective drug, methotrexate. According to one report, Arava was linked to six times more cases of fatal liver toxicity and 13 times more reports of hypertension than methotrexate, despite the fact that there were 6.8 million more prescriptions filled for methotrexate than Arava during that time.
Reports have also linked the drug to the life threatening autoimmune disease, Stevens-Johnson syndrome, whereas methotrexate has not. Yet another concern is that the drug could cause serious problems even after the patient discontinues use because drug byproducts can remain in body for months.
Dr. David Yocum of the Arizona Arthritis Center, who was recently chair of the FDA's Arthritis Drugs Advisory Committee, agreed Arava should be removed from the market. Yocum reported to the FDA a death of one of his patients from acute liver failure after using Arava. The European Agency for Evaluation of Medicinal Products has issued an urgent warning about the drugs' toxicity.
Arava side-effects include liver problems (elevated liver enzymes, yellowing of skin, blood in urine, etc.), hypertension (shortness of breath), blood disorders, high blood pressure, severe diarrhea and Stevens-Johnson syndrome.
2007-03-16 10:07:21
·
answer #1
·
answered by lynda 3
·
1⤊
0⤋
the tablets should have come with some paperwork to explain the side effects,if there are none speak with the pharmacist who dispensed them. hopefully they'll answer any questions, also your GP should be aware of the side effects from the last lot of tablets you were on and would have taken
this into consideration when prescribing the new ones.
hope things go well.
2007-03-16 08:54:20
·
answer #2
·
answered by stephen f 1
·
1⤊
0⤋
Here is the current uk prescribing information on it from bnf:
LEFLUNOMIDE
Indications:moderate to severe active rheumatoid arthritis; active psoriatic arthritis
Cautions:renal impairment (Appendix 3); impaired bone-marrow function including anaemia, leucopenia or thrombocytopenia (avoid if significant and due to causes other than rheumatoid arthritis); recent treatment with other hepatotoxic or myelotoxic disease-modifying antirheumatic drugs (avoid concomitant use); history of tuberculosis; exclude pregnancy before treatment; effective contraception essential during treatment and for at least 2 years after treatment in women and at least 3 months after treatment in men (plasma concentration monitoring required; waiting time before conception may be reduced with washout procedures—consult product literature and see Washout Procedure below); monitor full blood count (including differential white cell count and platelet count) before treatment and every 2 weeks for 6 months then every 8 weeks; monitor liver function—(see Hepatotoxicity below); monitor blood pressure; washout procedures recommended for serious adverse effects and before switching to other disease-modifying antirheumatic drugs
Hepatotoxicity:Potentially life-threatening hepatotoxicity reported usually in the first 6 months; monitor liver function before treatment and every 2 weeks for first 6 months then every 8 weeks. Discontinue treatment (and institute washout procedure—consult product literature and see Washout Procedure below) or reduce dose according to liver-function abnormality; if liver-function abnormality persists after dose reduction, discontinue treatment and institute washout procedure
Washout procedure:To aid drug elimination in case of serious adverse effect, or before starting another disease-modifying antirheumatic drug, or before conception (see also Appendix 4), stop treatment and give either colestyramine 8 g 3 times daily for 11 days or activated charcoal 50 g 4 times daily for 11 days; the concentration of the active metabolite after washout should be less than 20 micrograms/litre (measured on 2 occasions 14 days apart) in men or women before conception
Contra-indications:severe immunodeficiency; serious infection; hepatic impairment ; severe hypoproteinaemia; pregnancy (important teratogenic risk); breast-feeding
Side-effects: diarrhoea, nausea, vomiting, anorexia, oral mucosal disorders, abdominal pain, weight loss; increase in blood pressure; headache, dizziness, asthenia, paraesthesia; tenosynovitis; alopecia, eczema, dry skin, rash, pruritus; leucopenia; rarely taste disturbances, anxiety, tendon rupture, urticaria, anaemia, thrombocytopenia, eosinophilia, hyperlipidaemia, hypokalaemia, hypophosphataemia, hepatic dysfunction (see Hepatotoxicity above); also reported, pancreatitis, anaphylaxis, interstitial lung disease, severe infection, pancytopenia, vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (discontinue and initiate washout procedure—consult product literature)
Dose:Rheumatoid arthritis, adult over 18 years, initially 100 mg once daily for 3 days then maintenance, 10–20 mg once daily
Psoriatic arthritis, adult over 18 years, initially 100 mg once daily for 3 days then maintenance, 20 mg once daily
I hope this is helpful, dont be afraid to try the drug, some people get excellent results. Just be sure to attend for regular blood tests/monitoring as advised. Hope it works for you - any further questions just ask?
2007-03-17 04:03:19
·
answer #3
·
answered by mustlovedogs0 4
·
0⤊
0⤋