Observations placeholder
Leflunomide and Arava
Identifier
017727
Type of Spiritual Experience
Background
Benefit-risk assessment of leflunomide: an appraisal of leflunomide in rheumatoid arthritis 10 years after licensing - Alcorn N, Saunders S, Madhok R; The Centre for Rheumatic Diseases, Glasgow Royal Infirmary, Glasgow, UK [edited for brevity].
.... Leflunomide was licensed for the treatment of rheumatoid arthritis in 1998. Postmarketing surveillance, case reports and observational studies have highlighted less common or unexpected adverse events. Therefore, it is appropriate that we review the benefit-risk profile of leflunomide after 10 years of widespread usage. A wide-based search of relevant literature was performed to formulate this assessment.
The improvements in rheumatoid arthritis shown by double-blind, randomized controlled trials (RCTs) of leflunomide have now been shown to be maintained beyond 4 years in open-label extension studies. Leflunomide is comparable to methotrexate, but better than sulfasalazine at 24 months in only one study. However, tolerance in clinical practice research shows higher than expected withdrawal rates due to both toxicity and lack of efficacy when compared with methotrexate and placebo. Adverse events reported include gastrointestinal upset, hypertension, headache, hepatotoxicity and hair loss, as well as predisposition to infection and peripheral neuropathy. The incidence of gastrointestinal adverse effects for leflunomide is similar to sulfasalazine but higher than those seen with methotrexate. Serious drug-induced hepatotoxicity leading to hospitalization is rare (0.02%), but isolated fatalities from liver failure have been documented. It is considered likely, but not yet proven, that there may be an increased incidence of weight loss and interstitial lung disease with leflunomide. …. …
Leflunomide is an effective DMARD that sustains a clinical and radiological response comparable to sulfasalazine and methotrexate. However, adverse effects necessitate frequent monitoring. It should be used with caution in those of child-bearing potential and with pre-existing lung and liver disease.
A description of the experience
Leflunomide brand name Arava is used in active moderate to severe rheumatoid arthritis and psoriatic arthritis. It is a pyrimidine synthesis inhibitor.
Leflunomide is metabolized to teriflunomide, which is responsible for all of the drug's activity in vivo. It is very slow to act and takes a long time to clear from the body. The onset of clinical improvement can be expected after 4 to 6 weeks of continued therapy, peak plasma levels of teriflunomide occur between 6 and 12 hours after dosing and it has a very long half-life - approximately 2 weeks. This means that it is often difficult to get the dose right. The following side effects have been noted:
- Cancer - Due to its potent immunosuppression, leflunomide has the potential to promote myeloid/lymphatic malignancies or solid cancers. In postmarketing reports some cases of lymphoma have been noticed.
- Liver damage - The most serious side effect is symptomatic liver damage ranging from jaundice to hepatitis. Fatalities are known. The EMEA, has in 2001 reported 296 cases of hepatotoxicity in 104,000 patient years, with 129 considered as serious, 2 cases of liver cirrhosis, and 15 cases of liver failure. Nine of the patients died. The concomitant use of methotrexate may lead to severe or even fatal liver- or hepatotoxicity. Seventy-five percent of all cases of severe liver damage reported until early 2001 were seen under combined drug therapy Arava plus methotrexate.
- Myelosuppression - with leukopenia, and/or hypoplastic anemia, and/or thrombocytopenia
- Infections - sometimes as severe as development of active tuberculosis, pneumonia, PCP, and severe viral or mycotical infections, possibly leading to sepsis, death or permanent damage have been seen.
- Interstitial lung disease which may not be reversible upon treatment and may lead to permanent disability or death.
- skin reactions up to life-threatening forms
On Jan, 13, 2017 22,860 people reported to have side effects when taking Arava. Among them, 49 people (0.21%) have Hallucination
Time on Arava when people have Hallucination :
| < 1 month | 1 - 6 months | 6 - 12 months | 1 - 2 years | 2 - 5 years | 5 - 10 years | 10+ years | |
| Hallucination | 44.44% | 48.15% | 0.00% | 7.41% | 0.00% | 0.00% | 0.00% |
Gender of people who have Hallucination when taking Arava :
| Female | Male | |
| Hallucination | 50.00% | 50.00% |
Age of people who have Hallucination when taking Arava :
| 0-1 | 2-9 | 10-19 | 20-29 | 30-39 | 40-49 | 50-59 | 60+ | |
| Hallucination | 0.00% | 0.00% | 0.00% | 5.88% | 2.94% | 8.82% | 38.24% | 44.12% |
On Jan, 22, 2017 13,872 people reported to have side effects when taking Leflunomide. Among them, 11 people (0.08%) have Hallucination
Time on Leflunomide when people have Hallucination :
| < 1 month | 1 - 6 months | 6 - 12 months | 1 - 2 years | 2 - 5 years | 5 - 10 years | 10+ years | |
| Hallucination | 100.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |