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Biotech / Medical : Vertex Pharmaceuticals (VRTX) -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (488)	3/16/2001 1:32:12 AM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 1169

Hurry up Aventis, with ICE. Before J start playing basketball more often. European Regulators Warn of Severe Hepatic Reactions With New Arthritis Drug -------------------------------------------------------------------------------- LONDON (Reuters Health) Mar 14 - Severe liver injuries, some with a fatal outcome, have occurred in patients treated with Aventis' novel rheumatoid arthritis drug leflunomide (Arava), the European Medicines Evaluation Agency (EMEA) said. In a public statement on its web site, the agency said a total of 296 cases of hepatic reactions had been reported. "Of these, 129 cases were considered as serious, including 2 cases of liver cirrhosis and 15 cases of liver failure, 9 with a fatal outcome." The statement, dated March 12, said that most adverse events occurred within 6 months of starting therapy. "Although confounding factors were present in many cases, a causal relationship to leflunomide cannot be excluded." Arava, a disease-modifying antirheumatic drug, is the first new treatment for rheumatoid arthritis in more than 10 years. It has been available from hospital specialists since 1999 for the treatment of adults with active disease. The EMEA said that in view of the seriousness of the reactions it wished to point out that the drug is contraindicated in patients with impaired liver function. It added that concomitant treatment with methotrexate and other hepatotoxic medications was associated with an increased risk of serious hepatic reactions and was not advisable. "It is considered essential that monitoring recommendations are strictly adhered to," the statement added. A spokesman for Aventis told Reuters Health that the firm is sending out a "Dear Doctor" letter and re-enforcing the drug's labeling about liver injury in the EU. In the United States, talks were underway with the FDA to determine whether any steps were necessary. The Aventis spokesman said that 200,000 patients had used the drug since it was launched in the US in September 1998 and in the EU in September 1999. He stressed that a causal relationship between the drug and liver injury has not been established. "We are confident that in most patients these rare reports do not in anyway alter the benefit-risk profile." The new labeling stipulates that ALT liver function must be checked before therapy is started, at least monthly during the first 6 months of treatment, and every 8 weeks thereafter. For ALT elevations between two and three times the normal upper limit, the drug dose can be reduced from 20mg to 10mg and monitoring should be performed weekly. If ALT elevations of more than twice the normal upper limit persist, or if ALT increases to more than three times the upper limit of normal, leflunomide must be stopped and wash-out procedures started. The EMEA public statement makes clear that 78% (101 patients) experiencing serious reactions were also taking hepatotoxic medications. "In addition, in 33 of these serious cases other risk factors were reported including a history of alcohol abuse and liver function disturbance." "Preliminary data on the prescribing profile of leflunomide suggest that monitoring of liver function tests and wash-out procedures might not have been fully adhered to," the statement noted.