NEWS - Centocor warns of increased risk of lymhoma with Remicade

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CENTOCOR WARNS OF INCREASED RISK OF LYMPHOMA FOR PATIENTS TAKING

REMICADE

Oct 8, 2004

Faxwatch © 2004

Centocor Inc. sent a letter to health care professionals warning that

patients taking Remicade (infliximab) for rheumatoid arthritis were

approximately three times as likely to develop lymphoma than the general

public, according to the Associated Press.

Data from completed clinical trials for all patients taking the drug

revealed a six-fold increased risk of developing lymphoma.

The company has updated its label for Remicade, which is indicated to

treat rheumatoid arthritis and Crohn's disease, to reflect this lymphoma

risk. Centocor noted the label change is in line with warnings recently

added to other drugs in its class that act by blocking overproduction of

tumor necrosis factor, according to the AP.

Centocor also revised the Remicade label in August. At that time, the

company said some patients receiving Remicade have reported cases of

leukopenia, neutropenia, thrombocytopenia and pancytopenia.

Last week, the Food and Drug Administration approved a Remicade

(infliximab) regimen--a combination of Remicade and methotrexate--as a

first-line treatment for patients with rheumatoid arthritis. The

expanded label eliminates the requirement that patients must fail on

methotrexate treatment before they can start receiving the Remicade

regimen.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org