Oct. 8, 2004
Yahoo News
NEW YORK (Reuters) - Johnson & Johnson is warning doctors that patients taking its rheumatoid arthritis drug Remicade may have a higher risk of lymphoma, a blood cancer, the company said on Friday.
The warning will be added to the drug's package insert and means the drug's safety profile will more closely match that of rival drugs in the same class, Amgen Inc.'s Enbrel and Abbott Laboratories Inc.'s Humira.
The label will warn of a three-fold increase in the risk for rheumatoid arthritis patients taking the drug compared with the normal population, said Michael Parks, a spokesman for Centocor, the J&J unit that markets Remicade.
J&J said it would send a letter to doctors on Monday informing them of the danger.
It will be the second time in three months that Remicade's label has been changed to reflect safety concerns that are already listed in the prescribing information for the rival drugs.
In August, J&J changed its label to add the risk of certain blood-related disorders such as leukopenia, in which the white blood cell count is too low, and thrombocytopenia, when blood platelets are too low.
"This just spotlights the fact that there is no long-term safety data on this class of drugs and it's not clear what else is going to come out of the closet," said Henry Dummett, an analyst at World Markets Research Center. "That represents a downside risk to their long-term sales potential."
Enbrel, Remicade and Humira are members of a class of drugs that block an inflammation-causing protein called tumor necrosis factor. They have been among the most successful of all biotechnology drugs.
Other safety concerns have arisen recently about this class of drug. In August, U.S. health officials said 12 Californians who had taken Remicade or Enbrel had tested positive for tuberculosis. Two of those infected died.
A report from the Centers for Disease Control and Prevention (news - web sites) said that as the use of these blocking agents expands, associated cases of TB might increase.
In the case of lymphoma, J&J said the incidence of the blood cancer among rheumatoid arthritis patients taking Remicade is about three times the rate of the normal population.
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