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Johnson & Johnson will warn users of its rheumatoid arthritis drug Remicade® that they have a higher risk of developing a blood cancer known as lymphoma.
The drug maker will also send out letters early next week informing doctors of the danger.
Remicade is a member of a class of drugs that block an inflammation-causing protein called tumor necrosis factor.
The warning, to be included in the drug’s package insert label, will warn users that they have three times the risk of developing lymphoma than for rheumatoid arthritis patients compared with the normal population.
The drug’s safety profile will now be similar to those of rival rheumatoid arthritis drugs Enbrel® and Humira® that are in the same class as Remicade.
Remicade’s label was changed in August to warn users that they could develop blood disorders involving low white blood cells and low blood platelet counts.
Source:
Medical Week Staff, week
of October 9, 2004
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