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J&J Warns of Blood Cancer Risk in Arthritis Drug
J&J Warns of Blood Cancer Risk in Arthritis Drug -- Posted by Roman Bystrianyk on 10-08-04 10:00
http://www.healthsentinel.com/news.php?event=news_print_list_item&id=313
"J&J Warns of Blood Cancer Risk in Arthritis Drug", Reuters, October
8, 2004,
Link: http://www.reuters.com/newsArticle.jhtml?type=domesticNews&storyID=6453375
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 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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