NEWS - J&J: Arthritis Drug May Hike Cancer Risk

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J & J: Arthritis Drug May Hike Cancer Risk

Fri Oct 8, 5:14 PM ET

By Toni e

NEW YORK (Reuters) - & 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.

Remicade is not related to the arthritis drug Vioxx, which was pulled

off the market last week by Merck & Co. Inc. after a study showed it

doubled the risk of heart attack and stroke.

Remicade's label will be revised to warn of a three-fold increase in the

risk of lymphoma for rheumatoid arthritis patients taking the drug, said

Parks, a spokesman for Centocor, the J & J unit that markets

Remicade.

The change means the drug's safety profile will be more closely aligned

with that of rival drugs in the same class: Amgen Inc.'s Enbrel and

Abbott Laboratories Inc.'s Humira. All three drugs block an

inflammation-causing protein called tumor necrosis factor, or TNF.

The TNF-blockers have been among the most successful of all

biotechnology drugs, with combined sales of $4.1 billion in 2003. Those

sales show no sign of slowing. But some analysts say the revised label

for Remicade casts an additional shadow over a class that is already

attracting a small but growing amount of concern.

U.S. health officials in August said 12 Californians who had taken

Remicade or Enbrel had tested positive for tuberculosis. Two of those

infected died, and 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.

" 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. "

J & J said it would send a letter to doctors on Monday alerting them to

the revised label for Remicade. The company said it has discovered no

causal relationship between higher rates of lymphoma and Remicade

because rheumatoid arthritis patients are at a higher risk of lymphoma

anyway.

It will be the second time in three months that Remicade's label has

been changed. In August, J & J added 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.

Schaible, vice president of medical affairs at Centocor, said the

company has been working with the U.S. Food and Drug Administration

(news - web sites) since the agency last year indicated it would request

similar warning labels for Remicade, Enbrel and Humira. Abbott changed

its label early this year, and Amgen changed late last year.

Schaible said J & J submitted its change of label request to the FDA

(news - web sites) in March and received the agency's sign-off only

recently.

" I don't think its a coincidence that J & J is doing this now, right after

Vioxx and the troubles GlaxoKline has had, " said Webster,

president of Webster Consulting Group. " I think that pharmaceutical

companies are going to get very conservative about serious side effects,

especially in populations with non-life-threatening conditions. "

In June, New York Attorney General Eliot Spitzer accused GlaxoKline

Plc of suppressing important, negative information about the use of its

antidepressant Paxil in children.

However, Centocor's Parks said the move had nothing to do with Vioxx or

Glaxo and said the change had been in the works for months.

" Anyone who suggests otherwise is misinformed about the FDA process, " he

said.

Rheumatoid arthritis affects about 2.1 million people in the United

States. Remicade was approved in 1998 to treat Crohn's disease. It was

approved for rheumatoid arthritis in 1999.

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