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Johnson & Johnson's labeling for its drug Remicade will be
updated with a boxed warning stressing that the drug can
increase the risk of infections.
The company's statement comes just 2 days before an advisory committee
to the US Food and Drug Administration (FDA) is scheduled to discuss
whether stronger warnings are needed for Remicade and Enbrel.
The drugs are tumor necrosis factor (TNF) blocking agents. In
excessive amounts, TNF is believed to trigger joint inflammation
-- but it also helps combat infections.
As a result, TNF inhibitors may increase the risk of infection,
especially in elderly patients taking immune-system-suppressing
treatments for other conditions. Remicade has been associated with
84 cases of tuberculosis worldwide,
including 14 fatal cases.
Along with strengthening the basic warning, the new label -- which
was devised in cooperation with the FDA -- will instruct physicians
to screen patients for tuberculosis and
treat any such infections before Remicade is prescribed.
The labeling revision also highlights the risk of various other
opportunistic infections, such as the serious lung infection pneumocystis.
Centocor plans to send letters to healthcare professionals and
create a patient leaflet to help reinforce the new information.
The company said it would also continue
to collect safety data on about 15,000 patients to ensure
that the labeling changes are sufficient.
Remicade has been prescribed to more than 170,000 patients since
its launch.
Immunex spokesperson Robin Shapiro said the company does not expect
its rheumatoid arthritis drug Enbrel to need a similarly strengthened
warning.
Last year, Enbrel's labeling was updated to include warnings about
the possibility of central nervous system disorders and pancytopenia,
a drop in the body's number of red and white blood cells.
Reuters August 15, 2001
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