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The European Agency for the Evaluation of Medicinal Products (EMEA)
reported recently that twenty-eight people in North America and
Europe have developed tuberculosis soon after they were
given the anti-inflammatory drug Remicade
(infliximab).
The EMEA said that in view of the seriousness of these reports,
it was recommending that Remicade treatment should be stopped
if active TB is suspected in any patient until the diagnosis was
ruled out or the infection had been treated.
Remicade is used to treat rheumatoid
arthritis and Crohn's disease, which is characterized
by diarrhea, cramping, and loss of appetite. Around 100,000 people
worldwide have taken it since it was launched in the US in August
1998 and since it received European marketing authorization in August
1999.
The drug is marketed by Schering-Plough in Europe and by Johnson
& Johnson in the United States.
"To date, 28 cases of TB have been reported (nine cases
in North America and 19 cases in Europe) of which one had a fatal
outcome," the EMEA said in a December 20 statement.
"In a significant proportion, the onset of active TB occurred
after three or less infusions of Remicade, thus supporting a possible
relationship with initiation of Remicade therapy,'' the agency
added.
European Agency for the Evaluation
of Medicinal Products (EMEA)
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