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)