|
Remicade
Remicade (Infliximab) is an immune-suppressing drug used
to treat rheumatoid arthritis and Crohn's disease.
On October 5, 2001, Centocor, Inc., the manufacturer
of Remicade, issued a drug warning that states, “Tuberculosis,
and other serious opportunistic infectionsincluding
histoplasmosis, listeriosis, and pneumocystosis, have
been reported in both the clinical research and post-marking
surveillance settings. Some of these infections have
been fatal.” Because of these fatalities, the FDA
required the makers of Remicade to add a Boxed Warning
on the labeling of the product informing patients of
the increased risk of developing tuberculosis and other
opportunistic infections due to taking Remicade.
According to Centocor, Inc.’s letter to healthcare professionals,
as of October 2001, 170,000 patients worldwide had taken Remicade
to treat Crohn’s Disease and rheumatoid arthritis. 84
cases of tuberculosis had been diagnosed. Of those, 14 cases
were fatal.
Remicade and Tuberculosis
|
