Remicade (infliximab), a popular drug, had important safety information added to its label by Centocor (the maker of Remicade) and the U.S. Food and Drug Administration. Based on worldwide postmarketing experience the following hematologic events, sometimes fatal, were reported in patients receiving Remicade:
- Leukopenia (low white blood cell count)
- Neutropenia (low number of neutrophils, a type of white blood cell)
- Thrombocytopenia (low blood platelet count)
- Pancytopenia (a shortage of all types of blood cells, including red and white blood cells and platelets)
How The Warning Reads
The additional warning reads:
Hematologic Events
Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with a fatal outcome, have been reported in patients receiving REMICADE. The causal relationship to REMICADE therapy remains unclear. Although no high-risk group(s) has been identified, caution should be exercised in patients being treated with REMICADE who have ongoing or a history of significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever) while on REMICADE. Discontinuation of REMICADE therapy should be considered in patients who develop significant hematologic abnormalities.
Updates On Other Warnings
Additionally, an update was made to the Warning on Neurologic Events to describe rare cases of central nervous system manifestation of systemic vasculitis (blood vessel inflammation in the brain and spinal cord). Discontinuation of Remicade is obviously recommended for patients who develop significant central nervous system adverse reactions. To the Adverse Reaction section of the Remicade Prescribing Information, neutropenia,
pericardial effusion, and systemic and cutaneous
vasculitis have been added.
Remicade : Since Remicade was first approved in the United States on August 24, 1998 - 508 cases of the aforementioned problems (hematologic and neurologic) have been reported worldwide.
Letter Sent To Healthcare Professionals
A letter was sent on August 11, 2004 to notify doctors of the changes to the warning label.
August 11, 2004 Letter To Healthcare Professionals, "Important Drug Warning" (*pdf file*)