Warning Added To Remicade Label
Remicade (infliximab), a popular rheumatoid arthritis 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 is also used as a treatment for Crohn's disease, as well as rheumatoid arthritis. Since Remicade was first approved in the United States on August 24, 1998 approximately 509,000 patients have been treated with Remicade across the world. According to Reuters News, 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. In the letter, Centocor encouraged the reporting of adverse events by healthcare professionals and consumers so that the safety of Remicade can be monitored.
Other TNF Blocker Drugs Carry Similar Warnings
It should be noted that Enbrel (etanercept from Amgen, Inc.) and Humira (adalimumab from Abbott Laboratories, Inc.) carry similar warnings on their labels regarding blood disorders.
Remicade, Enbrel, and Humira are anti-TNF drugs and work by blocking tumor necrosis factor (TNF), a protein involved in causing inflammation.
Many patients on an anti-TNF drug are able to successfully control the pain and inflammation associated with rheumatoid arthritis. The additional warning does not diminish the great benefit of anti-TNF drugs, rather it reminds patients and doctors to be vigilant and conscientious about reporting adverse events, if they occur.
