Cimzia, a TNF (tumor necrosis factor) alpha blocker drug used to suppress the immune system for patients with Crohn's disease and rheumatoid arthritis has been linked to potentially deadly fungal infections by the U.S. Food & Drug Administration (FDA) – which is now requiring manufacturers to alert patients and prescribers of those risks.
What is Cimzia & what are the side effects associated with it?
Cimzia (certolizumab pegol), manufactured by UCB Global Pharma is a TNF alpha blocker used to suppress the immune system and is prescribed for patients with Crohn's disease and rheumatoid arthritis. It was approved by the FDA in 2008 to treat Crohn's disease and approval for the treatment of rheumatoid arthritis was given in 2009. The manufacturer provides the following warning:
CIMZIA is a medicine that affects your immune system. CIMZIA can lower the ability of the immune system to fight infections. Serious infections have happened in patients taking CIMZIA, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections. (Source: www.cimzia.com)
However, the FDA has stated that the warning may not be strong enough. It points to a reported case of histoplasmosis in a patient taking Cimzia and says it has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF blockers. The FDA is requiring UCB to conduct further studies on the drug. However, Cimzia is not the only TNF alpha blocker being linked to severe injuries and deaths.
Humira, Enbrel & Remicade
The FDA has also reported that it has reviewed 240 reports of histoplasmosis, an infection caused by the fungusHistoplasma capsulatum, in patients being treated with Enbrel, Humira or Remicade. In fact, the FDA is now requiring manufacturers to submit safety labeling changes that must include strengthened warnings and revisions to medication guidelines.
If you've been injured due to one of these TNF-alpha blockers, contact a products liability attorney to discuss your situation and evaluate your options.
