Research shows the immunosuppressant drug certolizumab pegol—sold under the brand name Cimzia—increases the risk of infection by the bacteria Legionella and Listeria.
What Is Cimzia? When Is It Prescribed?
Cimzia is the brand name for the drug certolizumab pegol. Made and sold by Union chimique belge (UCB), a Belgian pharmaceutical company, this prescription medication is used to treat several autoimmune conditions. The U.S. Food and Drug Administration (FDA) first approved the drug in April 1998. Doctors prescribe it for Crohn’s disease and, with methotrexate, rheumatoid arthritis. It comes in 200 mg intravenous injections.
A member of the Tumor Necrosis Factor-alpha blocker (TNF-alpha blocker) class of immunosuppressant drugs, Cimzia works by binding to TNF-alpha, a natural cell-signaling molecule that attaches to immune cells. TNF-alpha blockers prevent TNF-alpha from binding with cells because TNF-alpha can cause inflammation in tissues, which leads to autoimmune diseases. By inhibiting it, Cimzia prevents the autoimmune response.
Cimzia Might Leave Users Vulnerable to Legionnaires’ Disease and Listeriosis
In September 2011, the FDA issued a Cimzia warning in the form of a Drug Safety Communication stating that Cimzia, along with other TNF-alpha blockers, increases the risk of infection by the bacteria Legionella and Listeria. The agency updated the drug’s label information to include a “black box” warning to reflect these developments. Black box warnings are the FDA’s most serious alert. Because TNF-alpha blockers reduce the immune system’s ability to fight infections, the body is vulnerable to potentially fatal infections by opportunistic organisms that attack multiple organ systems at once. Examples include:
- mycobacterial (tuberculosis)
- fungal (histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, blastomycosis, pneumocystosis)
- viral (hepatitis B)
The FDA has also warned that the drug leaves the body vulnerable to two other bacteria strains.
Legionella bacteria are named for their eponymous outbreak at a convention of the American Legion in a hotel in 1976. Members at the convention came down with a fatal pneumonia, which physicians named “Legionnaires’ disease.” They traced the source of the outbreak to bacteria in the hotel’s damp air conditioning system. These are the symptoms of Legionnaires’ disease:
- dry cough
- muscle aches
- loss of appetite
- loss of coordination
- impaired cognition
- low heart rate despite fever
- renal, liver, and electrolyte disorder
Legionella infection can also cause a weaker disease called “Pontiac fever.”
According to the FDA’s Adverse Event Reporting System, between 1999 and 2010, 80 patients developed Legionella infections after using a TNF-alpha blocker. Most were using the drug for rheumatoid arthritis. Many of the 80 patients were also taking methotrexate, corticosteroids, or both, with Cimzia. Fourteen of the 80 patients died.
The Listeria genus of bacteria is named after British scientist and developer of antiseptics Joseph Lister. Listeria infections, called “listeriosis,” last seven to ten days and have the following symptoms:
- muscle aches
- diarrhea (less common)
- meningitis (if the infection spreads to the nervous system)
The disease mostly affects newborns, the elderly, and pregnant women. The listeria bacteria mainly enter through contaminated food products, particularly those of the tainted dairy variety.
The FDA identified 26 cases in English-language medical publications of TNF-alpha blocker users coming down with listerioris. These infections resulted in meningitis, bacteremia, endophthalmitis, and sepsis. As with the Legionella-infected patients, many Listeria-infected patients were also using other immunosuppressive drugs. Seven patients died of their infections.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Cimzia lawsuit on your behalf if necessary.
If you have taken Cimzia and believe it harmed you, contact RLG today.