Generic: Certolizumab Pegol
Date approved: 2008
Status: Prescription Only – FDA Black Box Warning Label
Approved uses: Crohn’s disease
Off-Label uses: None
• upper respiratory infections
• abdominal pain
• injection site reactions and nausea. Serious Fungal Infection possibly resulting in death.
Cimzia (Certolizumab Pegol)
Cimzia (certolizumab pegol) is an immunosuppresant, approved by the FDA for the treatment of Crohn’s disease, rheumatoid arthritis, and juvenile arthritis. It is administered through a subcutaneous injection.
The most common side effects of Cimzia are headache, upper respiratory infections, abdominal pain, injection site reactions and nausea. Patients taking Cimzia are at increased risk for serious adverse effects, including serious infections that can lead to hospitalization or death. Because Cimzia affects the immune system, it can lower the body’s ability to fight infections, such as tuberculosis and other opportunistic infections. Cimzia is a blocker of TNF (tumor necrosis factor) and may cause lymphomas (a form of cancer) and other malignancies.
Recently, Cimzia was given a Black Box Label Warning by the FDA. The Black Box Warning is the strongest warning label a drug can have applied to it. Drugs that carry a high risk of serious side effects or potentially deadly adverse reactions are given this warning. This label is given only after medical studies have indicated that there are serious risks associated with the side effects of the medication.
Cimzia Linked to Life-Threatening Cancer Risk Among Children, Young Adults
Cimzia (certolizumab pegol) is an autoimmune disorder drug belonging to a family of drugs known as tumor necrosis factor (TNF) inhibitors. Recently, Cimzia, along with several other TNF blockers, were linked to an increased risk of cancer among patients taking the drug, specifically among young adults and children.
The U.S. Food and Drug Administration (FDA) launched an investigation into the TNF blockers after at least 30 cases of cancer among children consuming the drugs were reported during a ten-year period from 1998 to 2008, according to a September 2008 news article from Reuters.
TNF Blockers Under Investigation
TNF inhibitors were first approved by the FDA in 1998. A book known as “Arthritis Without Pain” that was published in 2000 and revised in 2004, describes TNF inhibitors as a “miracle” drug, and that no known negative side effects or symptoms existed, however, this “miracle” theory was recently challenged by the FDA’s findings that the Cimzia may cause cancer. Of the TNF blockers under investigation are those that are used to treat autoimmune disorders and include:
• Remicade (infliximab)
• Humira (adalimumab)
• Enbrel (etanercept)
• Cimzia (certolizumab pegol)
According to the Mayo Clinic, TNF blockers are most often associated with the treatment of rheumatoid arthritis, in which the “wear and tear on joints” causes inflammation within the bones and joints. Nearly 2 million individuals in America suffer from the arthritic condition and it is most commonly found in women rather than in men. Additional TNF blocker side effects include:
What is Cimzia?
Cimzia is used specifically to treat Crohn’s disease a condition in which the digestive tract becomes inflamed and adversely affects the gastrointestinal (GI) tract, according to the National Digestive Diseases Information Clearinghouse (NDDIC).
Additional Cimzia Side Effects
In addition to the serious risk associated with developing cancer while consuming Cimzia, the drug also contains other various side effects that may cause severe damage to an individual’s health, according to an article in the Atlanta Journal-Constitution (AJC). Cimzia side effects include:
• abdominal paint
• upper respiratory infection
• reactions to the injection area
Cimzia was approved in April 2008 for use on the market by the FDA and while results from a clinical trial published in The New England Journal of Medicine, the drug is already being investigated for the potential risk of cancer as well as the risk of developing life-threatening infections.
Pharmaceutical Legal Assistance
Patients who have taken Cimzia or any of the additional TNF blockers and those who may be at risk for the potential Cimzia-induced cancer risk should seek medical attention immediately. Any type of cancer that can be caught early will likely result in a better outcome than one that is not detected until it has advanced to untreatable stages.
While the FDA has found an alleged link between TNF inhibitors including Cimzia and an increase in developing cancerous cells, they have not recalled any of the drugs nor have they increased the warning label of Cimzia, although all of the TNF blockers allegedly carry a cancer warning label. As part of the investigation, the FDA has asked that all cases of children and young adult cancer reports are given to the FDA immediately upon diagnosis.
Manufacturers of Cimzia, UCB, are currently preparing for a 10-year study to better understand the Cimzia side effects. The study will begin in 2009. However, patients who have taken the drug and currently are at risk for or suffering from the Cimzia dangers are advised to contact a pharmaceutical attorney regarding the development of a Cimzia class action lawsuit. Developing a Cimzia case may allow for monetary compensation for damages that were attributed to the consumption of the drug.
Living With Crohn’s Disease
Crohn’s disease is a physical disorder in which the inflammation of the digestive system occurs. The Crohn’s and Colitis Foundation of America (CCFA) has researched the potential causes of Crohn’s disease and have found that while more research is necessary as to the specific reasons behind the condition, the following are factors that may contribute to an individual developing the condition: genes (a family’s history of illnesses) an individuals immune system foreign substances such as antigens in the environment According to the CCFA, many scientists believe that “the interaction of an outside agent (such as a virus or bacterium) with the body’s immune system may trigger the disease.” Unfortunately, if an individual has a weakened immune system and they also have a family history of Crohn�s disease or ulcerative coliti , they are at a high risk for developing the disease. Both males and females are equally affected and individuals between the ages of 15 and 35 make up most of the population of Crohn’s disease sufferers , between 500,000 and 1 million Americans.