FDA Announces Black Box Label Warning for Cimzia
FDA approved TNF inhibitors in 1998. Cimzia was one of them. These TNF blockers were called miracle drug as they reduced inflammation in rheumatoid arthritis and Crohn’s disease. Later they were linked with life threatening side effects. They are linked with increased risk of developing cancer in children and adults.
Cimzia is the brand name for certolizumab. It reduces inflammation in the body. It is used for treatment of the symptoms of Crohn’s disease. It is also used for treatment of moderate-to-severe rheumatoid arthritis in adults. It is also used for other purposes.
Cimzia is a TNF blocker. It is used to treat inflammation in Crohn’s disease. In Crohn’s disease the digestive tract becomes inflamed and adversely affects the gastrointestinal tract. It is also used to reduce or prevent inflammation in rheumatoid arthritis. It blocks TNF and reduces or prevents destruction of joints. It is being investigated for the potential risk of cancer as well as the risk of developing life-threatening infections.
In early September, 2008, FDA decided to add black box warning to the label of Cimzia. It was a result of reports pouring in about Cimzia being associated with increased risk of developing cancer and other life threatening infections. This led to an investigation of TNF blockers by FDA. FDA studies related Cimzia with potential risk of developing cancer as well as other life threatening infections.
In September 2008 FDA announced stronger warnings for four medications used in the treatment of rheumatoid arthritis. It decided to add black box warning, which is regarded as stringent warning. It is given on the label of those drugs that carry a high risk of serious side effects or potentially deadly adverse reactions. It is the strongest warning the FDA can issue for a prescription drug. Cimzia and such other TNF inhibitors belong to immunosuppressants category of drugs. These drugs essentially suppress the immune system’s reaction to illnesses, decreasing the body’s ability to fight off disease and infections. These drugs can cause serious complications, if used regularly. They also make patients more prone to any type of infections.
The FDA’s announcement concluded that this medicine can provide relief from the symptoms of rheumatoid arthritis, Crohn’s disease, and juvenile arthritis but the risk of developing infections due to weak immune system was potentially fatal and could cause deadly effects in several cases.
The FDA tried to provide information about other potential risks of this medicine. A distinct fungal infection known as histoplasmosis was reported in numerous patients taking this drug. Many of patients suffering from this disease even died. This is a respiratory infection with symptoms similar to the flu. It can spread to other organs of the body, if not treated. Once it spreads in the body results could be fatal. FDA investigation showed that half of the patients, who were diagnosed late for this infection, died. The FDA asked patients to immediately consult a doctor if any of the side effects of taking Cimzia such as persistent fever, cough, and shortness of breathe or fatigue occur. It also asked medical community to consider the possibility of anti fungal drug use in patients.
The FDA also cautioned patients and doctors about a rare malignancy, hepatosplenic T-cell lymphoma, which could be developed by use of Cimzia and other such drugs. Most cases of this disease occur in patients with Crohn’s disease or ulcerative colitis. It asked patients and doctors to be aware of signs and symptoms of lymphoma, including hepatosplenomegaly, weight loss, abdominal pain, fever, and night sweats. It asked drug users to immediately seek medical help in case of any side effects or unusual feeling.