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Details:
A new drug has been approved to help sufferers of Crohn's disease, the U.S.
Food and Drug Administration announced today. Cimzia (certolizumab pegol)
received approval for adults with moderate to severe Crohn's disease who have
not responded to conventional therapies. This product was approved with a
Medication Guide.
Crohn's disease is a chronic, inflammatory bowel disease that affects more than
1 million men and women worldwide. It has no cure and its cause is unknown.
Crohn's can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of
the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It
also can lead to abnormal connections (fistulas) leading from the intestine to
the skin or internal organs.
"Crohn's is a debilitating disease that disrupts the quality of life for its
sufferers," said Julie Beitz, M.D., director of the Office of Drug Evaluation
III for the FDA's Center for Drug Evaluation and Research. "This drug works to
reduce the signs and symptoms of Crohn's, but it also carries risks that will
require patients on it to be closely monitored by their physicians or other
health care professionals."
Patients treated with Cimzia will receive an injection every two weeks for the
first three injections. Once benefit has been established, Cimzia should be
given once every four weeks.
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. Although an increased risk of tumors was not
seen in studies of Cimzia, the modest size and relatively short duration of the
controlled studies prevents any firm conclusion. Post-marketing studies and
clinical trials will be required to obtain long-term safety data.
Patients taking Cimzia should be educated about how to identify an infection and
be instructed to contact their health care professional at the first sign of
infection while on Cimzia. In cases of serious infections, the drug should be
discontinued immediately.
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