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Last Updated: Apr 22, 2008 - 11:43:10 AM |
TUESDAY April 22, 2008 (foodconsumer.org) -- The Food and Drug Administration today announced its approval of Cimzia or (certolizumab pegol) for treatment of patients with Crohn's disease. The drug is manufactured by UCB, Inc., Smyrna, GA.
Cimzia provided with a Medication Guide is indicated for adults with moderate to severe Crohn's disease who have not responded to conventional therapies. On Jan 14, 2008, the FDA also approved another drug known as Tysabri to treat moderate to severe Crohn's disease.
Crohn's disease, an incurable chronic, inflammatory bowel disease, affects more than 1 million men and women worldwide, according to the FDA.
The disease 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."
One injection of Cimzia is given to patients every two weeks for the first three injections. Afterwards, the drug can be given once in every four weeks.
Cimzia is not free of side effects. The most common side effects of Cimzia, according to the FDA, include headache, upper respiratory infections, abdominal pain, injection site reactions and nausea.
Also, patients taking Cimzia are at increased risk of serious adverse effects, including serious infections that can lead to hospitalization or death. This is because the drug affects the immune system and it can lower the body's ability to fight infections, such as tuberculosis and other opportunistic infections.
In addition, Cimzia as a blocker of TNF (tumor necrosis factor) may cause lymphomas (a form of cancer) and other malignancies. Incidence of these adverse effects has not been seen in trials due to the modest size and relatively short duration of the controlled studies prevents any firm conclusion. But post-marketing studies and clinical trials will be required to obtain long-term safety data.
Patients taking Cimzia are advised to pay attention to infections. They should be educated about how to identifying infections and be instructed to contact their health care professional at the first sign of infection while on Cimzia. In cases of serious infections, they should stop using the drug immediately.
For more information on Crohn's disease, visit:
Crohn's Disease–National Institute of Diabetes and Digestive and Kidney Diseases
© 2004-2008 by foodconsumer.org unless otherwise specified
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