Friday, April 25, 2008
Cimzia Approved to Treat Crohn's Disease - Another New Crohn's Drug
The US Food and Drug Administration has approved a new drug for sufferers of Crohn's disease. Certolizumab pegol (Cimzia) received approval for use in 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 is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, MD, Director, Office of Drug Evaluation III, Center for Drug Evaluation and Research, FDA, Rockville, Maryland. "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 healthcare professionals."Patients treated with certolizumab will receive an injection every 2 weeks for the first 3 injections. Once benefit has been established, certolizumab should be given once every 4 weeks.The most common side effects of certolizumab are headache, upper respiratory infections, abdominal pain, injection-site reactions, and nausea.Patients taking certolizumab are at increased risk for serious adverse effects, including serious infections that can lead to hospitalisation or death. Because certolizumab affects the immune system, it can lower the body's ability to fight infections, such as tuberculosis and other opportunistic infections. Certolizumab is a tumour necrosis factor inhibitor and may cause lymphomas and other malignancies. Although an increased risk of tumours was not noted in studies of certolizumab, the modest size and relatively short duration of the controlled studies prevent any firm conclusion. Postmarketing studies and clinical trials will be required to obtain long-term safety data.Patients taking certolizumab should be educated about how to identify an infection and should be instructed to contact their healthcare professional at the first sign of infection. In cases of serious infections, the drug should be discontinued immediately.SOURCE: US Food and Drug Administration
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3 comments:
I love how they aren't afraid to push a drug through to the public. When the treatment cause more concern then the disease it makes me concerned. I look at the people who control their Crohn's though diet. Crohn's Disease can be controlled with diet and other herbal ways.
My friend sent me your blog. I recently found out I'd been misdiagnosed--I had been living with UC for 4 years never finding anything that worked and opted for the surgery (I WANTED MY LIFE BACK!!)--having my entire colon removed, j-pouch built, etc. That was 9 1/2 months ago and my life has just fallen apart. I had a case of horrible diarhea in Oct. and in November developed a fistula. It abcessed in December and in January they tried to repair it. That surgery failed 3 times before they finally gave me an illiostomy. I am now being told that my small intestine (all I have left!) is ulcerated and I have had Crohn's. The surgery I had is NOT for someone with Crohn's. They are going to put me on Humira. I just hope that this will help me get back on my feet since I have been down for 9+ months and I have a 2 and 6 year old that need their Mommy back! There is a lifetime of regret in my heart right now and I just have to give that up to God and go on somehow. Thank you for your blog. I pray for a remission in your future soon!
J. Berglan
whoever left the post about crohn's being controlled by diet and herbal ways OBVIOUSLY does not live with a severe form of Crohn's. I have fought for my life for the past twelve years, having blood transfusions, iv iron and vitamins, numerous hospital stays, and uncountable "herbal" and "natural" remedies. The first thing to EVER help me was Humira and you could not make me give it up for some black box warning. I will do whatever is necessary to have SOME sort of a functioning life. You would be crazy to think anyone would intentially withhold something from themselves. People like you are the ones that get these lifesavers taken off the market. There is nothing worse than to have something give you your life back and then "they" say too many people react. Leave well enough alone, some of us care more about the QUALITY of our lives. Anyone could die in a car accident or freak accident and I should be scared of a possible side effect? Get real, i would rather be there for my family NOW.
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