Wednesday, 13 February 2008

Chrons Disease Drug Tysabri has been approved

There is some great news for people who suffer from Chrons Disease in the US as the Food and Drug Administration has approved the use of a drug called Tysabri (natalizumab).

Tysabri which is produced by Ireland based company Elan and Biogen Idec in the USA is to be used on chrons patients who have not responded to other forms of treatment, it was given the green light in 2006 to treat people who have elapsing multiple sclerosis and will now be given the all clear to be used with people suffering from Chrons Disese.

Possible side effects of the drug include the risk of progressive multifocal leukoencephalopathy which is a viral infection that affects the brain. This viral infection could cause severe disability or even death. Another possible side effect are anaphylactic reactions and possible liver injury.

Because of these possible serious side effects people with chrons disease who are prescribed the drug Tysabri will also be added to a restricted distribution program called Crohn's Disease-Tysabri Outreach Unified Commitment to Health (CD-TOUCH).

This program will allow doctors to check the chrons disease patients that are using Tysabri after three months and will be asked to stop using the drug if there if there are no signs of improvement in that time.

Drug Details
Drug Name: TYSABRI (Brand Name Drug)
FDA Application No. (BLA) 125104
Active Ingredient: NATALIZUMAB
Original Approval or Tentative Approval Date: November 23, 2004
There are no Therapeutic Equivalents

Chrons Disease is an incurable disease that affects the bowel. Symptoms often include diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestines, cramping, and abdominal pain. Chrons disease affects more than one million people around the world and can also lead to abnormal connections that are called fistulas from the intestines to the skin or internal organs.

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