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Added March 28th, 2006
The Food and Drugs Administration has reported that there could be up to a three month delay with its decision relating to the multiple sclerosis drug Tysabri, and whether it will be allowed back onto the market. This follows concerns about the safety of the drug and its potential to cause harmful side effects in patients taking the medication.
It is reported by the manufacturers of the drug that it could take until the end of June for the FDA to reach a decision through the review of a risk management plan put forward. This is in a bid to prevent further harmful side effects following three incidents of a rare brain disease found in patients during clinical trials.
The drug had only been on the market for a matter of several months when it was pulled from the shelves last year after the disease, known as progressive multifocal leukoencephalopathy, came to light.
A spokesperson for the drug manufacturer stated: ''We're disappointed. At the advisory committee meeting, we heard patients speak very passionately about the unmet medical need in multiple sclerosis. We're continuing to work around the clock to make Tysabri available as quickly as possible."
Delay On MS Drug’s... | Printable Version (Opens In New Window)