其 他 安 全 警 示
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| The United States: Tysabri (natalizumab) - Update of Healthcare Professional Information(English Only) |
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FDA has updated the Tysabri (natalizumab) Prescribing Information to give new information about the size of the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri for the treatment of multiple sclerosis (MS) and Crohn's disease. The update includes new safety information about patients who have taken other drugs that suppress the immune system, who may be at a higher risk for PML. The revised label includes a table summarizing rates of PML with Tysabri use according to the number of infusions (how long the drug is taken or duration of exposure) and information on a newly identified PML risk factor.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199965.htm
In Hong Kong, the above product is not registered. News related to Tysabri had been posted on the website of pharmaceutical service on 18 September 2009 and 19 May 2010 respectively.
Ends/ Tuesday, April 26 2011
Issued at HKT 12:30
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