Other safety alerts
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| The United States: Drug Safety Communication - Tysabri (natalizumab): New risk factor for progressive multifocal leukoencephalopathy (PML) |
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FDA notified healthcare professionals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn's disease.
A patient's anti-JCV antibody status may be determined using an anti-JCV antibody detection test that has been analytically and clinically validated, and has been ordered by a healthcare professional. The Stratify JCV Antibody ELISA test2 was cleared by FDA on January 20, 2012. Testing positive for anti-JCV antibodies means that a person has been exposed to JCV in the past.
Tysabri (natalizumab) is in a class of medications called immunomodulators. It works by stopping certain cells of the immune system from causing damage to the body. Tysabri is approved for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn's disease since January 2008.
The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML. Patients with all three known risk factors have an estimated risk of PML of 11/1,000 users.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm288602.htm
In Hong Kong, the above product is not a registered pharmaceutical product. News related to Tysabri had been posted on the website of Drug Office on 18 September 2009, 19 May 2010 and 26 April 2011.
Ends/ Saturday, January 21, 2012
Issued at HKT 16:00
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