Safety Alerts & Recalls

What does this mean?

Since natalizumab (also known by the brand name Tysabri) is used to treat the serious condition of multiple sclerosis, its benefits will continue to outweigh its risks in the majority of cases. If you are receiving treatment with natalizumab you should not stop taking your medication unless advised to do so by your doctor. If you have any concerns regarding this alert or your treatment with natalizumab, please discuss this further with your doctor or other healthcare professional.

Safety Information Updated About The Risk Of Progressive Multifocal Leukoencephalopathy With Natalizumab

Biogen Idec has issued updated safety information to healthcare professionals regarding the risk of developing progressive multifocal leukoencephalopathy (PML) in patients taking natalizumab (Tysabri). The information warns that patients are at increased risk of PML if they have been treated in the past with a drug that suppresses their immune system, which is independent in the treatment duration of natalizumab. Doctors are advised to perform a magnetic resonance image (MRI) scan, start treatment with Tysabri within three months, and to repeat the scan on a yearly basis. They should reassess the risks and benefits of the treatment after two years, and discontinue treatment promptly if PML is suspected.

Natalizumab (Tysabri) reduces the movement of white blood cells into the central nervous system to reduce the inflammation and damage to nerve sheaths that occurs in multiple sclerosis. PML is caused by the reactivation of a common virus in the central nervous system of people whose immune system is not working effectively – this damages the protective nerve sheaths in the brain and means that signals cannot travel normally from the brain to the body, which can be fatal.

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Source: MHRA
Publication Date: 2011-03-08
Last Updated: 2011-03-08

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