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MHRA issues MS treatment risk update

Risk of progressive multifocal leukoencephalopathy (PML) is increased in patients receiving natalizumab (Tysabri) who have had previous immunosuppressant treatment

By Tim Locke
WebMD Health News

Medically Reviewed by Dr Rob Hicks

4th March 2011 - The UK medicines regulator MHRA has issued a new warning over the MS treatment natalizumab (Tysabri).

There is already a risk of progressive multifocal leukoencephalopathy (PML) with the treatment, which was known when it was given a licence. PML is a potentially deadly - but rare - progressive, and demyelinating brain disease.

Now the MHRA is alerting doctors to the extra risk in patients who have received immunosuppressant treatments - such as azathioprine, cyclophosphamide, mitoxantrone and methotrexate - before receiving natalizumab.

The MHRA says patients need to be told of the extra risk.

The risk of PML also increases with the duration of treatment, especially beyond two years.

The Multiple Sclerosis Resource Centre (MSRC) says there have been 95 PML cases worldwide with Tysabri and 20 deaths.

Natalizumab (Tysabri) is given by IV drip monthly. It is recommended for severe, rapidly evolving relapsing-remitting MS. It costs the NHS £1,130 per infusion.

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