A report from Biogen Idec has confirmed two further cases of
progressive multifocal leukoencephalopathy (PML)
in people with multiple sclerosis (MS) in the EU.
The first person had
an aggressive form of MS and had been taking
Tysabri for approximately 17 months. They are now in a stable
condition at home. The second person had taken Tysabri for around 14 months and
is currently in hospital. Possible signs and symptoms of PML were identified
through the risk management program which monitors for signs of the condition.
As of the end of June 2008 more than 31,800 people worldwide are being
treated with Tysabri. The two new cases of PML were confirmed at the end of July
2008, bringing the total of people who have developed PML to five.
Lee
Dunster, Head of Research at the MS Society, said: 'We know the reports of two
new cases of PML will be of some concern to people who are taking the drug,
however we would reassure people that the risk of developing these serious side
effects remains very small. As with all treatments, the benefits must be weighed
with the risks of side effects and these issues should be discussed fully
between you and your doctor.'
More information about Tysabri and PML MS Society
