Tysabri labelling changes recommended

22 January 2010

The European Medicines Agency has recommended new measures for dealing with the risks associated with the drug natalizumab (Tysabri).

The decision follows a three month review of the benefits and risks of the drug. The review identified 31 cases of PML (progressive multifocal leukoencephalopathy), a potentially deadly brain infection, since July 2008. Of these, 23 people had been taking Tysabri for more than two years. Despite the additional cases, the risk of PML remains roughly one case in a thousand, which is consistent with the risk noted in the drug's prescribing label. The review concluded that the benefits of Tysabri continue to outweigh risks for people with highly active relapsing-remitting multiple sclerosis.

The recommended label changes aim to ensure that people taking the drug are fully aware of the risks and also offer additional advice on how to manage people who show signs of PML. They include updating prescribing information about the increase in the risk of PML after two years and requiring people to sign a consent form when they start taking Tysabri and again after two years of treatment.

Pam Macfarlane, Chief Executive of the MS Trust said "We are pleased that this review has reported quickly. Whilst the risks of contracting PML remain generally low, these recommendations will ensure both health professionals and people considering or receiving treatment, are fully aware of the risks and remain vigilant."