Psoriasis drug withdrawn over brain disease fears

 

A drug used by about 60 psoriasis sufferers in the Republic has been withdrawn from the market over fears it may be linked to a rare brain infection.

The Irish Medicines Board (IMB) today suspended the marketing of Raptiva (efalizumab) after the European Medicines Agency (EMEA) warned that use of the drug no longer outweighed the risks.

Authorised throughout the European Union since September 2004, Raptiva is used to treat adults with moderate to severe chronic plaque psoriasis who have failed to respond to other more common treatments.

The European Commission has requested a review of the drug following reports of serious side effects in patients who had used the drug for more than three years.

These side effects included three cases of the potentially lethal brain disease PML (progressive multifocal leukoencephalopathy), two of which were fatal.

The IMB today advised doctors and pharmacists not to issue any prescriptions for Raptiva to patients who are not already taking it and to review patients currently taking this medicine with a view to stopping treatment. 

Dr Joan Gilvarry, director of human medicines with the Irish Medicines Board, said the decision was taken as a precautionary measure to protect patient health.