European regulators recommend suspending sales of Raptiva (efalizumab) manufactured by Genenetech Inc. for the treatment of psoriasis after the drug was linked to three, and possibly four cases of a deadly brain infection.  The brain infection, known as progressive multifocal leukoencephalopathy or PML, has killed three patients taking Raptiva.  The U.S. FDA issued a public health advisory regarding the risks identified with using the drug, but has not sought removal from the market.  The health advisory provides the following advice for doctors and patients:

Healthcare providers should, in the interim, be aware of the following information and advice:

  • Raptiva increases the risk of PML.  Longer, continuous use may further increase this risk.
  • Inform patients using Raptiva of the potential risk of developing PML.
  • There are no known screening tests that can reliably predict PML or medical interventions that can prevent or treat this disease.  
  • Monitor patients being treated with Raptiva for the onset of neurologic symptoms.  Discontinue Raptiva if PML is suspected.
  • Patients treated with Raptiva should be periodically re-evaluated to ensure that the benefit of treatment continues to outweigh the risks.  Consideration should be given to use of other approved therapies to control the patients’ psoriasis.
  • The effects of periodic or intermittent use of Raptiva, or the concomitant use of other immunosuppressant drugs on the risk for PML is not known.

Patients using Raptiva should:

  • Be aware that Raptiva increases the risk of developing PML.  PML is a disease that is fatal or causes severe disability.
  • Talk with their healthcare provider about the benefits and risks of treatment with Raptiva.
  • Be aware of the symptoms of PML which may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and sometimes personality changes.
  • Contact their healthcare provider immediately if they experience these symptoms.  
  • Understand that there are no laboratory screening tests for PML or medical interventions that can prevent or treat PML

The recommendation to remove the drug from the market is based on the conclusion by European regulators that the drug’s costs to the patient outweigh the benefits.