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Efalizumab (Raptiva): Recommendation to suspend Marketing Authorisation as risks outweigh benefits

The European Medicines Agency has completed a review of efalizumab (Raptiva) after concerns about its safety. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of efalizumab do not outweigh its risks, and that the Marketing Authorisation should be suspended across the EU.

Efalizumab is used to treat adults with moderate to severe chronic plaque psoriasis (a disease that causes red, scaly patches on the skin) who have not responded to, or who are unable to take, other treatments for psoriasis (including ciclosporin, methotrexate, and PUVA).

This medicine was reviewed after reports of serious side effects, including three confirmed cases of progressive multifocal leukoencephalopathy (PML, a rare but serious disorder of the central nervous system) in patients who had received efalizumab for more than 3 years; two of these patients died.

Although psoriasis is a disabling condition that can cause social and psychological problems for patients, it is very rarely life-threatening. The Committee concluded that the risk of PML is unacceptable for patients taking efalizumab. They recommended that the Marketing Authorisation should be suspended until there is adequate new evidence to identify a group of patients in which the benefits of efalizumab outweigh its risks.

Advice for patients:

  • Patients who are currently taking efalizumab (Raptiva) should make an appointment with the doctor who prescribed it
  • Patients should not stop treatment with efalizumab abruptly because it could cause psoriasis to return or worsen. Your doctor will discuss with you the most appropriate replacement treatment
  • Patients who have taken efalizumab in the past and who have any questions or concerns should speak to their doctor or pharmacist.

Advice for healthcare professionals:

  • Prescribers should not issue any prescriptions for efalizumab to patients who are not already taking it
  • Prescribers should review the treatment of all patients who are currently taking efalizumab, with a view to stopping treatment
  • Treatment with efalizumab should not stop abruptly (which could cause psoriasis to return or worsen). Prescribers should consider alternative treatments and continue to monitor the patient’s psoriasis
  • Efalizumab’s effects on the immune system last for about 8–12 weeks. Healthcare professionals should closely monitor patients for infections and neurological symptoms after stopping treatment.

Further information is available on the European Medicine Agency’s website (external link).

Page last modified: 20 February 2009