EMEA Concludes New Advice To Doctors And Patients For Tysabri (natalizumab) Needed, Europe
March 25, 2008
The European Medicines Agency (EMEA) has concluded that warnings aboutliver injury should be added to the product information for Tysabri(natalizumab).
Tysabri is used to treat relapsing-remitting multiple sclerosis (MS) inpatients with high disease activity despite treatment with abeta-interferon or whose disease is severe and evolving rapidly.
Following a review of reports of liver injury in patients treated withTysabri, the EMEA’s Committee for Medicinal Products for Human Use(CHMP) concluded that there is a need to update the product informationfor Tysabri to warn patients and prescribers that liver injury mayoccur.
Doctors should monitor the liver function of patients receiving Tysabri.Patients who observe any signs of liver injury, such as yellowing of theskin or the whites of the eyes, or unusual darkening of the urine shouldsee their doctor.
The CHMP has requested that Elan, the marketing authorisation holder forTysabri, submits a variation to the marketing authorisation to implementthese changes.
As with all medicinal products, the EMEA will continue to monitorTysabri closely to ensure that the benefits of the medicine continue tooutweigh its risks.
Notes:
1. More information about the EMEA recommendation is available in aquestion-and-answer document here.
2. More information about Tysabri, including the currently approvedinformation to prescribers and patients can be found in the EuropeanPublic Assessment Report
European Medicines Agency
