EMEA warns of liver injury with Tysabri

The European Medicines Agency (EMEA) has concluded that warnings about liver injury should be added to the product information for Tysabri (natalizumab). The product, which is made by US drugmaker Biogen Idec and Ireland's Elan, is used for relapsing-remitting multiple sclerosis in patients with high disease activity despite treatment with a beta-interferon or whose disease is severe and evolving rapidly.

Following a review of reports of liver injury in patients treated with Tysabri, the EMEA's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to update the product information to warn patients and prescribers that liver injury may occur. Doctors should monitor the liver function of patients receiving Tysabri, the agency noted. Patients who observe any signs of liver injury, such as yellowing of the skin or the whites of the eyes, or unusual darkening of the urine should see their doctor. The CHMP has requested that Elan, the marketing authorization holder for Tysabri, submits a variation to implement these changes. As with all medicinal products, the EMEA says it will continue to monitor Tysabri closely to ensure that the benefits of the medicine continue to outweigh its risks.