The European Medicines Agency (EMEA) has concluded that warnings about liver
injury should be added to the product information for Tysabri (natalizumab).
Tysabri is used to treat relapsing-remitting multiple sclerosis (MS) 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 for Tysabri to warn patients and prescribers that
liver injury may occur.
Doctors should monitor the liver function of
patients receiving Tysabri. 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 authorisation holder for Tysabri, submits a variation to the marketing
authorisation to implement these changes.
As with all medicinal products,
the EMEA will continue to monitor Tysabri closely to ensure that the benefits of
the medicine continue to outweigh its risks.
information about the EMEA recommendation is available in a question-and-answer
2. More information about Tysabri,
including the currently approved information to prescribers and patients can be
found in the European Public Assessment Report European Medicines