Warning has been added to the Prescribing Information of Tysabri (Natalizumab)

    February 29, 2008 – The U.S Food and Drug Administration (FDA), the equivalents of the Saudi Food and Drug Authority (SFDA), announced that the Biogen ldec and Elan the manufacturer of TYSABRI" (natalizumab),a medicine used to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the number of relapses, has notified healthcare professionals that the full Prescribing Information has been revised to add to the Warnings and Precautions section information related to clinically significant liver injury that has been reported in patients treated with TYSABRI in the post-marketing setting, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients.

General Recommendations:

Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.

Report Adverse Drug Reactions to the Saudi FDA

The public and health professionals are encouraged to report adverse drug reactions of TYSABRI to the National Pharmacovigilance center on the internet at: