Canada. Hoffmann-La Roche Limited has issued a notice to hospitals regarding important new safety information for daclizumab (Zenapax). A cardiac transplant study, conducted to determine if daclizumab reduced the incidence of acute rejection, found an increased 6- and 12-month mortality rate in patients who received daclizumab, compared with those who received placebo, in combination with cyclosporin, mycophenolate mofetil and corticosteroids. In some cases, investigators prescribed concomitant polyclonal antilymphocyte globulin therapy to protect patients who may be receiving placebo. However, due to the blinded nature of the study, some patients received both daclizumab and polyclonal antilymphocyte globulin therapy, and this over immuno-suppression may explain most of the elevated mortality, as well as the increased incidence of infection seen in patients who received daclizumab. The letter also contains information on severe acute hypersensitivity reactions, including anaphylaxis, which have been observed with daclizumab (Zenapax), both on initial exposure and on re-exposure. The Canadian Product Monograph will be revised to include statements related to both the increased mortality in the cardiac transplant study and to updated information regarding hypersensitivity reactions. A similar letter was also sent out by the company to health professionals in the USA, under advice from the FDA (see WHO Pharmaceuticals Newsletter No.5, 2003).
Notice to Hospitals from Hoffman-La Roche Limited, 11 November 2003. Available from URL: http://www.hc-sc.gc.ca