USA. Genentech has issued a new warning regarding events of immune-mediated haemoltyic anaemia associated with efalizumab-use, indicated in the treatment of severe plaque psoriasis in adult patients (18 years or older). According to Genentech, two cases of haemolytic anaemia were observed in efalizumab (Raptiva) clinical trials; two additional cases were reported in the postmarketing setting. In its letter to health-care providers Genentech has stated that a causal relationship between efalizumab (Raptiva) and these events has not been established but cannot be excluded and that health-care providers should discontinue treatment if haemolytic anaemia occurs.
'Dear Health-care Provider' letter from Genentech, Inc., July 2005 (http://www.fda.gov).