July 2005 "Dear Doctor" Letter Warns About Some Blood Disorders, Also

Genentech Inc. and the FDA announced recently that the drug company had added a new warning for the psoriasis drug Raptiva about an increased risk of serious infections.  This package insert label change for Raptiva was introduced and explained by means of a July 15, 2005 Dear Healthcare Professional letter which was sent to prescribing doctors and others.  This so-called "Dear Doctor" letter from Genentech letter also informed prescribers that Raptiva users have a higher chance of developing decreased blood platelets as well as immune-mediated hemolytic anemia.

On July 20, 2005 MedWatch – the FDA’s safety information and adverse event reporting program – provided this email notification to doctors and others about the Raptiva label change:

Genentech and FDA revised the WARNINGS, ADVERSE REACTIONS sections and Patient Information Sheet for RAPTIVA (efalizumab), indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Healthcare professionals and patients were informed about reports of immune-mediated hemolytic anemia and warnings regarding postmarketing reports of thrombocytopenia and serious infections including necrotizing fasciitis, tuberculous pneumonia, bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia, and worsening of infection (e.g. cellulitis, pneumonia) despite antimicrobial treatment.

One can read the complete MedWatch Raptiva drug-safety alert, which includes links to the July 2005 Dear Doctor letter and the revised Raptiva warning label, to find out more.

(Posted by: Tom Lamb)