The US Food and Drug Administration (FDA) has announced labeling changes that affect the popular psoriasis drug, efalizumab, marketed under the brand name, Raptiva. The updated label warning is the result of the increased risk of developing life-threatening infections when using this medication.

Only patients 18 and older who have moderate to severe plaque psoriasis are approved to receive the drug, administered as a once-a-week injection that provides systemic, or whole body, treatment to control the painful and disfiguring skin disorder. In addition to a stronger warning labels, Genentech, Inc., San Francisco, makers of Raptiva, must submit a Risk Evaluation and Mitigation Strategy (REMS) to the FDA. The REMS must include a patient-directed Medication Guide and projected timetable for REMS assessment.

The FDA Office of Surveillance and Epidemiology received numerous reports describing serious infection in patients taking Raptiva, some of whom were hospitalized as a result of infection. In some cases, patients died.

The new label will carry research findings of studies involving juvenile mice, scientifically the age equivalent of a human between one and 14 years of age. These findings suggest the risk of permanent immune system suppression when Raptiva is given repeatedly to this age group, evidence that further strengthens the FDA’s approval of this drug only for individuals 18 years of age or older.

As Raptiva suppresses the immune system to suppress psoriasis outbreaks, it also suppresses the entire body’s immune system. By weakening a patient’s natural defense mechanisms in systemic fashion, the risk of developing serious infection and malignancy is increased.

It is by jeopardizing the entire immune system that Raptiva leaves a patient more susceptible to bacterial sepsis, invasive fungal disease, progressive multifocal leukoencephalopathy (PML), viral meningitis, and similar opportunistic infections.

No patient should begin Raptiva therapy before getting all age-appropriate vaccinations and no further vaccinations should be administered during Raptiva therapy. Because the drug suppresses the immune system, the full strength of a vaccination may not be achieved.

Raptiva warning labels also describe the risk of certain potential adverse side effects and directions to both patient and physician should adverse reactions develop.

Source: FDA