Genentech and FDA Announce New Black Box Warning for Raptiva
It was announced yesterday that Raptiva, a drug used to address psoriasis, has received a black box warning (the highest warning a drug can get) that taking of the drug increases the risk for certain viral and bacterial conditions. The new warning highlights increased risk for sepsis, viral meningitis, and other potential serious infections.
According to the FDA's press release regarding this label change:
Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.
For further discussion of this new warning and the reasons for it, see Pharmalot's discussion of this label change.
