FDA Adds Raptiva Black Box Warning About Serious Infections

The FDA is adding a new “black box” warning to the psoriasis drug Raptiva. Side effects could include an increased risk of potentially life-threatening infections, including the brain disease progressive multifocal leukoencephalopathy (PML).

 
Raptiva (efalizumab) is a subcutaneous injection administered once a week to treat psoriasis. The drug is a therapeutic antibody designed to block the activation of special immune cells called T-cells. Overactivity of T-cells leads to excess skin cells being produced, which build up in the form of plaques, causing the skin disease psoriasis

The FDA approved Raptiva in October 2003, and it is manufactured and marketed by Genetech, Inc. Worldwide sales were approximately $120 million last year.

On October 16, 2008, the FDA announced that a new Raptiva “black box” warning will be added to the drug’s label to highlight the risk of serious infections which could result from using the drug. This could include opportunistic infections such as bacterial sepsis, viral meningitis, invasive fungal disease and progressive multifocal leukoencephalopathy.

Progressive multifocal leukoencephalopathy or PML is a very serious brain infection which is often fatal. Although it is rare, the progressive disease causes inflammation and deterioration of the central nervous system and the brain, and there is no known cure.

The FDA also indicates that they are requiring the drug’s maker to develop a strategy for reducing the risk of infection among users and to distribute a Medication Guide to patients filling the prescription, which will further highlight the Raptiva infection side effects.

In a statement released by the FDA announcing the warnings, the agency indicated that individuals taking Raptiva should be educated about the signs of infection, PML, anemia, trombocytopenia or worsening of their psoriasis or arthritis. Symptoms could include confusion, dizziness, loss of balance, difficulty walking, difficulty taking, weakness, jaundice, bruising, bleeding gums, red or purple dots under the skin and vision problems.