Psoriasis Drug Raptiva

Manufactured by Genentech, Inc., Raptiva (generic name efalizumab) was approved in 2003, and is an injectable medication given once a week to treat moderate to severe plaque psoriasis in adults who are candidates for systemic (whole body) therapy or phototherapy (light therapy). Raptiva suppresses the immune system to reduce psoriasis flare-ups. However, because the immune system (the body's natural defense system) is weakened as a result, patients using Raptiva run the risk of serious infections and malignancies.

On October 16, 2008, the U.S. FDA (Food and Drug Administration) announced labeling changes to Raptiva, including a "black box" warning, the strongest warning given for a prescription medication. This warning highlighted the risks of the following life-threatening infections:

• Bacterial sepsis: a blood infection that can affect organs throughout the body
• Viral meningitis: a brain infection
• Invasive fungal disease: fungal infection that can spread throughout the body
• Progressive multifocal leukoencephalopathy (PML): a rare brain infection

The FDA is also requiring Raptiva to submit a Risk Evaluation and Mitigation Strategy (REMS) that will include a medication guide for patients and a timetable for assessing the risks. The label will also contain data from juvenile animal studies in mice, with an age equivalency of a 1-14 year-old child. The data shows a potential risk for permanent suppression of the immune system after repeated use of Raptiva in this age group. Raptiva is not approved for children under age 18.

The FDA warns patients taking Raptiva to recognize the following signs and symptoms of infection:

• Confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems (possible symptoms of PML)
• Dizziness upon standing, weakness, or jaundice (possible symptoms of anemia)
• Bruising, bleeding gums, pinpoint-sized red or purple dots under the skin (possible symptoms of thrombocytopenia, or low platelet count)
• Worsening of psoriasis or arthritis
• Sudden onset of numbness, tingling, or weakness in the arms, legs, or face (possible signs of a nervous system disorder)

The FDA warning states that, "If any of these signs appear, Raptiva patients should seek immediate medical attention. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva."

Our firm has worked with countless individuals and families who have been injured by dangerous drugs. If you or a loved one has suffered injury, or a family member has died after taking Raptiva, please fill out our questionnaire to the right of this page for a free consultation.