[Feb. 19, 2009]

FDA Advises Public of Serious Adverse Event with Psoriasis Drug Raptiva. The FDA today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died. All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.

The FDA is reviewing this latest information. The agency will take appropriate steps to:

• Ensure that the risks of Raptiva do not outweigh its benefits;
• That atients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and
• That health care professionals carefully monitor patients for the possible development of PML.

PML is caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. There is no known effective prevention or treatment.

Psoriasis is a chronic disease, for which a number of effective therapeutic options are available, including four other approved biologic agents, ultraviolent light therapy, and the drugs cyclosporine, acitretin, and methotrexate. Generally, treatment for psoriasis patients involves a rotation of therapies.

In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug's risks.

The FDA strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment. Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy. The drug works by suppressing T-cells (blood cells that help fight infection) in the immune system. These cells, when activated, migrate to the skin and cause inflammation which results in the red, inflamed and scaly patches of skin, which is associated with psoriasis. By suppressing T-cells, Raptiva decreases the function of the immune system which increases a patient's susceptibility to infections.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

Raptiva Warnings of Brain Infections & Meningitis

Oct. 16, 2008 -- The FDA announced that the psoriasis drug Raptiva is getting a "black box" warning, due to the risk of life-threatening infections including a rare brain infection and meningitis. Raptiva is a psoriasis medication given by injection once a week to treat moderate to severe plaque psoriasis in adults who are candidates for systemic (whole body) therapy or phototherapy (light therapy) to control their psoriasis.Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, but suppressing the immune system can raise the risk of serious infections and malignancies.

This FDA warning of Raptiva includes the risks of other infections including:

• 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

Raptiva Warning Label to Include Increased Risks for Suppression of Immune System

Raptiva's label will also be updated to include data from studies done on young mice that show a potential risk for permanent suppression of the immune system when given repeatedly in this age group, which the FDA says is equivalent to children up to 14 years old. Raptiva isn't approved for use in children younger than 18.

There Has Not Been a FDA Raptiva Recall Issued

The FDA ordered Raptiva's "black box" warning and other label changes after receiving reports of serious infections in some patients taking Raptiva, notes Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a news release.But the FDA acknowledges that those reports, which include one case of PML, don't prove that Raptiva caused any illnesses. In fact the FDA isn't telling patients to stop taking Raptiva but rather the Raptiva advise or warning is:"Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to the risks," Woodcock says. The FDA also urges patients to get up to date on their vaccinations before starting Raptiva, and not to get vaccinations while taking Raptiva, because they may not develop immunity to the vaccination virus.

Raptiva Side Effects

According to medical experts, patients taking Raptiva should also watch for signs and symptoms of infection and other potentially serious side effects including:

• Cing to medonfusion;
• Dizziness or loss of balance;
• Difficulty talking;
• Difficulty walking;
• Vision problems (possible symptoms of PML);
• 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 and  
• Sudden onset of numbness, tingling, or weakness in the arms, legs, or face (possible signs of a nervous system disorder).

Raptiva Dear Doctor Letter

Genentech, the drug company that makes Raptiva, says it will issue a letter to doctors and other health care providers detailing the label changes. NOTE: The FDA recommends that patients taking Raptiva seek immediate medical attention for any problems that might be associated with this drug.

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