Psoriasis Drug Associated With Three Deaths

The FDA has issued a public health advisory following the deaths of three patients using the psoriasis drug efalizumab, which is marketed as Raptiva.

The agency said in its Feb. 19th advisory that there have been three confirmed reports — and one possible case — of progressive multifocal leukoencephalopathy, or PML, in adults using the drug since it was approved in 2003. All four patients, who ranged in age from 47 to 73, had been treated with efalizumab for more than three years; none of them had received other treatments that suppress the immune system while taking the drug.

Three of the patients — two with confirmed PML and one with possible PML — died.
The FDA announced in mid-October that it was requiring labeling changes, including a boxed warning, to highlight the risks of life-threatening infections, such as PML, associated with the use of efalizumab. At that time, the FDA directed Genentech, which manufactures efalizumab, to develop a risk evaluation and mitigation strategy for the drug that would include a medication guide to educate patients about the drug’s risks.

The agency said in its February 19th advisory that it is reviewing this latest information and will take steps to “ensure that the risks of Raptiva do not outweigh its benefits, that patients 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.”

Efalizumab is a weekly injection approved for adults with moderate to severe plaque psoriasis. The drug suppresses a patient’s immune system to reduce psoriasis flare-ups. However, suppressing the body’s defense system can increase the risk of serious infections.

An opportunistic infection caused by the JC virus (so-named for the patient, John Cunningham, in whom it was first isolated) or PML affects the central nervous system in immunosuppressed people, leading to an irreversible decline in neurologic function and death. The FDA advisory said there is no known effective preventive measure or treatment for PML, and there is no laboratory screening test for the disease.

In addition to symptoms of PML (e.g., confusion, dizziness, difficulty talking or walking, vision problems), patients taking efalizumab should be educated on how to recognize symptoms of anemia (e.g., dizziness on standing, weakness, jaundice), thrombocytopenia (e.g., bruising, bleeding gums, petechiae), or a worsening of their psoriasis or arthritis.

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