NEWS - Psoriasis drug Raptiva (efalizumab) gets FDA black box warning

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Psoriasis Drug Raptiva Gets FDA Warning

'Black Box' Warning Will Note Risk of Dangerous Infections

By Miranda Hitti

WebMD Health News

Reviewed by Louise Chang, MD

Oct. 16, 2008

The psoriasis drug Raptiva is getting a " black box " warning, the FDA's

sternest warning, about the risk of life-threatening infections

including a rare brain infection and meningitis.

The FDA announced that news today. Raptiva's warning will highlight

the risk of opportunistic 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 is 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.

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.

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.

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Read the entire article here:

http://www.webmd.com/skin-problems-and-treatments/psoriasis/news/20081016/psoria\

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