Safety Issues Prompt FDA Changes to Psoriasis Drug Label

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Safety Issues Prompt FDA Changes to Psoriasis Drug Label

Health.com - New York,NY*

By Theresa Tamkins

http://news.health.com/2008/10/17/safety-issues-prompt-fda-changes-

to-psoriasis-drug-label/

FRIDAY, Oct. 17 (Health.com) — The U.S. Food and Drug Administration

(FDA) announced Thursday that it has updated the label for the

psoriasis drug Raptiva to reflect the fact that the drug may

increase the risk of life-threatening opportunistic infections.

Known as a boxed warning, the new label notes that Raptiva

(efalizumab) can increase the risk of bacterial sepsis, an infection

of the bloodstream; viral meningitis, which affects the brain;

invasive fungal infections, which can damage the lungs or other

areas of the body; and a condition known as progressive multifocal

leukoencephalopathy (PML), a viral infection of the brain.

Several people taking Raptiva have been hospitalized and some have

died due to these infections, according to the FDA.

The symptoms of PML include confusion, dizziness, vision problems,

or difficulty talking or walking, the federal agency said. Other

signs that require immediate medical attention include dizziness or

weakness; abnormal bruising or bleeding gums; numbness or weakness

in the arms, legs, or face; or worsening of psoriasis or arthritis.

In addition, animal studies have suggested that the drug may cause

permanent suppression of the immune system in children. The drug is

not approved for use in children under 18. The animal research was

conducted in mice equivalent to ages 1 to 14 in humans.

The drug, administered as a once-a-week injection, was approved in

2003 and treats psoriasis by suppressing the immune system. Patients

should receive all their vaccinations before starting treatment and

they should not be given vaccines during treatment.

Raptiva is approved to treat moderate to severe plaque psoriasis in

adults who would otherwise be candidates for phototherapy or

systemic therapy.

" As part of FDA's monitoring of the life cycle of approved products,

the agency received reports of serious infections in some patients

taking Raptiva. These reports led to our decision to highlight these

risks in the drug's labeling, " said Janet Woodcock, the FDA's

director of the Center for Drug Evaluation and Research, in a

statement.

" Doctors and other prescribers should carefully evaluate and weigh

the risk/benefit profile of Raptiva for patients who would be more

susceptible to these risks. "