The FDA has announced that doctors linked a medication used to cure a skin condition to a lethal brain infection.
A public health advisory has been issued as a result confirming three deadly cases of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the drug Raptiva (efalizumab).
The agency is still reviewing the cases, but has outlined three basic steps to ensure patient safety. They require doctors to determine that the risks of taking the drug do not outweigh the benefits, that patients prescribed Raptiva are informed of the symptoms of PML, and that health professionals monitor patients for the disease.
PML causes "an irreversible decline in neurologic function and death," says the advisory, adding that there is no known cure for the disease.
Symptoms include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes.
According to the National Institutes of Health, PML is caused by the reactivation of a common virus in the central nervous system in individuals with a compromised immune system.
Raptiva works by suppressing T-cells in the immune system whose migration to the skin is responsible for the inflammation and scaling associated with psoriasis.