The FDA has issued a public health advisory concerning progressive multifocal leukoencephalopathy (PML) and the psoriasis drug efalizumab (Raptiva).
PML is a rare but serious progressive neurologic disorder caused by a virus that attacks the central nervous system. Patients with a severely compromised immune system are most at risk from suffering from an irreversible brain function and death. No treatment exists for PML.
There have been three reported deaths linked to PML. A fourth case is being looked at as well.
Patients diagnosed with psoriasis suffer from inflamed, red, scaly lesions, caused when affected skin cells reproduce faster than normal.
The product labeling for Raptiva was revised in October 2008 to include a boxed warning the risks of life-threatening infections, including PML.
The FDA advises health care professionals to carefully monitor patients on Raptiva, as well as those that may have discontinued use, for any signs or symptoms of the disease.