There's a new alert out on popular psoriasis drug Raptiva (efalizumab) after four people died while taking it. They all developed the fatal neurological infection, PML, which regulators believe the drug triggered.
PML (progressive multi-focal leukoencephalopathy) didn't come up as a problem in any of the safety trials carried out on the drug, which was approved in 2003 for treating moderate to severe plaque psoriasis.
However, America's drug regulator, the Food and Drug Administration (FDA), last year ordered Genentech, Raptiva's manufacturer, to include a prominent warning on all labelling about a possible risk of PML.
The FDA has received three confirmed deaths, and one likely death, from PML among Raptiva patients. All four were aged between 47 and 73 years, and none were taking any other treatment that may have suppressed their immune system.
Existing Raptiva patients have been told to report any signs of unusual weakness, loss of coordination, vision problems, difficulties in speaking or personality changes, as all of these are early symptoms of PML.
There are no screening tests for PML, and there are no treatments for it, either.
(Source: FDA website).