The Food and Drug Administration on Thursday said Genentech’s psoriasis drug Raptiva has been linked to three deaths from progressive multifocal leukoencephalopathy or PML, a condition known as a side effect of the drug.

 

Raptiva was approved in 2003 for adults with moderate to severe plaque psoriasis. The drug works by suppressing the immune system to reduce psoriasis flare-ups, but, by suppressing the body’s natural defense system, it can also increase the risk of serious infections and malignancies in patients.

 

The Food and Drug Administration added a black box warning to the drug in October, last year, which says it increases the risk of life-threatening infections such as bacterial sepsis, viral meningitis, invasive fungal disease and even PML, a disorder usually seen in patients with immune deficiencies. It is caused by a virus that affects the central nervous system and leads to an irreversible decline in neurologic function and death.

 

Referring to the FDA’s announcement, Genentech spokeswoman Tara Cooper said the company is working with the FDA “to put the right plans in place that will help protect patient safety. We are evaluating all possible approaches to address the risk of PML with Raptiva use, including a risk minimization plan. It is premature to disclose the scope of our plans until we've reached a formal agreement on those plans with the FDA.”

 

The FDA urged health care professionals to carefully monitor patients taking Raptiva and those who have stopped the treatment for any signs or symptoms of neurologic disease. Also patients experiencing weakness, loss of coordination, changes in vision, difficulty speaking and personality changes should address to a doctor right away.