WebMD Medical News
Brunilda Nazario, MD
(Editor's note: On April 8, 2009, Genentech announced it was
voluntarily pulling Raptiva from the market.)
Feb. 19, 2009 -- The FDA today issued a public health advisory about reports
of a rare brain infection in people using the psoriasis drug Raptiva.
According to the FDA, there have been three confirmed and one possible case
multifocal leukoencephalopathy (PML) in people taking Raptiva; three of
those people died.
All four had been treated with Raptiva for more than three years. None was
taking other treatments that suppress the immune system.
The FDA is reviewing the reports of PML in Raptiva users and says it will
take appropriate steps to ensure that Raptiva's risks do not outweigh its
benefits, that patients prescribed Raptiva are clearly informed of PML's signs
and symptoms, and that health care professionals carefully monitor patients on
Raptiva and those who have discontinued the drug for any signs of PML.
PML is caused by a virus that affects the central nervous system. PML
usually occurs in people whose immune systems have been severely weakened. It
leads to an irreversible decline in neurologic function and death.
PML symptoms may include unusual weakness, loss of coordination, changes in
vision, difficulty speaking, and
Raptiva is a once-weekly injection for adults with moderate to severe plaque
psoriasis who are candidates for systemic (whole body) therapy or phototherapy.
Raptiva suppresses T-cells, which are part of the immune system, to curb
psoriasis. Suppressing T-cells increases a patient's susceptibility to
October 2008, Raptiva's label got a "black box" warning -- the FDA's
sternest warning -- about the risk of life-threatening infections, including
Raptiva is made by Genentech. In an email to WebMD, Genentech spokeswoman
Tara Cooper says, "We take the risk of PML very seriously and are working
diligently 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."
SOURCES:News release, FDA.WebMD Health News: "
Psoriasis Drug Raptiva Gets FDA Warning."Statement from Tara Cooper, spokeswoman, Genentech.
The Health News section does not provide medical advice, diagnosis or treatment. See additional information.