FDA
Advises Public of Serious Adverse Event with Psoriasis Drug Raptiva
The U.S. Food and Drug Administration
today issued a public health advisory concerning three confirmed, and one
possible report of progressive multifocal leukoencephalopathy (PML), a
rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab).
Three of those patients have died. All four patients were treated with the
drug for more than three years. None of the patients were receiving other
treatments that suppress the immune system.
The FDA is reviewing this latest
information. The agency will take appropriate steps to:
- ensure that the risks of Raptiva do not
outweigh its benefits;
- that patients prescribed Raptiva are
clearly informed of the signs and symptoms of PML; and
- that health care professionals
carefully monitor patients for the possible development 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. Symptoms may include unusual weakness, loss
of coordination, changes in vision, difficulty speaking and personality
changes. There is no known effective prevention or treatment.
Psoriasis is a chronic disease, for which a number of effective
therapeutic options are available, including four other approved biologic
agents, ultraviolent light therapy, and the drugs cyclosporine, acitretin,
and methotrexate. Generally, treatment for psoriasis patients involves a
rotation of therapies.
In October 2008, the product labeling for Raptiva was revised to highlight
in a boxed warning the risks of life-threatening infections, including PML.
At that time, the FDA directed Genentech, the manufacturer, to develop a
risk evaluation and mitigation strategy (REMS) to include a medication
guide to educate patients about the drug’s risks.
The FDA strongly recommends that health care professionals carefully
monitor patients on Raptiva, as well as those who have discontinued the
drug, for any signs or symptoms of neurologic disease, and that they
periodically reassess the benefits of continued treatment. Patients should
be aware of the symptoms of PML and contact their health care
professionals immediately if they experience any such symptoms.
Raptiva is a once-weekly injection approved for adults with moderate to
severe plaque psoriasis who are candidates for systemic (whole body)
therapy or phototherapy. The drug works by suppressing T-cells (blood
cells that help fight infection) in the immune system. These cells, when
activated, migrate to the skin and cause inflammation which results in the
red, inflamed and scaly patches of skin, which is associated with
psoriasis. By suppressing T-cells, Raptiva decreases the function of the
immune system which increases a patient’s susceptibility to infections.
Health care professionals and consumers may report serious adverse events
(side effects) or product quality problems with the use of this product to
the FDA's MedWatch Adverse Event Reporting program online, by regular
mail, fax or phone.
