The FDA has received reports of three confirmed cases and one possible case of progressive multifocal leukoencephalopathy (PML) in patients who were 47 to 73 years of age who were using Raptiva for the treatment of moderate to severe plaque psoriasis.
Two of the patients with confirmed PML and one patient with possible PML died. All four patients were treated with Raptiva continuously for more than three years. None of the patients were receiving other treatments that suppress the immune system while taking Raptiva.
PML is a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. When PML occurs, it is usually in people whose immune systems have been severely weakened and often results in an irreversible decline in neurologic function and death. There is no known effective treatment for PML.
In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva.
Patients using Raptiva should:
Be aware that Raptiva increases the risk of developing PML. PML is a disease that is fatal or causes severe disability.
Talk with their healthcare provider about the benefits and risks of treatment with Raptiva.
Be aware of the symptoms of PML which may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and sometimes personality changes.
Contact their healthcare provider immediately if they experience these symptoms.
Understand that there are no laboratory screening tests for PML or medical interventions that can prevent or treat PML
The FDA asks health care providers and patients to report possible cases of PML to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html.
RAPTIVA,a medicine given by injectionused to treat adult patients (18 years or older) with moderate to severe plaque psoriasis, may cause life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.
The FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight these risks.
In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.
Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.
Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.
This release comes at a time when we await the Supreme Courts decision on Wyeth v. Levine that could determine whether federal regulation can block patients from suing drug makers in state courts. The question before the court is whether the Food and Drug Administration’s approval of drug labels should knock out state lawsuits that contend the labels did not contain adequate warnings.