Raptiva (efalizumab) is a medication used to treat chronic plaque psoriasis in adults who are also candidates for systemic therapy or phototherapy to treat their condition. Approximately 2.3 million Americans have chronic plaque psoriasis, which is the most common type of psoriasis.
The U.S. Food and Drug Administration (FDA) approved Raptiva in 2003 to treat plaque psoriasis. Raptiva was given to patients as a once-weekly injection. In the ten years since its approval in the United States, Raptiva has been used to treat over 46,000 patients worldwide. Although plaque psoriasis can be painful and unsightly, it is not a fatal condition, and medications to treat the condition should not put patients at an unreasonable risk of death or permanent disability. Unfortunately, that is exactly what Raptiva did.
If you or a loved one has suffered disability or you have lost a loved one due to side effects of Raptiva use, the pharmaceutical litigation attorneys at Farah & Farah may be able to help you get compensation for the losses you’ve suffered. For a free consultation, fill out a contact form today. In the mean time, it would be helpful to have important information concerning the issues associated with Raptiva.
Concerns About Raptiva Use
The FDA first raised concerns about Raptiva use in October 2008. The FDA issued its warning letter amid concerns that Raptiva use increased the risk of developing progressive multifocal leukoencephalopathy (PML). PML is a rare, progressive disease of the central nervous system that causes severe disability or death in patients who have it. The recall was based on three known cases of PML in patients who were taking Raptiva, as well as a third case in which a patient taking Raptiva died of unknown causes after developing the symptoms of a progressive neurological disease.
In February 2009, the FDA issued a Public Health Advisory about Raptiva after confirming the reports linking Raptiva use to PML. In addition to highlighting the PML risk, the Advisory noted that other serious infections, including sepsis, meningitis, and invasive fungal diseases had also been linked to Raptiva use. The risks of these infections were linked to the fact that Raptiva works by suppressing the immune system, exposing patients to an increased risk of catching various diseases.
The Advisory noted that the patients who had developed PML had all been taking Raptiva for more than three years, and none had any prior neurological complaints or were taking any other medication that might cause suppression of the immune system. PML infections are rare, and there is no known cure.
In March 2009, the manufacturers of Raptiva added a warning about the risks of PML to the drug’s packaging, exhorting doctors to carefully weigh the risk of a PML infection against the relief the medication could give patients with plaque psoriasis.
In April 2009, the FDA and the manufacturer of Raptiva, Genentech, Inc., issued a voluntary recall of the drug. By that time, drug regulators in Europe and Canada had also recommended that Raptiva be pulled from pharmacy shelves due to the connections to PML. Raptiva has not been available for sale or use in the United States since 2009; at that time, it was estimated that 2,000 patients in the United States were receiving the medication.
In 2011, at least one lawsuit was filed alleging that a patient developed Hodgkin’s lymphoma, a type of cancer, from longstanding Raptiva use. However, neither the FDA nor Genentech have released additional warnings linking Raptiva to the development of Hodgkin’s lymphoma or any other type of cancer.
Contact our Pharmaceutical Litigation Attorneys for Legal Help
Although Raptiva has been recalled and has not been available for use, there are many people who may still be at risk of suffering illness as the result of previous use. If you are concerned about your or a loved one’s health and well-being or are curious about what legal options may be available to you, feel free to call our personal injury lawyers for more information at 877-245-6707.