Raptiva Linked To Increased Cancer Risk
Psoriasis drug, Raptiva (efalizumab), which was removed from the market in April of 2009, and designed to manipulate the immune cells which cause psoriasis, weakened the immune system of many patients, which left them susceptible to numerous types of infections and cancers.
According to WebMD, in a controlled study, among the 2,762 psoriasis patients who received Raptiva at any dose, 31 patients were diagnosed with 37 malignancies. The overall incidence of malignancies of any kind was 1.8 per 100 patient-years for Raptiva-treated patients compared with 1.6 per 100 patient-years for placebo-treated patients. Malignancies observed in the Raptiva-treated patients included non-melanoma skin cancer, non-cutaneous solid tumors, Hodgkin's lymphoma and non-Hodgkin's lymphoma, and malignant melanoma.
Genentech Pulls Raptiva from the Market Due to Reports of Serious Infection
On April 8, 2009, not long after the FDA announced a black-box warning on Raptiva, Genentech announced a phased voluntary withdrawal of the drug from the U.S. market, due to life-threatening side-effects experienced by numerous patients. Raptiva is a prescription drug used to treat psoriasis, a troubling skin disorder that affects an estimated 7.5 million individuals in the U.S., according to the National Institutes of Health. Raptiva (efalizumab) is a man-made form of a protein similar to human antibodies and is given by injection once a week. Raptiva works by suppressing the immune system, but suppressing the immune system also raises the risk of serious infection.
According to the Food and Drug Administration (FDA), Raptiva can cause many side-effects including bacterial sepsis (blood infection that affects organs), viral meningitis (brain infection), invasive fungal disease (fungal infection that spreads throughout the body), and progressive multifocal leukoencephalopathy (brain infection). Genetech's decision to pull the drug was especially based on the association of Raptiva with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. PML damages the material (myelin) that covers and protects nerves in the white matter of the brain. Symptoms may include memory loss, headaches, loss of language ability, vision problems, and weakness of the legs and arms that get progressively worse.
Genentech estimates 2,000 patients in the United States were receiving Raptiva for plaque psoriasis and since FDA approval in 2003, approximately 46,000 patients worldwide have been treated with the drug. Four cases of PML were reported in plaque psoriasis patients, an incidence of approximately one in 500 treated patients.
February 19, 2009: FDA Issues Public Health Advisory Warning of Possible Brain Infection Among Raptiva Users
On February 19, 2009, the FDA issued a public health advisory about progressive multifocal leukoencephalopathy (PML), a rare brain infection among some users of the psoriasis drug Raptiva (efalizumab). PML is a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened and often results in an irreversible decline in neurologic function and death. There is currently no known effective treatment for PML. PML symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking, and personality changes. In October 2008, a Black Boxed Warning was added to the Raptiva label warning of the risks of life-threatening infections, including PML.
If you or a loved one have experienced PML type symptoms or serious side effects following Raptiva use, and would like additional information, please contact us.
FDA PUBLIC HEALTH ADVISORY BELOW (from fda.gov)
FDA Public Health Advisory
Updated Safety Information about Raptiva (efalizumab)
Since the approval of Raptiva (efalizumab) in October 2003, 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.
Raptiva works by affecting T-cells in the immune system. The effects of Raptiva also decrease the function of the immune system and increase susceptibility to infections.
Raptiva was approved for the treatment of moderate to severe plaque psoriasis in 2003. There were no cases of PML seen in the clinical trials that supported the approval of Raptiva. At the time of approval, a total of 2,764 patients had been treated with Raptiva. Of those 2,764 patients, 2400 had been treated for three months, 904 for six months, and 218 for one year or more.
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.
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.
Healthcare providers should, in the interim, be aware of the following information and advice:
- Raptiva increases the risk of PML. Longer, continuous use may further increase this risk.
- Inform patients using Raptiva of the potential risk of developing PML.
- There are no known screening tests that can reliably predict PML or medical interventions that can prevent or treat this disease.
- Monitor patients being treated with Raptiva for the onset of neurologic symptoms. Discontinue Raptiva if PML is suspected.
- Patients treated with Raptiva should be periodically re-evaluated to ensure that the benefit of treatment continues to outweigh the risks. Consideration should be given to use of other approved therapies to control the patients' psoriasis.
- The effects of periodic or intermittent use of Raptiva, or the concomitant use of other immunosuppressant drugs on the risk for PML is not known.
- 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