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Raptiva Can Cause Progressive Multifocal Leukoencephalopathy (PML)
A public health advisory was recently issued by the U.S. Food and Drug Administration (FDA) regarding the psoriasis drug, Raptiva. This health advisory follows three confirmed and one possible report of progressive multifocal leukoencephalopathy (PML), which is a rare brain infection. According to the FDA, three of those patients have died and all four patients were treated with Raptiva for more than three years.
PML results from a virus that affects the central nervous system, which consists of the brain and spinal cord. This potentially fatal disease typically occurs in patients who have weak immune systems. PML is deadly, as it leads to an irreversible decline in neurological function and damages or inflames the white matter of the brain. Symptoms of PML include the following:
• Weakness
• Loss of Coordination
• Vision Changes
• Personality Changes
• Difficulty Speaking
Raptiva is a drug used to treat psoriasis, which is “a chronic, non-contagious autoimmune disease which affects the skin and joints. It commonly causes red scaly patches to appear on the skin.” There are various treatments available for psoriasis, besides Raptiva, which include the drugs cyclosporine, acitretin and methotrexate. Other treatments include approved biologic agents and ultraviolet therapy.
In October 2008, Raptiva’s labeling was revised to include a boxed warning of the risks of life-threatening infections, including PML. During that same time, the FDA instructed Genentech, the drug manufacturer, to create a risk evaluation and mitigation strategy, which would be included in a medication guide designed to educate patients about Raptiva’s risks.
Raptiva is prescribed as a once-a-week injection that is approved for adults with moderate to severe plaque psoriasis. These patients had to be candidates for systematic therapy or phototherapy. Raptiva suppresses T-cells in the immune system, which are blood cells that help fight off infection. By suppressing the T-cells, inflammation caused by psoriasis should go down. However, when T-cells are suppressed, the chances of a patient developing an infection increases.
If you have taken Raptiva, you need to be carefully monitored by your physician for any signs of neurological disease, including PML. Contact the experienced Florida mass tort attorneys at the Law Offices of Lilly, O'Toole & Brown, LLP at (863) 683-1111 to review your case for free.
The FDA is currently working to ensure that the risks of Raptiva do not outweigh its benefits and that patients who have taken Raptiva are thoroughly informed of the symptoms of PML. In addition the FDA is taking steps to make sure that health care providers are carefully monitoring patients who have been prescribed Raptiva, in order to identify the development of PML.
Lilly, O'Toole & Brown, LLP
Lakeland Office: (863) 683-1111
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Also providing legal assistance to clients from:
Wauchula, Lake Placid, Avon Park, Plant City, Brandon, and Valrico, Florida.
