New Raptiva Warnings: Risk of PML Brain Disease
March 1, 2009
UPDATE: The makers of Raptiva have taken this drug off the market due to the risk of PML (Click Here for more recent info on the Raptiva Recall)
FDA has announced a new black box warning (the strongest FDA warning there is) on the psoriasis drug Raptiva after at least three confirmed reports of progressive multifocal leukoencephalopathy (PML).
All three confirmed patients have died.
PML symptoms include: weakness, vision problems, loss of coordination, speech problems, confusion and personality changes. There are no effective treatments or prevention methods for PML.
The FDA is recommending that doctors and nurses carefully monitor any patient who has taken or is currently taking Raptiva. Health professionals are advised to check for signs of neurological disease and inform patients of the risks involved in taking Raptiva.
Raptiva is an injection that is taken once per week to treat moderate to severe plaque psoriasis. Raptiva works by suppressing T-cells in the immune system, which are blood cells that help fight infection. It is thought that Raptiva decreases the function of the immune system, which increases a patient’s risk of serious infections, such as progressive multifocal leukoencephalopathy (PML).
FDA is currently taking steps to determine if the benefits of Raptiva are worth the risk of serious infections, such as PML.
In a recent press release FDA stated clearly in bullet-point format that:
“Raptiva increases the risk of PML. Longer, continuous use may further increase this risk.”
FDA also advised healthcare professional to:
“Inform patients using Raptiva of the potential risk of developing PML.”
What You Should KNOW if You Are Taking Raptiva:
First, be aware of the increased risk of developing PML, and that PML is often fatal. Also understand that there are no known tests that can reliably screen for PML, and there are no known treatments that can treat or prevent the disease.
What You Should DO if You Are Taking Raptiva:
Talk with your doctor about the benefits and risks involved in using Raptiva to treat psoriasis. Contact your doctor immediately if you notice symptoms such as unusual weakness, loss of coordination, changes in you vision, trouble talking or personality changes.
You may also contact the FDA to report side effects related to Raptiva at the following number: (1-800-FDA-1088).
If you or a loved one has developed brain disease or serious infections like progressive multifocal leukoencephalopathy (PML) after taking Raptiva, you may have rights to compensation.
Also see this week’s Black Box warning on the heartburn medication Reglan.
Were you affected? Click Here for a free case evaluation!
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[...] Also see this week’s other FDA Black Box Warning for Raptiva. [...]
[...] Raptiva is a once-weekly injection for adults with moderate to severe plaque psoriasis. See our earlier warning here. [...]
[...] Vision problems, speech problems, weakness, loss of coordination, confusion and personality changes are often symptoms of conditions or diseases such as Progressive Multifocal Leukoencephalopathy (PML) or stoke, but could also be side effects associated with certain medications. PML itself can be a side effect of the drug Raptiva. [...]
[...] Raptiva is used to treat psoriasis by suppressing immune function. It has been linked to a brain infection [...]