Psoriasis Drug Raptiva Found Linked To Rare Brain Infection

Filed in archive Consumer Alert , Psoriasis & Skin Diseases on February 20, 2009

The US FDA has recently issued a public health advisory regarding the psoriasis drug Raptiva.

Raptiva - a product of Genentech - is once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy.

Now incident reports have linked Raptiva to progressive multifocal leukoencephalopathy (PML) - a rare brain infection - in patients using the drug. The FDA is now reviewing the said information and 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.

Serious Adverse events (side effects) or product quality problems with the use Raptiva should be reporte to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088