Massachusetts Personal Injury Library

FDA Warns About Psoriasis Drug

A recent Boston Globe article announced that the Food and Drug Administration and European Medicines Agency warned consumers that a drug psoriasis medicine called Raptiva was linked to four cases of a deadly brain infection.

According to the article, there have been three confirmed cases and one possible case of progressive multifocal leukoencephalopahy in patients taking Raptiva; three of those patients died.

The FDA, issued a public health advisory concerning Raptiva because of the connection to the rare brain infection. PML is caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. There is no known effective prevention or treatment.

According to the FDA, Raptiva has been used as a treatment for psoriasis, a chronic disease for which there are several effective treatments. The other treatments recommended by the FDA include four other approved biologic agents, ultraviolent light therapy, and the drugs cyclosporine, acitretin, and methotrexate. Usually the treatment for psoriasis patients will involve a rotation of different therapies.

Last October 2008, the FDA recommended the product labeling for Raptiva be revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug's risks.

This recent health advisory is more strongly worded. The FDA strongly recommends that health care professionals discontinue using Raptiva, carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurological disease. Health care providers should make patients aware of the symptoms of PML and contact their health care professionals immediately if they experience any of the symptoms of PML.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for whole body therapy or phototherapy. The drug works by suppressing T-cells (blood cells that help fight infection) in the immune system. These cells, when activated, migrate to the skin and cause inflammation which results in the red, inflamed and scaly patches of skin, which is associated with psoriasis. By suppressing T-cells, Raptiva decreases the function of the immune system which increases a patient's susceptibility to infections.

Health care professionals and consumers may report serious side effects or product quality problems with the use of Raptiva to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

Consumers who want to report a reaction to Raptiva or find more information can contact the Federal Drug Administration, can go to:

–Online: http://www.fda.gov/MedWatch/report.htm
–Fax: (800) FDA-0178
–Phone: (800) FDA-1088