Thursday, April 23, 2009

Unsafe Drug Alert - Raptiva Withdrawn From Market

Raptiva is used to treat psoriasis, an autoimmune disease affecting the joints and causing scaly red patches and psoriatic plaques to appear on the skin.

Raptiva is given by weekly injection to adults treat moderate to severe plaque psoriasis by suppressing the immune system. Although suppressing the body’s immune system is known to increase the risk of serious infection, the Food and Drug Administration ("FDA") approved Raptiva in October 2003.

On October 16, 2008, Raptiva received the FDA’s strongest "black box" warning regarding risk of life threatening infections including bacterial sepsis, viral meningitis, and invasive fungal disease.

On February 19, 2009, the FDA issued an advisory linking Raptiva with rare progressive and fatal brain infection multifocal leukoencephalopathy ("PML") which affects the central nervous system causing irreversible neurologic impairment and death. PML symptoms include weakness on one side of the body, blurred or loss of vision, fatigue, memory loss, disorientation, and loss of balance.

The FDA’s advisory identified 3 confirmed - - and 12 potential - - PML cases following long term (i.e., more than 3 years) treatment with Raptiva.

On April 8, 2009, Raptiva’s manufacturer Genentech withdrew Raptiva from the U.S. market announcing that: "{P}hysicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving Raptiva to assess the most appropriate treatment alternatives."

If you or anyone you know is a Raptiva user and experiencing any serious infection or PML development, contact us at