Raptiva

Baltimore, Maryland

The Food and Drug Administration asked Genentech, Inc. to add a black box warning to their psoriasis drug Raptiva in October, 2008. This was in response to a link found between the drug and a deadly brain infection known as progressive multifocal leukoencephalopathy (PML). On February 19, 2009, the FDA announced that four cases of IPL were most likely caused by Raptiva.

PML is a very serious condition that kills nearly 80 percent of those diagnosed with it in the first six months. Those who survive will most likely have a variety of neurological disorders.

Raptiva was approved in 2003 and has become one of the most widely used drugs to treat moderate to severe cases of plaque psoriasis. Psoriasis is the result of an immune system disorder caused by a type of white blood cell called T cells to trigger inflammation in the skin. This inflammation raises patches of red skin. These patches may be scaly, itch, and burn. Raptiva suppresses the T cells and can keep psoriasis in check with an injection given weekly.

Risks associated with Raptiva include:

• Bacterial sepsis
• Invasive fungal disease
• Viral meningitis
• Progressive multifocal leukoencephalopathy

Raptiva side effects include:

• Burning or problems urinating
• Congestion
• Cough
• Chills or fever
• Sore throat

The FDA has said symptoms to look for include:

• Anemia – jaundice, dizziness, general feeling of weakness
• Nervous system disorders – weakness or tingling in face or limbs, or a sudden onset of numbness
• Thrombocytopenia (low platelet count) – small purple or red dots beneath the skin, bruising, bleeding gums

While European health officials have asked patients to completely stop using Raptiva, the FDA has said the risks do not outweigh the benefits of the drug and have therefore not yet called on doctors to stop prescribing it. They have simply issued a public alert asking health providers to let patients know about the potential risks of PML, as well as the black box warning. They have also asked health providers to monitor Raptiva patients for signs of PML and have asked patients to speak with their doctors prior to stopping their injections of the drug.

If you or a loved one has become sickened by Raptiva, please contact the experienced defective drug attorneys at The Yost Legal Group. We serve the Baltimore, Maryland area.