(Editor's note: On April 8, 2009, Genentech announced it was voluntarily pulling Raptiva from the market.)
Oct. 16, 2008 -- The psoriasis drug Raptiva is getting a "black box" warning, the FDA's sternest warning, about the risk of life-threatening infections including a rare brain infection and meningitis.
The FDA announced that news today. Raptiva's warning will highlight the risk of opportunistic infections including:
- Bacterial sepsis: a blood infection that can affect organs throughout the body
- Viral meningitis: a brain infection
- Invasive fungal disease: fungal infection that can spread throughout the body
- Progressive multifocal leukoencephalopathy (PML): a rare brain infection
Raptiva is given by injection once a week to treat moderate to severe plaque psoriasis in adults who are candidates for systemic (whole body) therapy or phototherapy (light therapy) to control their psoriasis. Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, but suppressing the immune system can raise the risk of serious infections and malignancies.
Raptiva's label will also be updated to include data from studies done on young mice that show a potential risk for permanent suppression of the immune system when given repeatedly in this age group, which the FDA says is equivalent to children up to 14 years old. Raptiva isn't approved for use in children younger than 18.
The FDA ordered Raptiva's "black box" warning and other label changes after receiving reports of serious infections in some patients taking Raptiva, notes Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a news release.
But the FDA acknowledges that those reports, which include one case of PML, don't prove that Raptiva caused any illnesses.
FDA's Advice to Patients
The FDA isn't telling patients to stop taking Raptiva.
"Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to the risks," Woodcock says.
The FDA also urges patients to get up to date on their vaccinations before starting Raptiva, and not to get vaccinations while taking Raptiva, because they may not develop immunity to the vaccination virus.
Patients taking Raptiva should also watch for signs and symptoms of infection, as well as these problems:
- Confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems (possible symptoms of PML)
- Dizziness upon standing, weakness, or jaundice (possible symptoms of anemia)
- Bruising, bleeding gums, pinpoint-sized red or purple dots under the skin (possible symptoms of thrombocytopenia, or low platelet count)
- Worsening of psoriasis or arthritis
- Sudden onset of numbness, tingling, or weakness in the arms, legs, or face (possible signs of a nervous system disorder).
The FDA recommends that patients taking Raptiva seek immediate medical attention for those problems.
Genentech, the drug company that makes Raptiva, says it will issue a letter to doctors and other health care providers detailing the label changes. "We feel it's important that patients and doctors are educated about the signs and symptoms of infections and the other information included in the boxed warning," Genentech spokeswoman Krysta Pellegrino tells WebMD.