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Raptiva Gets Black Box Warning for PML, Other Opportunistic Infections

Oct 17, 2008 | Parker Waichman LLP
Raptiva Drugs

Labeling of the Psoriasis Drug Raptiva Will Now Bear a New Black Box Warning

The labeling  of the psoriasis drug Raptiva will now bear a new black box warning about its association with the deadly brain disease progressive multifocal leukoencephalopathy, or PML, and other life threatening infections.  The Food & Drug Administration (FDA) ordered the black box  after receiving reports of serious infections - including at least one case of PML -  in some patients taking Raptiva.

Raptiva is an injectable drug that was approved by the Food & Drug Administration (FDA) in 2003 to treat moderate to severe plaque psoriasis.  Raptiva works by blocking the activation of certain immune cells called T cells, and the migration of those cells into the skin. However, by suppressing the body's natural defense system, it can also increase the risk of serious infections and malignancies in patients.

According to an FDA press release, the agency has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva.  Earlier this month, Genentech said in a letter to healthcare providers that it knew of a 70-year-old patient who took the drug for more than four years developed PML.  The company said that Raptiva may have contributed to the onset of the disease.  A second 62-year-old Raptiva patient developed progressive neurologic symptoms and died of unknown causes.

PML attacks the brain and central nervous system and is usually fatal.  It is caused by a polyomavirus, called the JC virus. The JC virus is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. .Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled.

Now Required Raptiva Boxed Warning Will Highlight the Risk of Bacterial Sepsis

The now-required Raptiva boxed warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, PML, and other opportunistic infections.  Additionally, Raptiva's label will be updated to include data from juvenile animal studies in mice (age equivalent to a 1-14 year old human). These data indicate a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children under 18 years of age.

According to the FDA, patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Vaccinations should not be administered to patients taking Raptiva because immunity to the vaccination virus may not be conferred.

The FDA also advised that patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.

If any of these signs appear, the FDA warned that Raptiva patients should seek immediate medical attention. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

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