FDA Orders Genenteck to Display Black Box Warning on Raptiva Label
On October 16, 2008, the FDA notified healthcare professionals of extensive Raptiva labeling changes, including a Black Box Warning about the risks of life-threatening infections with Raptiva use. A Black Box Warning is the FDA’s strongest health warning, signifying that a particular drug carries a significant risk of serious, or life-threatening, side effects.
The Raptiva Black Box Warning will highlight the risk of several different infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy (PML), and other opportunistic infections.
In addition to the Black Box Warning, Raptiva’s prescribing information will be updated to describe the potential risk of permanent immune system suppression when Raptiva is repeatedly administered to children. Raptiva is not approved for children less than 18 years of age.
Raptiva, which has the generic name efalizumab, is a prescription medication used to treat moderate to severe psoriasis. Raptiva is administered as an injection once a week and may be injected into the thigh, abdomen, upper arm, or buttocks. Manufactured by Genentech Inc., Raptiva has been on the market since it received FDA approval in 2003.
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 Raptiva patient who developed PML. Genenteck also said that Raptiva may have contributed to the onset of the disease. A second 62-year-old Raptiva patient developed progressive neurological symptoms and died of unknown causes.
PML is a rare and usually fatal viral infection that is characterized by progressive damage or inflammation of the brain at multiple locations. PML infection occurs almost exclusively in people with severe immune deficiency, such as patients on immunosuppressive medications (e.g. Raptiva), or AIDS patients.
PML is caused by a virus called the JC virus, which is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. Symptoms of PML include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled.
Injured By Raptiva?
If you or a family member developed serious side effects after using Raptiva, you may be entitled to compensation for your injuries. Contact us today for a free and confidential case evaluation.
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