The anti-psoriasis drug Raptiva was removed from the U.S. market after it was linked to potentially fatal infections. Government health officials here had previously required a "black box" warning for Raptiva and a European drug agency called for its suspension from the market.
The actions were taken after reports that at least three patients using Raptiva, generically efalizumab, contracted progressive multifocal leukoencephalopathy, or PML, a rare brain infection that is usually fatal. Two of the three patients died.
If you or a loved one suffered severe injury or death due to infection after using Raptiva, you may want to contact a Raptiva attorney.
The drug's manufacturer, Genentech, said it in a letter to doctors and patients that Raptiva would no longer be available in the United States as of June 9, 2009. It said the decision was "based on the association of Raptiva with an increased risk" of PML.
The U.S. Food and Drug Administration in late 2008 had required a "black box" warning for Raptiva concerning PML, bacterial sepsis, viral meningitis, invasive fungal disease and other infections. Raptiva reduces flare-ups of psoriasis by suppressing the immune system, but by doing so it can increase the body’s risk of serious infections and malignancies.
In addition to the FDA action, a committee of the European Medicines Agency (EMEA) in February 2009 recommended that the 24 states in the European Union suspend Raptiva, saying its review of the drug concluded that its benefits "no longer outweigh its risks."
The EMEA’s Committee for Medicinal Products for Human Use cited the three cases of PML, which were reported between September 2008 and January 2009. The infection is caused by a virus commonly found in the general population but only leading to PML in people with weakened immune systems.
The committee also noted other potential side effects, including Guillain Barre and Miller Fisher syndromes, encephalitis (inflammation of the brain), brain damage, meningitis, sepsis and tuberculosis.
The FDA said patients who use Raptiva should seek immediate medical attention if they recognize symptoms of PML such as confusion, dizziness or loss of balance, difficulty talking or walking, or vision problems.
Kline & Specter PC is based in Philadelphia and has some 30 attorneys, several of whom are also highly skilled doctors. The law firm has had success litigating product liability and prescription drug lawsuits in Pennsylvania, New Jersey and nationwide. For a free evaluation of your case, contact a Raptiva lawyer today for a free evaluation of your case.