It appears that while the U.S. FDA is making the boxed warning label stronger and deciding what to do about Raptiva, the European Medicines Agency is ahead of the curve and already recommending suspending the marketing of Raptiva.
Maybe that is what happens when an agency is not in the pocket of the pharmaceutical drug lords.
According to the EMEA, Raptiva's benefits are modest and the risks outweigh their benefits. In addition the rare brain disorder PML, Raptiva has other serious side effects such as Guillain-Barré and Miller-Fisher syndromes, encephalitis, encephalopathy, meningitis, sepsis, and other opportunistic infections for people with compromised immune systems.
The EMEA's committee reviewed Raptiva after receiving reports of serious side effects associated with the drug. These included three confirmed cases of a rare brain infection called PML (progressive multifocal leukoencephalopathy) reported between September 2008 and January 2009 in patients who received Raptiva for more than three years. Two of these cases resulted in the patient death. The committee also received reports of a suspected case of PML which could not be confirmed and another suspected case which was later judged to be unlikely.
The committee concluded that the risk of PML, which is usually fatal, is unacceptable in patients receiving Raptiva for a skin disorder that is rarely fatal.
The EMEA's recommendation has been sent to the European Commission for the adoption of a legally binding decision.
Patients who are now being treated with Raptiva should not stop taking Raptiva abruptly but consult with their doctors to discuss a treatment replacement. People who have taken Raptiva should be closely monitored for neurological symptoms and signs of infection.
Do you or a loved one have a PML Raptiva lawsuit? Find out if you are eligible for justice.
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