Tysabri, Raptiva and Progressive multifocal leukoencephalopathy (PML)
Biogen Idec Inc. and Elan Corp.'s multiple sclerosis drug Tysabri has been linked to 31 cases of a deadly brain infection and eight deaths since it returned to the market in 2006, according to U.S. regulators. Tysabri, an intravenous infusion given every four weeks, was cleared for sale in 2004, and temporarily recalled in February 2005 after the drug was linked to progressive multifocal leukoencephalopathy, or PML, infections.
Genentech's Raptiva, approved in 2003 to treat plaque psoriasis in adults, which had carried a "black box" warning on its label relating to progressive multifocal leukoencephalopathy (PML) and other potentially fatal infections including bacterial sepsis, viral meningitis and invasive fungal disease, has been removed from the market – the manufacturer had determined that the fatal risks of the drug outweighed its benefits. The Raptiva label included warnings regarding the risk of permanent suppression of the immune system after repeat administration in children and adolescents but it will no longer be prescribed to patients for psoriasis.
PML was once a very rare brain disease, but with the development of the class of immuno-suppressants called Biologics, of which Raptiva is one, the prevalence of the disease has increased. Raptiva comes in the form of a weekly injection, which can be self-administered at home, and works by suppressing the immune system to such an extent that fewer flare-up of psoriasis occur. However, any time the immune system is compromised in this way, the risks of many types of infection, including fatal ones, are dramatically increased. Thus, the very mechanism of the drug that helps to provide relief of psoriasis flare-ups is the one that causes the dangerous side-effects.
In the case of PML, the debilitating brain infection stems from a virus that is present but dormant in close to 80% of healthy adults. Unfortunately, once the immune system has been suppressed, the normally latent virus may be activated and becomes increasingly life-threatening. The infection steadily worsens, attacking multiple locations in the brain simultaneously, until the patient dies. There were two reported cases of patients taking Raptiva who began having progressive neurological symptoms, though only one definitively diagnosed with PML, that led Genentech to seek approval for the enhanced warning label. The most common presentation of PML includes visual problems, loss of coordination, and other mental impairment. Raptiva should be immediately discontinued if a patient begins to experience such symptoms. Immediate recognition of the symptoms is vital in order to slow the progression of the illness. Sadly, delaying the progression is all that can be done to treat a patient with PML, as there is no cure for the infection at this point in time.
Raptiva's withdrawal from the market should not come as a surprise to those familiar with the class of drugs known as Biologics. Along with Tysabri, Rituxan, another drug by Genentech, was also found to be associated with PML and now carries a warning to that end. Therefore, it is only surprising that Genentech has waited several years to recognize the same inherent side-effect in its immuno-suppressant Raptiva, when it is merely another drug of the same class.
At Pogust Braslow & Millrood, protecting our clients is our primary goal. We recognize that drug companies are under an obligation to warn about the known risks of their products. When they fail to do so, they may be held responsible for the injuries or deaths that are the consequence of their inaction. In addition, doctors may be responsible when they prescribe a medication for an unapproved condition and the patient suffers a serious side effect.
If you or a member of your family has developed a serious infection while taking Raptiva, you should immediately contact the attorneys at Pogust Braslow & Millrood, where Protecting Consumers Is Our Primary Goal. Just fill out this form, click here to send us an email or call us at (610) 941-4204.
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