New information recently released by the FDA has brought considerable attention to the side effects associated with the cancer drug, Adcetris, which is manufactured by drug firm Seattle Genetics. The FDA approved Adcetris in August 2011 as a treatment for Hodgkin lymphoma, previously called Hodgkin’s disease, and a rare type of non-Hodgkin lymphoma called systemic anaplastic large cell lymphoma (ALCL). Recent reports, however, have indicated that Adcetris patients may be at risk of developing progressive multifocal leukoencephalopathy (PML), a potentially fatal viral disease that severely affects brain function. If you took Adcetris and have since experienced one or more symptoms indicative of the brain infection PML, contact an Adcetris attorney to discuss your legal options.
Progressive multifocal leukoencephalopathy, or PML, is a rare but extremely serious brain infection that usually results in death. The viral disease is caused by the John Cunningham (JC) virus, and is characterized by progressive inflammation of or damage to the white matter of the brain at multiple locations. According to the drug safety communication recently released by the FDA, patients suffering from PML resulting from Adcetris use typically exhibit signs and symptoms like:
According to the FDA, healthcare providers should hold Adcetris treatment if PML is suspected, and discontinue Adcetris if a PML diagnosis is confirmed. Unfortunately, there is no known cure for PML, and the disease usually causes fatality. In some cases, the effects of PML may slow down or stop if the patient’s immune system improves. Although some pharmaceutical drugs have been developed as potential treatments for PML, this research is only preliminary and the side effect risks associated with these medications are significant.
When Adcetris was approved by the FDA in August 2011, it was touted as the first new drug to be approved as a treatment for Hodgkin lymphoma since 1977, and the first cancer drug to be approved specifically for ALCL. At the time of Adcetris’ approval, one case of PML was associated with the medication, and this information was included in the drug’s Warnings and Precautions section. To date, there have been three patients in total who have developed PML during Adcetris treatment. In light of this side effect risk, the FDA issued a drug safety communication on January 13, 2012, warning the public that two additional cases of PML have been reported with the cancer drug Adcetris. The FDA also added a new Boxed Warning to the drug’s label, notifying patients and physicians about this side effect risk.
If you or a loved one has suffered from serious PML side effects, which you believe to be associated with the cancer drug Adcetris, or if your loved one died while taking Adcetris, contact an Adcetris attorney today. You may have grounds to file an Adcetris lawsuit or wrongful death lawsuit against Seattle Genetics in order to pursue financial compensation for your injuries, medical bills, loss of income, and pain and suffering. Drug companies are responsible for the safety of their medications, and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies intentionally withhold dangerous drug information in an attempt to avoid negative consequences, such as a drug recall. With the help of a qualified Adcetris lawyer, victims of serious PML side effects can ensure that their legal rights are protected while they pursue the financial compensation they deserve.