FDA Watch List: Adcetris
Seattle Genetics’ Hodgkin’s lymphoma medication Adcetris (Brentuximab vedotin) has found its way onto the Food and Drug Administration’s “Adverse Event Reporting System” list for Q3 2011 amid concerns that it could be a dangerous drug that can lead to the development of progressive multifocal leukoencephalopathy.
According to the U.S. National Library of Medicine, progressive multifocal leukoencephalopathy is a rare disorder that damages myelin, the material that protects nerves located in the brain’s white matter. It is primarily caused by the JC virus, and most commonly affects those who have an immune system that has been weakened.
The AERS list documents potential safety risks that were gathered during the final three months of 2011. In January, The FDA approved changes to the Boxed Warning and Warnings and Precautions sections of Adcetris’ labeling to better reflect the potential PML risks associated with it
It is important to note that the FDA has not yet determined whether or not products listed on the AERS watch list pose a health risk. Instead, it means that additional studies will be undertaken to see if there is a link between the product and a potential health risk. Possible regulatory responses, such as a change in the product’s labeling or a recall, could be pursued by the FDA if such a link is found.
If you or a loved one has been harmed by a dangerous drug, there are legal actions at your disposal. Call Sokolove Law to learn more about pursuing a dangerous drug lawsuit today at (877) 490-6520.