The U.S. Food and Drug Administration was recently notified of two more PML cases in which the patient had been taking Adcetris (brentuximab vedotin) to treat their lymphoma. Adcetris, which is manufactured by Seattle Genetics, was approved in August 2011 treat both Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
At the time of its approval, there had only been one case of PML associated with the drug’s usage.
PML is a rare disorder that is primarily brought on by the JC virus, which tends to affect those whose immune systems are already weakened. The disorder damages the body’s myelin, the material that protects nerves located in the brain’s white matter.
According to the FDA, signs and symptoms of PML may not manifest themselves for months They may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body.
The new cases of PML have already spurred the FDA to adjust the drug’s Boxed Warning to better highlight the risk. The drug was also recently named on the U.S. Food and Drug Administration’s Adverse Event Reporting System, which documented drugs with potential safety risks that were noted during the final three months of 2011.
If you or a loved one has been harmed by a dangerous drug such as Adcetris, there may be legal options available to you. Call Sokolove Law today to learn more about pursuing a dangerous drug lawsuit. Call us today at (877) 490-6520.