According to the US Food and Drug Administration (FDA), 2 additional cases of progressive multifocal leukoencephalopathy (PML) have been reported with the lymphoma drug Adcetris (brentuximab vedotin).
Due to the serious nature of PML, a new boxed warning highlighting this risk has been added to the drug label.
In addition, a new contraindication warning against use of Adcetris with bleomycin due to increased risk of pulmonary toxicity has also been added to the drug label.
The signs and symptoms of PML 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. These signs may develop over the course of several weeks or months. If PML is suspected, healthcare professionals should hold Adcetris dosing. If a diagnosis of PML is confirmed, healthcare professionals should discontinue Adcetris.
Source: FDA.