FDA Issues New Boxed Warning and Contraindication for Adcetris
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.
BEFORE YOU POST A COMMENT, please note that this is a site for oncology medical professionals. We encourage you to comment on articles posted on our site, but know that we do not edit or alter comments, and that our site is not gated. However, we do remove comments that contain profanity, personal attacks, advertisements for products, or other inappropriate material; we also remove comments that do not promote useful professional dialogue among members of our primary audience. Patients and members of the general public should note that neither the editors nor the authors of articles respond to questions about health matters; if you have such questions, you are advised to consult your health-care provider.