Dr. Weeks’ Comment: What a shame that the FDA approves drugs so easily and that so typically suffering happens after approval resulting in recalls or additional warnings. In this case, a mere 4 months after approval, the warnings of life threatening side-effects are starting.
FDA Issues Warning About Lymphoma Drug Brentuximab
Pulmonary Toxicity Also a Concern
Posted: 01/13/2012
January 13, 2012 ”” The US Food and Drug Administration (FDA) has issued a warning to healthcare professionals about the lymphoma drug brentuximab (Adcetris, Seattle Genetics).
Two new cases of progressive multifocal leukoencephalopathy (PML), which is a rare but serious brain infection, have been reported. Because of the seriousness of PML, which can result in death, a new boxed warning highlighting this risk has been added to the drug label, according to the FDA.
In addition, a contraindication was added, warning against the use of brentuximab with the cancer drug bleomycin because of the increased risk for pulmonary toxicity.
Brentuximab was approved by the FDA in August 2011 for the treatment of Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma. At the time of approval, 1 case of PML was described in the warnings and precautions section of the label. So there are now 3 cases associated with the drug.
The signs and symptoms of PML can develop over the course of several weeks or months. They can 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 FDA says.
Healthcare professionals should suspend brentuximab dosing if PML is suspected, and discontinue the drug therapy if a diagnosis of PML is confirmed, according to the FDA.
Brentuximab generated much excitement among experts when study results were presented at the American Society of Hematology annual meeting in 2010. Some of the responses seen in refractory lymphoma were described as “amazing.” The new drug is the first to be approved by the FDA for Hodgkin’s lymphoma in more than 30 years, the company said.
More information about today’s FDA announcement is available on the agency’s Web site.
To report adverse events related to brentuximab, contact MedWatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online atwww.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.