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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2012
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions, Including Anaphylaxis
- Hypersensitivity reactions, including anaphylaxis and death, have been reported in association with Benlysta. Delay in the onset of acute hypersensitivity reactions has been observed.
- Limited data suggest that patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk.
The following adverse reactions have been identified during postapproval use of Benlysta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Fatal anaphylaxis