Label Changes for:
Lidocaine in 5% Dextrose Injection, USP
March 2012
Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2012
WARNINGS
- Anaphylactic reactions may occur following administration of lidocaine hydrochloride. In the case of severe reaction, discontinue the use of the drug.
ADVERSE REACTIONS
Hematologic Effects: methemoglobinemia
- Allergic reactions, including anaphylactic reactions, may occur but are infrequent.
