Label Changes for:
Lithium Carbonate 150 mg, 300 mg, and 600 mg capsules
October 2011
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) – October 2011
WARNINGS
Unmasking of Brugada Syndrome
- ...the unmasking of Brugada Syndrome [added]
PRECAUTIONS
Information for the Patients
- ...the unmasking of Brugada Syndrome [added]
ADVERSE REACTIONS
Cardiovascular
- ...the unmasking of Brugada Syndrome [added]
