Label Changes for:

Toprol XL (metoprolol succinate) extended release tablets

March 2010

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 2010

WARNINGS

  • Major Surgery: Avoid initiation of high-dose extended release metoprolol in patients undergoing non-cardiac surgery because it has been associated with bradycardia, hypotension, stroke and death. Do not routinely withdraw chronic beta blocker therapy prior to surgery.

ADVERSE REACTIONS

Clinical Trials Experience
  • Post-operative Adverse Events: In a randomized, double-blind, placebo-controlled trial of 8351 patients with or at risk for atherosclerotic disease undergoing non-vascular surgery and who were not taking beta–blocker therapy, TOPROL-XL 100 mg was started 2 to 4 hours prior to surgery then continued for 30 days at 200 mg per day. TOPROL XL use was associated with a higher incidence of bradycardia (6.6% vs. 2.4% ; HR 2.74; 95% CI 2.19,3.43), hypotension (15% vs. 9.7%; HR 1.55 95% CI 1.37,1.74), stroke (1.0% vs 0.5%; HR 2.17; 95% CI 1.26,3.74) and death (3.1% vs 2.3%; HR 1.33; 95% CI 1.03, 1.74) compared to placebo.
Hide
(web3)