From: "Express Scripts Clinical Program Management (BLM)"

Date: Fri, 9 Sep 2011 11:47:16 -0500

Subject: URGENT! EMERGING THERAPEUTIC ISSUES COMMUNICATION

Recently, the U.S. Food and Drug Administration (FDA) and Forest Laboratories announced that Celexa® (citalopram) should no longer be used at doses greater than 40mg per day because it can cause abnormal changes in the electrical activity of the heart. In addition, studies did not show a benefit in the treatment of depression at doses higher than 40mg per day. FDA’s guidance is as follows:

  • Citalopram should no longer be prescribed at doses greater than 40mg per day.
  • Citalopram should not be used in patients with congenital long QT syndrome.
  • Electrocardiogram (ECG) monitoring is recommended in patients with congestive heart failure, bradyarrhythmias, or patients on concomitant medications that prolong the QT interval.
  • Hypokalemia (low potassium levels) and hypomagnesemia (low magnesium levels) should be corrected before administering citalopram. Electrolytes should be monitored as clinically indicated.
  • For more information, please contact Forest Laboratories, Inc.'s Medical Information Department at 1-800-678-1605 ext. 66297 from 8:30 am – 6:00 pm EST, Monday through Friday. Full prescribing information can also be found at www.celexa.com

 Express Scripts’ Response:

  • In an effort to inform prescribers of this safety concern, Express Scripts has identified those who have prescribed citalopram with calculated daily doses of greater than 40mg within the past 120 days. A communication summarizing the program changes, including patient profiles, will be sent to prescribers.
  • These communications will be distributed for those clients enrolled in the physician mailing portions of the Emerging Therapeutics Intervention Program.