FDA limits Celexa (Citalopram) usage to doses under 40mg per day

I’d like to discuss strategies to ensure patient safety in the inpatient environment following the Food and Drug Administrations’ recently announced dosage limitations for Celexa.

As you may know, earlier this week the FDA, through a Drug Safety Communication, issued a stark warning that the popular anti-depressant should not be used at doses above 40mg per day.  The concern is that changes in the electrical activity of the heart, seen as prolongation of the QT interval of the electrocardiogram, or ECG can lead to an abnormal heart rhythm, including Torsade de Pointes, which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood. 

According to an FDA podcast released yesterday, the citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes.

From a clinical drug monitoring perspective, many clinical pharmacy programs utilize a combination of formulary control, medical staff education, prospective and retrospective drug utilization evaluation monitoring and real-time interventions in order to maintain safe use of drugs.  The best practice recommendation for hospitals then is to first ensure all prescribers and clinicians are aware of the new prescribing limitation.  Using real-time email/text/fax broadcast is the most efficient means to assure this.  Hospitals that do not have a standardized, well understood infrastructure for communicating information that impacts prescribing might be well served by taking this opportunity to develop such a process.

Next, clinical pharmacists should take the opportunity to remind physicians and nurses on patient care areas and patient entry points (ER, OR, Day Surgery, etc) of the new requirements.  Pharmacy and physician order entry systems as well as barcode medication administration applications hould be updated to provide warnings when a dose greater than 40mg is entered or scanned for administration.  Finally, automated analytics, reports and alerts for Citalopram and related medications should also be updated to capture attempts to enter or order high doses so that follow up dialogue and education can be targetted at those prescribers that feel a need to prescribe a now unapproved dose of Citalopram.  Sharing this analytics data with Physician Leadership, Quality and Risk Management in the appropriate reporting forum will allow the organization to determine if additional strategies should be employed to ensure appropriate prescribing.   JH, RPh

Links and Resources:

1)  FDA Drug Safety Communication: Celexa (Aug 24, 2011)

2)  ASHP Pharmacy News: High Citalopram Doses Increase Risk for Heart-Rhythm Abnormality

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