FDA adds new label warnings for antidepressant citalopram

March 28, 2012

FDA added new label warnings for the antidepressant citalopram (Celexa, Forest Laboratories), discouraging patients with certain conditions from using the drug and lowering the dosage recommendations to 20 mg daily for patients aged 60 and older. The warning is also applicable to generic versions of Celexa.

FDA added new label warnings for the antidepressant citalopram (Celexa, Forest Laboratories), discouraging patients with certain conditions from using the drug and lowering the dosage recommendations to 20 mg daily for patients aged 60 and older. The warning is also applicable to generic versions of Celexa.

In August 2011, the maximum recommended daily dose by FDA was 40 mg for all patients.

The new warning recommends citalopram not be used by patients who have the following: congenital long QT syndrome, bradycardia, hypokalemia, or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure. Also, the agency advises to not use for patients who are taking other drugs that prolong the QT interval.

The maximum recommended dose is now 20 mg per day for patients 60 and older, patients with hepatic impairment, patients who are CYP 2C19 poor metabolizers, or patients who are taking concomitant cimetidine (Tagamet) or another CYP 2C19 inhibitor.

According to FDA, patients taking citalopram:

• Should not stop taking the drug or change dose without talking to healthcare professional.

• Should seek immediate care if you experience an irregular heartbeat.

• Should report any side effects to the FDA MedWatch program.