The FDA has reduced the recommended maximum of the selective serotonin reuptake inhibitor arrhythmias and a lack of healing advantage associated with high doses.
Formerly, the agency had approved a 60-mg/day dose of the antidepressant for certain patients.
The new dosing instruction was prompted by post-marketing surveillance reports plus a trial linking the 60-mg dose to an unacceptable impact on the heart’s electrical activity and Torsade de Pointes (a scarce variety of ventricular tachycardia).
“As an outcome of this extensive study, FDA has decided that Citalopram … should no more be used at doses above 40 mg per day,” the agency said in a drug safety communication.
Bradyarrhythmias, congestive heart failure, and predispositions to magnesium or potassium deficiencies are risk factors for Torsade de Pointes, the FDA noted.
Consequently, the agency recommended that regular electrocardiography should be undergone by patients with one of these illnesses if given Citalopram, and hypokalemia and hypomagnesemia should be corrected before starting patients on the drug.
Patients now taking Citalopram at doses higher than 40 mg/ day should not stop the drug abruptly, but should speak with their physicians about lowering the dose, and really should seek treatment promptly for shortness of breath, irregular heartbeats, fainting, or dizziness.
Package inserts for Citalopram, which can be accessible generic types, will undoubtedly be rewritten to include the advice that was brand new, the agency said.