Citaprolam (Celexa) Changes in Recommendations (FDA)

[Retired]

Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms
Drugs.com
March 28, 2012

FDA is clarifying dosing and warning recommendations for the antidepressant Celexa (citalopram hydrobromide; also available in generic form). In August 2011, FDA issued a Drug Safety Communication (DSC) stating that citalopram should no longer be used at doses greater than 40 mg per day because it could cause potentially dangerous abnormalities in the electrical activity of the heart. Citalopram use at any dose is discouraged in patients with certain conditions because of the risk of QT prolongation, but because it may be important for some of those patients to use citalopram, the drug label has been changed to describe the particular caution that needs to be taken when citalopram is used in such patients. The revised drug label also describes lower doses that should be used in patients over 60 years of age.

BACKGROUND:
Celexa (citalopram hydrobromide; also available in generic form) is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).

RECOMMENDATIONS:

• Citalopram is not recommended for use at doses greater than 40 mg per day because such doses cause too large an effect on the QT interval and confer no additional benefit.
• Citalopram is not recommended for use in patients with congenital long QT syndrome, bradycardia, hypokalemia, or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure.
• Citalopram use is also not recommended in patients who are taking other drugs that prolong the QT interval.
• The maximum recommended dose of citalopram is 20 mg per day for patients with hepatic impairment, patients who are older than 60 years of age, patients who are CYP 2C19 poor metabolizers, or patients who are taking concomitant cimetidine (Tagamet) or another CYP2C19 inhibitor, because these factors lead to increased blood levels of citalopram, increasing the risk of QT interval prolongation and Torsade de Pointes.

See the FDA Drug Safety Communication for additional recommendations for healthcare professionals and patients.

 

[kjoy82]

I am on 40 mgs per day. And have had no problems with it .

 

[Retired]

kjoy,

....and most people won't have problems as long as they do not have conditions that contained in the revised cautions.

Important to note is that advisory regarding potential drug/drug interaction:

patients who are taking concomitant cimetidine (Tagamet) or another CYP2C19 inhibitor, because these factors lead to increased blood levels of citalopram

While cimetidine is the classic example of a CYP2C19 inhibitor, a liver enzyme responsible for metabolizing certain compaounds, there are dozens of medications that fall into the same category. Anyone taking citalopram would be advised to check with their pharmacist an/or doctor to review all the medications (prescribed, over the counter and alternative preparations) to ensure there are no interactions that might affect the blood levels of their medication(s).