Celexa Warning Label Update: Potential Risk of Abnormal Heart Rhythms

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In addition to having the potential to cause a large number of severe birth defects, Celexa (generic: citalopram) has also recently been associated with potentially dangerous electrical abnormalities of the heart in certain users. The U.S. Food & Drug Administration (FDA) is updating its dosing and warning recommendations for Celexa to accurately reflect this risk. Celexa belongs to a controversial class of potentially-dangerous antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

What’s the problem?

March 28, 2012 – The FDA issued a press release today stating that it was in the process of clarifying dosing and warning recommendations for the widely-prescribed SSRI antidepressant Celexa. In August 2011, the administration warned that Celexa should no longer be used at doses greater than 40 mg per day because it could cause potentially dangerous heart rhythm abnormalities. Due to the risk of QT prolongation, Celexa use at any dose is now discouraged in patients with the following conditions:

  • congenital long QT syndrome
  • bradycardia
  • hypokalemia
  • hypomagnesemia
  • recent acute myocardial infarction
  • uncompensated heart failure

Celexa labels have been updated with information describing the particular caution that needs to be taken when the drug is used in patients with these conditions. The new warning label also describes lower doses that should be used in patients over the age of 60.

Additionally, the FDA is recommending a maximum dose of 20 mg per day of Celexa in patients:

  • with hepatic impairment
  • who are older than 60 years of age
  • who are CYP 2C19 poor metabolizers
  • who are taking concomitant cimetidine (Tagamet) or another CYP2C19 inhibitor
These factors may lead to increased blood levels of Celexa, increasing the risk of QT interval prolongation and Torsade de Pointes.

Celexa Birth Defects

In addition to having the potential to cause potentially-dangerous heart rhythm abnormalities in users, Celexa may also cause the following birth defects in babies born to mothers who take the drug during pregnancy (especially during the first trimester, a time when many women may still be unaware they are pregnant):

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