FDA Issues Warning Recommendations for Celexa

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FDA Issues Warning Recommendations for Celexa

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According to the U.S. Food and Drug Administration, high doses of Celexa (citalopram hydrobromide), an antidepressant, might cause dangerous abnormalities in the electrical activity of the heart. Celexa is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).
The Celexa drug label has been altered to contain the caution that intake should be discouraged in patients with certain underlying heart conditions. The revised label also advises that lower doses be taken in patients over the age of 60. For those patients over the age of 60, the maximum recommended dose of Celexa is now 20 mg per day.
Electrical activity changes of the heart can lead to the risk of fatal abnormal heart rhythm. Due to this risk, health care providers might need to regularly monitor the heart in patients that use Celexa. The FDA safety communication states, “Changes in the electrical activity of the heart (specifically, prolongation of the QT interval of the electrocardiogram [ECG]) can lead to a risk of an abnormal heart rhythm called 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 having low levels of potassium and magnesium in the blood.â”

Patient Information from the FDA:

Do not stop taking Celexa or change your dose without talking to your healthcare professional. Stopping Celexa suddenly can cause withdrawal effects.
If you are currently taking a Celexa dose greater than 40 mg per day, talk to your healthcare professional.
Seek immediate care if you experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking Celexa.
If you are taking Celexa, your healthcare professional may occasionally order an electrocardiogram (ECG, EKG) to monitor your heart rate and rhythm.
Your healthcare professional may also order tests to check levels of potassium and magnesium in your blood.
Read the Medication Guide for Celexa carefully and discuss any questions you have with your healthcare professional.
Report any side effects you experience to the FDA MedWatch program using the information in the “Contact FDA” box at the bottom of the page.

For more information, visit the Food and Drug Administration website at http://www.fda.gov.
Source: FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses; 3-28-2012.

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