CELEXA - Abnormal Heart Rhythms Associated With High Doses - FDA

August 25, 2011

Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses

[Posted 08/24/2011]AUDIENCE: Psychiatry, Cardiology

ISSUE: FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including 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 low levels of potassium and magnesium in the blood.

Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes. See the FDA Drug Safety Communication Data Summary for additional information.

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

RECOMMENDATION: Citalopram causes dose-dependent QT interval prolongation. Citalopram should no longer be prescribed at doses greater than 40 mg per day. Citalopram should not be used in patients with congenital long QT syndrome. Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes. See the FDA Drug Safety Communication for additional recommendations for healthcare professionals and patients. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/24/2011 - Drug Safety Communication - FDA]

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August 25, 2011

Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses

[Posted 08/24/2011]AUDIENCE: Psychiatry, Cardiology

ISSUE: FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including 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 low levels of potassium and magnesium in the blood.

Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes. See the FDA Drug Safety Communication Data Summary for additional information.

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

RECOMMENDATION: Citalopram causes dose-dependent QT interval prolongation. Citalopram should no longer be prescribed at doses greater than 40 mg per day. Citalopram should not be used in patients with congenital long QT syndrome. Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes. See the FDA Drug Safety Communication for additional recommendations for healthcare professionals and patients. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/24/2011 - Drug Safety Communication - FDA]

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August 25, 2011

Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses

[Posted 08/24/2011]AUDIENCE: Psychiatry, Cardiology

ISSUE: FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including 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 low levels of potassium and magnesium in the blood.

Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes. See the FDA Drug Safety Communication Data Summary for additional information.

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

RECOMMENDATION: Citalopram causes dose-dependent QT interval prolongation. Citalopram should no longer be prescribed at doses greater than 40 mg per day. Citalopram should not be used in patients with congenital long QT syndrome. Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes. See the FDA Drug Safety Communication for additional recommendations for healthcare professionals and patients. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/24/2011 - Drug Safety Communication - FDA]

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August 25, 2011

Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses

[Posted 08/24/2011]AUDIENCE: Psychiatry, Cardiology

ISSUE: FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including 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 low levels of potassium and magnesium in the blood.

Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes. See the FDA Drug Safety Communication Data Summary for additional information.

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

RECOMMENDATION: Citalopram causes dose-dependent QT interval prolongation. Citalopram should no longer be prescribed at doses greater than 40 mg per day. Citalopram should not be used in patients with congenital long QT syndrome. Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes. See the FDA Drug Safety Communication for additional recommendations for healthcare professionals and patients. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/24/2011 - Drug Safety Communication - FDA]

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August 25, 2011

How does one withdraw safely from Celexa? Is it OK to cut the dose in half, ie,

from 40mg to 20mg daily, and then to 20mg every other day?

Is Celexa worse for the elderly? More so than any other SSRI?

Years ago, I read that Prozac can cause abnormal changes to the EKG, even at

lower doses, over a long period of time.

Everything I've read indicates these drugs do nothing at all *for* patients, but

rather they do a lot of bad stuff *to* people. It is scary to live in Alice in

Wonderland world, where useless drugs are prescribed and discussed as if they

*help.* (especially if all they do is harm, and are hard to get off of.) Cate

>

> Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal

> Heart Rhythms Associated With High Doses

> [Posted 08/24/2011]

>

> AUDIENCE: Psychiatry, Cardiology

>

> ISSUE: FDA notified healthcare professionals and patients that the

> antidepressant Celexa (citalopram hydrobromide) should no longer be used

> at doses greater than 40 mg per day because it can cause abnormal

> changes in the electrical activity of the heart. Changes in the

> electrical activity of the heart (prolongation of the QT interval of the

> electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including

> 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 low levels of

> potassium and magnesium in the blood.

>

> Studies did not show a benefit in the treatment of depression at doses

> higher than 40 mg per day. Previously, the citalopram drug label stated

> that certain patients may require a dose of 60 mg per day. The

> citalopram drug label has been revised to include the new drug dosage

> and usage recommendations, as well as information about the potential

> for QT interval prolongation and Torsade de Pointes. See the FDA Drug

> Safety Communication Data Summary for additional information.

>

> BACKGROUND: Celexa (citalopram hydrobromide) is in a class of

> antidepressants called selective serotonin reuptake inhibitors (SSRIs).

>

> RECOMMENDATION: Citalopram causes dose-dependent QT interval

> prolongation. Citalopram should no longer be prescribed at doses greater

> than 40 mg per day. Citalopram should not be used in patients with

> congenital long QT syndrome. Patients with congestive heart failure,

> bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia

> because of concomitant illness or drugs, are at higher risk of

> developing Torsade de Pointes. See the FDA Drug Safety Communication for

> additional recommendations for healthcare professionals and patients.

>

> Healthcare professionals and patients are encouraged to report adverse

> events or side effects related to the use of these products to the FDA's

> MedWatch Safety Information and Adverse Event Reporting Program:

>

> * Complete and submit the report Online:

> www.fda.gov/MedWatch/report.htm <http://www.fda.gov/MedWatch/report.htm>

> * Download form

> <http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.ht\

> m> or call 1-800-332-1088 to request a reporting form, then complete

> and return to the address on the pre-addressed form, or submit by fax to

> 1-800-FDA-0178

>

> [08/24/2011 - Drug Safety Communication

> <http://www.fda.gov/Drugs/DrugSafety/ucm269086.htm> - FDA]

> - -

>

August 25, 2011