Celexa Citalopram HBr Label Change and Risk of Arrhythmia

Users of Celexa (Citalopram Hydrobromide), including cardiologists and psychiatrists, have been alerted by the FDA of the drug safety notice on Celexa (Citalopram Hydrobromide).

There have been certain changes in the drug label with regards to recommendations, as well as changes in the associated risks which have been seen to include Arrhythmia.

Celexa Citalopram Hydrobromide

Background of Celexa (Citalopram Hydrobromide)

The drug Celexa (Citalopram Hydrobromide) is classified as an antidepressant drug that can be found also in its generic version.

It is identified as an SSRI which is the Selective Serotonin Reuptake Inhibitor class of antidepressants.

FDA Alert on Celexa (Citalopram Hydrobromide)

The alert on Celexa (Citalopram Hydrobromide) covers the drug safety notice for identified changes in the following:

• Dosages of the drug
• Warning on side effects of the drug
• Recommendations for usage of the drug

In the month of August in 2011, the FDA had released a drug safety notice (DSC – Drug Safety Communication) on the drug Celexa (Citalopram Hydrobromide).

The DSC on Celexa (Citalopram Hydrobromide) covered details of changed dosages such that the maximum intake had been changed to a dosage not more than 40mg daily. Failure to this, or taking doses higher than this could result in:

• Dangerous rates of the heartbeat
• Abnormal pulses
• Changes in the heart’s electrical functions
• Arrhythmia

Furthermore, persons with certain health conditions have also been highlighted as major risk factors and such people should not take Celexa (Citalopram Hydrobromide) at whichever dose unless absolutely necessary for the patient’s wellbeing.

In addition to this, the DSC also highlighted the dose changes for users aged over 60 yrs old who should instead take lower dosages of the drug.

These people are those patients at risk of potentially developing QT prolongation and below is a list of those risky conditions:

• QT Syndrome
• Heart Failure (especially if it was not compensated)
• Hypomagnesemia
• Hypokalemia
• Bradycardia
• Acute Myocardial Infarction (especially if recent)

The FDA also provided further additional information with the DSC on Celexa (Citalopram Hydrobromide) whose usage has been linked to Arrhythmia (abnormal heart rate).

FDA Recommendation on Celexa (Citalopram Hydrobromide)

“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.”

Contacting the FDA to report cases with Celexa (Citalopram Hydrobromide)

Any adverse side effects or incidences relating to Celexa (Citalopram Hydrobromide) should immediately be reported to the FDA in the event that a patient or medical professional experiences this.

This should be done by contacting or informing the FDA’s MedWatch Safety Information & Adverse Event Reporting Program through any of the following ways:

• Filling and submitting an online report at: http://www.fda.gov/MedWatch/report.htm
• Download the case reporting form at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
• Dialing 1-800-332-1088 and requesting to get a report form, filling it and returning it to the address indicated on the form
• Faxing the filled-up form to the fax number: 1-800-FDA-0178

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