Navigation Links
FDA Adds More Warnings to Antidepressant's Label
Date:3/28/2012

WEDNESDAY, March 28 (HealthDay News) -- In a follow-up to a warning that high doses of the popular antidepressant Celexa can cause potentially fatal abnormal heart rhythms, the U.S. Food and Drug Administration has issued new dosing and use recommendations.

Last August, the FDA said doses of Celexa (citalopram hydrobromide) greater than 40 milligrams a day can cause changes in the electrical activity of the heart, which can lead to abnormal heart rhythms, including a potentially deadly arrhythmia known as Torsade de Pointes.

Patients at high risk include those with preexisting heart conditions (including congestive heart failure) and those prone to low levels of potassium and magnesium in the blood, the FDA said.

At the time, the drug label was revised to include the new dosage limit as well as information about the potential for abnormal heart electrical activity and rhythms.

The latest recommendations note that Celexa in any dose should not be given to patients with certain conditions due to the risk of suffering these heart problems. However, it may be important for some patients to take Celexa, so the label has been changed to describe the particular cautions required when giving the drug to these patients.

Here are the latest FDA recommendations:

  • Celexa should not be used at doses greater than 40 milligrams (mg).
  • Celexa is not recommended for use in patients with congenital long QT syndrome, bradycardia, hypokalemia, hypomagnesemia, recent heart attack, or uncompensated heart failure.
  • Use of the Celexa is also not recommended in patients who are taking other drugs that prolong the QT interval, a measure of a heart's electrical activity.
  • The maximum recommended dose of Celexa is 20 mg per day for patients with liver impairment, patients who are older than 60, patients who are CYP 2C19 poor metabolizers, or patients who are also taking cimetidine (Tagamet) or another CYP 2C19 inhibitor. All of these factors lead to increased blood levels of Celexa, increasing the risk of QT interval prolongation and Torsade de Pointes, the FDA said.

Dr. Norman Sussman, a psychiatrist at NYU Langone Medical Center and a professor at NYU School of Medicine in New York City, said: "What the FDA's recommendations ultimately mean is that before prescribing, after prescribing and especially when considering starting a new drug, a physician in any specialty who is treating a patient taking citalopram should be certain of the effect the medication may have on the QT interval.

"These recommendations are basically a game changer for the way in which citalopram should be prescribed, and how patients taking citalopram should be monitored," he said.

Celexa belongs to a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs), which also include widely used medications such as Paxil, Prozac and Zoloft.

More information

The American Academy of Family Physicians has more about antidepressants.

-- Robert Preidt

SOURCEs: Norman Sussman, psychiatrist, NYU Langone Medical Center, and professor, NYU School of Medicine, New York City; U.S. Food and Drug Administration, news release, March 28, 2012


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. U.S. Will Push to Have Graphic Warnings on Cigarettes
2. Judge Blocks Plan for Graphic Cigarette Warnings
3. Judge Blocks FDA Plan for Graphic Cigarette Warnings
4. FDA Proposes Graphic Warnings on Cigarette Packs
5. FDA Calls for New Warnings on Some Prostate Cancer Drugs
6. Does the brain remember antidepressants?
7. Moms Antidepressants May Affect Babies Head Size: Study
8. Antidepressants While Pregnant Linked to Slight Risk of Lung Problem in Babies
9. Blood test might predict how well a depressed patient responds to antidepressants
10. Certain Antidepressants With Blood Thinners May Pose Risk for Heart Patients
11. Fear of Antidepressants Keep Many From Disclosing Depression
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... 13, 2017 , ... Dickinson Insurance and Financial Services, a ... services, is providing an update on a charitable event that began earlier this ... a locally recognized nonprofit that provides shelter and care for animals seeking new ...
(Date:10/13/2017)... Pekin, IL (PRWEB) , ... October 13, 2017 ... ... Foundation, which established the certification process to promote standards of excellence for the ... iaedp™ Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , which ... evacuation of the facility as part of a disaster drill on October 3rd. , ... and Shelton City Emergency Manager, as well as the Connecticut Long Term Care ...
(Date:10/13/2017)... ... 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought ... This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at ... towards children of all ages; it is a non-competitive, non-timed event, which is all ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains ... possible to save lost souls in the Philippines. “The Journey: From the Mountains to ... dedicated teacher of the Bible. She has taught all ages and currently teaches a ...
Breaking Medicine News(10 mins):
(Date:10/4/2017)... , Oct. 4, 2017  South Korean-based healthcare product ... training aide "cprCUBE" on Kickstarter. The device will educate ... cardiac arrests with better efficiency compared to the dated ... real-time feedback on efficacy of the compression for a ... has a goal to raise $5,000. ...
(Date:10/2/2017)... , Oct. 2, 2017  AllianceRx Walgreens Prime, ... formed by Walgreens and pharmacy benefit manager Prime Therapeutics ... new brand, which included the unveiling of new signage ... , as well as at a few other company-owned ... new brand to patients, some of whom will begin ...
(Date:9/27/2017)...  Commended for their devotion to personalized service, SMP Pharmacy ... one in the South Florida Business Journal,s 50 Fastest-Growing Companies, ... list, the national specialty pharmacy has found its niche.  To ... soon be honored by SFBJ as the 2017 Power Leader ... to receive his award in October, Bardisa said of the ...
Breaking Medicine Technology: