FDA adds more warnings to antidepressant's label

FDA adds more warnings to antidepressant's label
Celexa dosing should not exceed 40 mg a day, agency says.

(HealthDay) -- 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 , including a potentially deadly arrhythmia known as Torsade de Pointes.

Patients at high risk include those with preexisting heart conditions (including ) 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 , bradycardia, hypokalemia, hypomagnesemia, recent heart attack, or uncompensated .
  • Use of the Celexa is also not recommended in patients who are taking other drugs that prolong the .
  • 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.
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.

add to favorites email to friend print save as pdf

Related Stories

FDA announces new limits on high-dose simvastatin (Zocor)

Jun 09, 2011

The United States Food and Drug Administration (FDA) today announced new limitations to the use of high-dose simvastatin, due to the increased risk of muscle pain and weakness (myopathy) and in rare cases, kidney damage and ...

Recommended for you

FDA OKs Cubist antibiotic for serious infections

12 hours ago

The Food and Drug Administration has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May.

Xtoro approved for swimmer's ear

Dec 18, 2014

(HealthDay)—Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat swimmer's ear, clinically known as acute otitis externa.

Drug interaction identified for ondansetron, tramadol

Dec 18, 2014

(HealthDay)—In the early postoperative period, ondansetron is associated with increased requirements for tramadol consumption, according to a review and meta-analysis published online Dec. 10 in Anaesthesia.

New system targets germs in donated blood plasma

Dec 17, 2014

(HealthDay)—A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.