Celexa Heart Risks Result in New FDA Warnings

Federal drug regulators are expanding on warnings over the potential heart risks of Celexa, with new dosing instructions aimed at helping the elderly and people with liver problems who still need to take the drug. 

The FDA issued a new Celexa drug safety communication on March 28, setting a maximum recommended dose of 20 mg for patients over the age of 60. The limit is also recommended for patients with liver problems, who are taking the heartburn drug Tagamet, or who are poor CYP2C19 metabolizers or are taking a CYP2C19 inhibitor.

Celexa (citalopram hydrobromide) belongs to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). It was originally created in 1989 by Lundbeck, and is approved for the treatment of major depression.  However, it is often used off-label to treat other psychological disorders. Celexa is available in brand name form or as a generic in 10 mg, 20 mg and 40 mg tablets, as well as a 10 mg/5 mL oral solution.

The dosing recommendations are a detailed expansion of an FDA warning in August of Celexa side effects that could disrupt the rhythm of the heart. The agency stated then that Celexa should no longer be given at doses exceeding 40 mg per day.

The FDA warned patients who are currently taking Celexa to talk to their doctor if their dose is greater than 40 mg per day and to seek immediate care if experiencing an irregular heartbeat, shortness of breath, dizziness or fainting.

The original recommendations were aimed at patients with low potassium and magnesium, as well as patients who already had heart rhythm problems. The FDA says it expanded the recommendations because some patients may still need to take Celexa despite the heart risks. The new label change gets rid of the contraindication for people with congenital long QT syndrome, a heart rhythm condition, and replaces the contraindication with a note that the drug is not recommended for them.