Pharmaceutical

New warnings placed on SSRI Celexa

The safety label for the antidepressant Celexa will now carry new dosing and warning recommendations that include the risk for potentially dangerous abnormalities in the electrical activity of the heart. The new recommendations advise that doses greater than 40 mg per day should not be used because of the risk for abnormal heart rhythms known as QT prolongation. This condition can increase the risk of Torsades de Pointes, an abnormal heart beat that can be fatal.

Celexa is already discouraged in patients with certain conditions because of the risk for QT prolongation. However, because it is important for some patients with these conditions to use this drug, the label has been changed to inform health care providers the kind of precautions that needs to be taken with these patients. The new label also advises lower dosing for patients who are older than 60.

Celexa, also known by the generic citalopram hydrobromide, is in a class of medications known as selective serotonin reuptake inhibitors (SSRI). Other drugs in this class include Paxil, Zoloft, Lexapro, and Prozac. SSRIs are among the most prescribed drugs in the country, and provide treatment for people who are depressed and/or suffer from anxiety disorders.

New studies on the drugs have put into question their safety during pregnancy. Some recent studies show that using the drugs while pregnant can cause fetuses to develop serious defects of the heart and lungs.

Any side effects with Celexa or any drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA