FDA Alert: New information has surfaced linking high doses (40 mg or more per day) of the popular antidepressant Celexa to potentially fatal changes in the electrical activity of the heart. Celexa labels have been changed to include updated dosage and usage recommendations, as well as detailed information about the abnormal heart rhythm risk. Celexa is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs) that includes Paxil, Prozac and Lexapro.
What’s the problem?
August 24, 2011 – The U.S. Food & Drug Administration (FDA) has issued a press release warning that Forest Pharmaceuticals’ best selling antidepressant Celexa should no longer be used at doses greater than 40 mg per day because it can cause prolongation of the QT interval of the electrocardiogram. This can lead to an abnormal heart rhythm condition known as Torsade de Pointes, which can be fatal. Individuals at particular risk for developing heart-related side effects include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.
Torsades de Pointes is a form of polymorphic ventricular tachycardia with prolonged Q-T intervals initiated by a premature ventricular depolarization striking near the apex of a delayed T wave. The condition is characterized by irregular heart rates of 200-250 beats per minute with marked variability in amplitude and direction. Torsades may spontaneously resolve or evolve into full-blown ventricular tachyarrhythmia.
According to the new FDA warning, research has failed to show a benefit in the treatment of depression for Celexa at doses higher than 40 mg per day. The Celexa drug label previously stated that certain patients may require a dose of 60 mg per day, but has been updated in light of the new data. Please see the FDA Drug Safety Communication Data Summary in the link above for more information.
The administration is recommending that Celexa not be prescribed at doses higher than 40 mg per day, and that it not be used in patients with congenital long QT syndrome. Individuals with a history of congestive heart failure, bradyarrhythmias, hypokalemia or hypomagnesemia are at an increased risk for developing Torsades de Pointes.
Celexa Birth Defects
In addition to being linked to an increased risk of abnormal heart rhythms in users, Celexa has also been associated with the following birth defects in children born to mothers who took the drug while pregnant (especially during the first trimester, a time when many women may still be unaware that they are pregnant):
- Atrial Septal Defects (ASD)
- Ventricular Septal Defects (VSD)
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Tricuspid Valve (Ebstein’s Anomaly)
- Mitral Valve Prolapse
- Transposition of the Great Arteries (TGA)
- Transposition of the Great Vessels (TGV)
- Tetralogy of Fallot (TOF)
- Hypoplastic Left Heart Syndrome (HLHS)
- Hypoplastic Right Heart Syndrome (HRHS)
- Tricuspid Atresia
- Aortic Stenosis
- Pulmonary Atresia (PA)
- Patent Ductus Arteriosus (PDA)
- Coarctation of the Aorta
- Truncus Arteriosus
- Tricuspid Valve Stenosis
- Heart Murmur
- Pulmonary Stenosis
- Gastroschisis – abdominal wall defect
- Esophageal Stenosis
- Anal Atresia
- Spina Bifida
The following medications belong to the same class of antidepressants as Celexa:
- Prozac (fluoxetine)
- Lexapro (Escitalopram)
- Symbyax (fluoxetine and olanzapine)
- Wellbutrin (Bupropion)