FDA Issues Yet Another Warning Over Celexa Use

FDA Issues Yet Another Warning Over Celexa Use

October 6th, 2011 // 11:58 am @

The FDA has issued a drug safety alert for the antidepressant Celexa (citalopram, also available as a generic), reducing the recommended maximum daily dosage to 40 mg/day. The alert is due to a new study which found the previously recommended higher dose of 60-mg/day can cause abnormal changes in the electrical activity of the heart.

These changes can lead to abnormal heart rhythms (cardiac arrhythmia’s), which can be fatal. Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia (low potassium) or hypomagnesemia (low magnesium) are at higher risk of developing Torsade de Pointes (a rare form of ventricular tachycardia).

Celexa is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class. Celexa is manufactured by Forest Laboratories, Inc.

Recent scientific research has raised a variety of issues related to SSRI use.
SSRIs are psychotropic drugs and are among the most widely prescribed antidepressants. The main indication for SSRIs is clinical depression, but they are frequently prescribed for anxiety disorders, eating disorders, chronic pain and occasionally for PTSD (post traumatic stress).
Common SSRI brands include Prozac, Lexapro and Celexa.

SSRI use Linked to Birth Defects

Research suggests that women who take an SSRI during pregnancy risk having children with serious birth defects. SSRI use has been linked to numerous birth defects, including PPHN, (persistent pulmonary hypertension of the newborn), septal heart defects, anencephaly (a birth defect that affects the brain and skull), omphalocele (a birth defect that affects the abdominal organs) and craniosynostosis (a birth defect that affects sutures on the head).

One study conducted by the Department of Clinical Epidemiology, Aarhus University Hospital, Denmark, reports that women who took an SSRI during the early months of their pregnancy nearly doubled the risk of having children with congenital malformations compared to women who took no SSRIs during their pregnancy.

SSRI use Linked to Autism Spectrum Disorders

A recent study by researchers at Kaiser Permanente reports that exposure to SSRI antidepressants in early pregnancy can increase risk of autism spectrum disorders (ASD).

Researchers of the study, Antidepressant Use During Pregnancy and Childhood Autism Spectrum Disorders, found a doubling in the risk of autism among mothers who had filled a prescription for antidepressants at any point in the year before delivery. The strongest effect was associated with first trimester treatment, said the study’s lead author Lisa Croen, PhD, director of the Autism Research Program at the Kaiser Permanente Division of Research in Oakland,Calif.

She explained that in utero exposure to antidepressant medications was reported in 6.7 percent of cases and 3.3 percent of controls. The population-based, case-control study of 1,805 children is the first to systematically address the association between prenatal SSRI exposure and autism risk.

SSRI use linked to Cataract Risk

Use of selective serotonin reuptake inhibitor (SSRI) antidepressants may be associated with cataract risk among older adults, a large population study from Canada found.

In a nested case-control study involving more than 200,000 residents of Quebec, current users of SSRIs ages 65 and older carried a 15 percent greater relative risk of cataracts (95% CI 0.08 to 1.23) compared with nonusers, reported Mahyar Etminan, PharmD, MSc, of the University of British Columbia in Vancouver, and colleagues.

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