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Celexa containing Citalopram, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class manufactured by Forest Labs. FDA and approved use of Celexa on 17th July 1998 for the treatment of depression. Its off-label uses are Obsessive-Compulsive Disorder, Panic disorder, Premenstrual Dysphoric Syndrome, Anxiety disorders, Post-traumatic Stress Disorder and Eating disorders. Since Celexa entered the market, it is linked to hazardous complications like birth defects and risk of autism in children born to mothers who had taken this drug during pregnancy.
Major complications faced till date:
- Risk of Birth defects including Anencephaly, Craniosynostosis, Omphalocele, Septal defects, Persistent Pulmonary Hypertension (PPHN) etc.
- Increased risk of suicidal thinking and violent behavior
In 2004, Celexa was transferred from Category B to Category C of pregnancy safety criteria, as it indicated higher risk of fetal abnormality.
On 2nd May 2007, FDA proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality in young adults ages 18 to 24.
FDA has recommended to add an information to the package inserts of Celexa that it should not be used at doses greater than 40 mg per day as it causes abnormal changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram can lead to Torsade de Pointes) on 12th August 2011 and revised again on 27th March 2012 with additional warnings on the same.
FDA released safety announcement on 14th December 2011, about the use of SSRI antidepressants by women during pregnancy and the potential risk of persistent pulmonary hypertension of the newborn (PPHN).
Multiple lawsuits have been filed against Forest Laboratories with accusations that it has failed to adequately warn the patients including pregnant women about the dangerous side effects of Celexa and improperly "off-label" marketing to children in spite that it was only approved for adults by FDA. For this, Forest Pharmaceuticals received $150 million criminal fine. There are no post marketing studies conducted to study the birth defects caused by Celexa.
Evidence to be looked for in potential cases
- Usage of Celexa in Pharmacy Records.
- Duration of Celexa usage in pregnant females and in children/young adults from Pharmacy Records
- Diagnosis and Treatment of birth anomalies in child; suicidal tendency and violent behavior in children/young adults after Celexa intake
- Treatment required for birth related defects in child.
Medical Record Review and claim validation of Celexa case should take approximately 2 hours in most instances; however, this approximation may vary in cases based on the volume of records.