Celexa

  • Celexa Medical Record Review & Outsourcing Services

Celexa is an anti-depressant (Citalopram) of the selective serotonin reuptake inhibitor (SSRI) class, manufactured by Forest Laboratories. The U.S Food and Drug Administration (FDA) approved the use of Celexa on July 17, 1998, for the treatment of depression. Its “off-label” uses are for Obsessive-Compulsive Disorder, Panic disorder, Premenstrual Dysphoric Syndrome, Anxiety disorders, Post-traumatic Stress Disorder, and Eating disorders. Since Celexa entered the market, it has been linked to hazardous complications like birth defects and risk of autism in children born to mothers who had taken this drug during pregnancy.

In 2004, Celexa was transferred from Category B to Category C of pregnancy safety criteria, as it indicated a higher risk of fetal abnormality.

Serious Alleged Injuries may include:

  • Risk of Birth defects including Anencephaly, Craniosynostosis, Omphalocele, Septal defects, Persistent Pulmonary Hypertension (PPHN), etc.
  • Autism
  • Increased risk of suicidal thinking and violent behavior

FDA Safety Warnings:

All the makers of antidepressant medications were proposed by the FDA on May 2, 2007, to update the existing black box warning on their products’ labels to include warnings about the increased risks of suicidal thoughts and behavior, known as suicidality, in young adults aged between 18 to 24 years, during the initial treatment.

FDA, on August 12, 2011, 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 was linked to abnormal changes in the electrical activity of the heart and prolonging the QT interval of the electrocardiogram during a test was noted to lead to Torsade de Pointes. FDA also sent a letter out on March 27, 2012, for the warning labels to be revised with additional warnings on the same.

FDA released a safety announcement on December 14, 2011, about the use of SSRI antidepressants by women during pregnancy and the potential risk of persistent pulmonary hypertension of the newborn.

Legal Updates:

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 improper "off-label" marketing to children, even though it was only approved for adults by the FDA. For this, Forest Pharmaceuticals was imposed with a $150 million criminal fine in 2010. No post-marketing studies have been conducted to study the birth defects caused by Celexa.

MDL 2067, supervised by US District Judge Nathaniel M. Gorton in Massachusetts was formed against Celexa and Lexapro. Plaintiffs allege that the manufacturer's, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. engaged in the false and misleading promotion of Celexa and Lexapro for pediatric or adolescent use and gained prescriptions from physicians and others by providing them with various forms of illegal remuneration. The plaintiffs further allege that this conduct caused them economic harm.

In March 2014, after over four years of litigation, the parties informed the Court that they had reached a settlement agreement and the defendant, Forest Laboratories, agreed to pay between $7.7 million and $10.4 million.

Evidence:

  • 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 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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