FDA Video: SSRI Antidepressant Birth Defects
Below is an excellent video produced by the U.S. Food & Drug Administration (FDA), which warns patients and physicians of serious, life-threatening birth defects linked to SSRI antidepressants.
Read the Full Transcript: SSRI Antidepressant Birth Defects
Congenital Heart Defects
The U.S. Food & Drug Administration has warned doctors and patients that exposure to SSRI’s such as Lexapro during pregnancy pose a serious risk to the fetus and has been linked to an increased risk of Congenital Heart Defects.
More specifically, the most common form of Lexapro induced heart birth defects observed by our firm has been either Atrial Septal Defects or Ventricular Septal Defects.
Persistent Pulmonary Hypertension of the Newborn (PPHN)
Recently, The New England Journal of Medicine released the results of a case-controlled study wherein SSRI’s including Lexapro were linked to an increased risk of an infant being born with Persistent Pulmonary Hypertension of the Newborn (PPHN).
Shortly after the aforementioned study was released, the FDA issued another Public Health Advisory warning that exposure to Lexapro during pregnancy posed a serious risk to the fetus and was linked to an increased risk of PPHN.
Abdominal & Cranial Birth Defects
According to information released from the National Birth Defects Prevention Study of Infants, SSRI antidepressants like Lexapro may cause two separate congenital abnormalities called Omphalocele and Craniosynostosis.
Omphalocele is a congenital (present at birth) abdominal wall defect at the base of the umbilical cord (umbilicus); the infant is born with a sac protruding through the defect which contains small intestine, liver, and large intestine.
Craniosynostosis is a congenital (present at birth) defect that causes one or more sutures on a baby’s head to close earlier than normal. Sutures are connections that separate each individual skull bones. The early closing of a suture leads to an abnormally shaped head.
Known Lexapro Side Effects
- Birth Defects
- Congenital Heart Defects, Atrial or Ventricular Septal Defects (hole in heart)
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Abdominal Birth Defects / Omphalocele
- Cranial Birth Defects / Craniosynostosis
Forest Labs Investigated for Deceptive Marketing
According to a document released by the U.S. Senate’s Special Committee on Aging in 2009, Forest Labs wasted no time in aggressively marketing Lexapro after it was approved. The document details the company’s plans to compensate physicians and psychiatrists for prescribing Lexapro. As a result of these findings, the Justice Department accused Forest of:
- Marketing Lexapro for unapproved uses
- Failing to disclose negative results from clinical trials
- Paying kickbacks to doctors who prescribed the drug
In 2010, the company’s subsidiary, Forest Pharmaceuticals, agreed to pay over $313 million to settle the charges.
Judge Dismisses Suit in Lexapro Marketing MDL
A lawsuit against Forest Pharmaceuticals has been thrown out, and another had a state law claim trimmed, in the ongoing multidistrict litigation (MDL) accusing the company of marketing Lexapro and Celexa to children, even though the antidepressants had not been approved for that purpose. On Dec. 14, 2014, U.S. District Judge Nathaniel M. Gorton ruled that Allied Services Division Welfare Fund, New Mexico UFCW unions and Employers Health and Welfare Trust Fund knew about Forest’s allegedly illegal marketing of Lexapro and Celexa since at least 2009, and that their March 2014 lawsuit is invalid due to statute of limitations (SOL) concerns.