Celexa Linked to Serious Birth Defects
Celexa (citalopram) is one of a class of antidepressant drugs called select seritonin reuptake inhibitors (SSRIs). These drugs act on the neurotransmitter seritonin. Imbalances in neurotransmitters are believed to be a cause of clinical depression. Studies conducted on the effects of SSRIs in pregnant women have shown an increased risk of specific birth defects in infants exposed to the drugs during gestation. Read on to learn more about Celexa birth defects.
FDA Approval and Classification
Celexa was FDA approved for treatment of major depressive disorder and anxiety disorders in adults in July of 1998. Developed by the Danish pharmaceutical company Lundbeck in cooperation with the American company Forest Laboratories, the patent expired in 2003 making the drug available through generic sources. Forest Laboratories was the subject of a Department of Justice lawsuit in 2009 for illegal marketing practices and Celexa was one of three drugs named in the government legal action.
Forest Laboratories reached a settlement of $313 million with the DOJ in 2010. Allegations in the DOJ action included paying kickbacks to doctors for prescribing the three drugs and marketing the drugs for off label (not FDA approved) uses.
The FDA has classified Celexa as a Category C drug for pregnant women. Category C drugs may cause fetal injury, but there is insufficient evidence to prove the link between birth defects and use of the drug. Many other SSRIs have been reclassified as Category D drugs. These drugs have been proven to cause an increased risk of fetal injury.
Clinical Studies on Celexa and SSRIs
A study published by the BMJ Group (formerly the British Medical Journal) on June 6, 2009 found that use of an SSRI, particularly citalopram and sertraline, increased the risk of septal heart defects in newborns exposed to the drug in utero. The study did not find any significant increase in other congenital defects between women who used SSRIs during pregnancy and those who did not.
The New England Journal of Medicine published the results of an earlier study in June, 2007 which also found an increased risk of septal heart defects in infants exposed to SSRIs during gestation. The NEMJ study covered the entire class of drugs and did not publish specific findings on Celexa birth defects.
A 2006 study also published in the New England Journal of Medicine found that infants whose mothers used SSRI antidepressants after the 20th week of pregnancy were six times more likely to be born with persistent pulmonary hypertension of the newborn (PPHN), a potentially fatal congenital condition that cannot be diagnosed before birth.
The results of many studies are ambiguous and in some cases, researchers attributed congenital problems of infants born to SSRI users to other factors including maternal age or alcohol and tobacco use. Clinical studies are often funded by pharmaceutical companies which can lead to biases in reported results.
An epidemiological study for the effects of SNRIs on fetal development was published by the Center for Disease Control in 2012. SNRIs are a different, but related, class of antidepressants. Researchers in this study believed that the interference with seritonin absorption caused by the drugs might disrupt embryonic signaling pathways causing birth defects, most notably heart septal defects and craniofacial defects.
Other studies in Canada and Denmark were performed on children who were exposed to SSRIs in utero. The studies indicated that exposed children showed persistent developmental delays when compared to their peers over a 6 year period. There was also an increase in the incidence of autism spectral disorders among exposed children.
The first Celexa lawsuit for birth defects was filed in 2006 by Lacee Shore of Paducah Kentucky on behalf of her infant son Gavin. Ms. Shore took Celexa throughout her pregnancy and Gavin was born on May 2, 2006 with Shone’s Complex, a condition that involves multiple defects of the heart. Gavin had to undergo surgery shortly after birth, and should he survive, he will have to undergo additional surgeries at age 3 and as a teenager. The prognosis for children with Shone’s is poor.
Allegations in the Shore lawsuit include accusations that the manufacturer deliberately downplayed the risks and severity of side effects of Celexa, particularly the risk of Celexa birth defects. Ms. Shore was using another SSRI before becoming pregnant and switched to Celexa believing it was safer for her baby.
Information on the number of pending Celexa birth defects lawsuits is not available, but new legal actions are being filed as more people become aware that their child’s birth defects may have been caused by antenatal exposure to the drug.
Free Case Evaluation
If you took Celexa during your pregnancy and your child was born with a neural tube defect (anencephaly, craniosyntosis, spina bifida), septal heart defect, or abdominal defect (omphalocele, gastroschisis) you may be entitled to compensation for medical bills, lost income and other expenses related to your child’s ongoing care. You can get a free case evaluation by completing our brief questionnaire. Our professional staff is available to answer your questions and help you find a Celexa birth defect lawyer to handle your claim.