Side Effects of Paxil Use During Pregnancy Linked to Major Heart Defects: Study

The findings of new research appear to confirm previous links between side effects Paxil and birth defects, indicating that use of the popular antidepressant during pregnancy may increase the risk of children being born with major heart malformations.

In a study published in the January issue of the British Journal of Clinical Pharmacology, researchers from Canada found that using Paxil during the first trimester of pregnancy increased the risk of giving birth to a child with congenital malformations by 23%, and major heart defects by 28%.

Researchers conducted a review of 23 studies published between 1966 and November 2015, looking at the risk of cardiac malformations linked to gestational exposure.

The findings suggest that the risk of major congenital malformations increased by 23% when Paxil was used during the first trimester. They also found a 28% increased risk of major cardiac malformations, particularly bulbus cordis anomalies and cardiac septal closures, which were 47% more likely. However, the highest risks appeared to be linked to atrial septal defects and right ventricular outflow track defects; the risks of which were both doubled when compared to pregnant women who did not use Paxil.

The study comes about seven months after the U.S. Centers for Disease Control and Prevention (CDC) reported that Paxil was linked to an increased birth defect risk for ancephaly, atrial septal defects, right ventricular outflow tract obstruction defects, gastroschisis and omphalocele in a study published in The BMJ in July.

Paxil (paroxetine) is a selective serotonin reuptake inhibitor (SSRI) prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, generating sales of about $1 billion a year.

In December 2005, the FDA issued an alert in the United States about the risk of birth defects from Paxil, after studies showed the drug could increase the risk of the heart defects when taken during the first three months of pregnancy. At that time, the agency also required GlaxoSmithKline to update the warning label in this country to include information about the pregnancy risks with Paxil.

The company has faced hundreds of Paxil lawsuits in the United States, which were brought on behalf of children who suffered various birth defects and malformations, such as persistent pulmonary hypertension in newborns (PPHN) and other health problems. The complaints alleged that Glaxo purposefully hid test results that would have revealed the risks associated with use of Paxil during pregnancy and misled doctors.

In 2010, it was reported that GlaxoSmithKline set aside $2.4 billion to settle Paxil birth defect lawsuits.