Paxil

Paxil–one of the most widely-prescribed anti-depressant drugs given to patients suffering from depression, anxiety, and even shyness–has been linked to serious birth defects. The drug–which has been prescribed to Americans since 1992–can cause heart defects in babies whose mothers took the drug during their first three months of pregnancy. Additionally, babies whose mothers took Paxil after the fifth month of pregnancy are at a higher risk of Persistent Pulmonary Hypertension of the Newborn (PPHN), a serious and life-threatening lung condition.

The drug paroxetine–known as Paxil in the U.S., Canada, and several other countries–is a type of drug known as a selective serotonin reuptake inhibitor (SSRI). Manufactured by GlaxoSmithKline, it is considered one of the most potent SSRIs on the market. It has been used to treat depression, post-traumatic stress disorder (PTSD), panic attacks, social anxiety, obsessive-compulsive disorder, premenstrual dysphoric disorder (PMDD), and other anxiety-related disorders.

In March 2004, the U.S. Food and Drug Administration (FDA) started requiring a black box warning on Paxil and other SSRIs because of the risk of suicidal tendencies in children and teenagers taking the drug.

Then in September 2005, the FDA reported findings of a study that linked twice the number of birth defects to Paxil than to other antidepressants taken during the first trimester of pregnancy.

More recently, in February 2006, a study published in the New England Journal of Medicine reported that infants whose mothers took SSRIs after the 20th week of pregnancy were six times more likely to have PPHN than babies whose mothers never took the drugs.

In July 2006, the FDA also issued an alert to healthcare professionals reporting the potential for life-threatening serotonin syndrome in patients taking SSRIs with certain other types of drugs.

Heart Defects and Paxil

The babies of mothers who took Paxil during their first three months of pregnancy are twice as likely as the babies of mothers taking other SSRIs to be born with serious heart-related birth defects. The most common heart malformations are in babies born with holes in the chambers of their hearts, called atrial and ventricular septal defects. These defects can cause serious symptoms and may require surgery.

Persistent Pulmonary Hypertension (PPHN) in Newborns and Paxil

Persistent Pulmonary Hypertension in Newborns (PPHN) is a serious and life-threatening lung condition. Babies with PPHN need immediate help with their breathing; 10% to 20% of babies with PPHN die shortly after birth. Babies who survive are at risk of developing seizures, hearing loss, brain abnormalities, and other conditions.