Prozac Linked to Birth Defects

As one of the world's leading anti-depressants, Prozac has been prescribed to more than 54 million people worldwide, including pregnant women. Studies have shown, however, that Prozac and other drugs in its class could be linked to serious side effects. Those Prozac side effects include a risk of so-called Prozac birth defects, including heart defects such as transposition of the great arteries, pulmonary stenosis and Primary Pulmonary Hypertension of the Newborn (PPHN).

Prozac (fluoxetine) is a Selective Serotonin Reuptake Inhibitor (SSRI) that is used to treat major depressive disorder, bulimia nervosa, obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD).

On July 19, 2006, the US Food and Drug Administration (FDA) released a warning that SSRI antidepressants can cause serious or life-threatening lung problems in newborns whose mothers took the medication while pregnant. The warning came after a study was published in the New England Journal of Medicine that showed infants were six times more likely to suffer Persistent Pulmonary Hypertension in the Newborn (PPHN) after being exposed to SSRIs such as Prozac. Babies whose mothers took Prozac while pregnant may also suffer withdrawal symptoms such as agitation, poor feeding, and insomnia.

PPHN occurs when the blood vessels in the lungs constrict, causing increasing pressure in the pulmonary artery, possibly resulting in death. Symptoms of PPHN include shortness of breath, chest pain, fatigue, and fainting spells. Many patients with PPH require a lung transplant. Even with treatment 20 percent of newborns with PPHN die. Symptoms of PPHN include rapid breathing and heart rate, difficulty breathing, or bluish skin.

The FDA has placed Prozac in Pregnancy Category C. This means that animal studies have indicated that there is a risk to the fetus, but human studies do not show that the risk of birth defects is greater than the risks involved in discontinuing medication. They also warn that Prozac can be transferred to an infant through breast milk.

In December 2011, the FDA announced that there is no clear causal link between PPHN and the use of SSRIs while pregnant. While two studies suggested a link between the use of SSRIs while pregnant and the development of PPHN, three studies do not support the association. The FDA advises women who are taking antidepressants while pregnant not to stop because there are risks associated with having untreated depression while pregnant.

A study published in the July, 2011 issue of the Archives of General Psychiatry suggests a link between the use of SSRIs in the year prior to delivery and an increased risk of delivering a baby with autism spectrum disorder. According to researchers, when women took an SSRI during the twelve months prior to delivery, the risk of having a baby with autism spectrum disorder doubled. The risk quadrupled when an SSRI was taken during the first trimester of pregnancy.

Prozac and Septal Defect: A septal defect is a hole in the wall of the heart, causing improper blood circulation. This forces the heart to work harder than it should to pump blood. Patients may require open-heart surgery. A study published in the journal Obstetrics & Gynecology (07/11), found that use of fluoxetine while pregnant was associated with an increased risk of isolated ventricular septal defects.

Prozac and Coarction of the aorta: Coarction of the aorta occurs when the aorta is too narrow, causing uneven blood flow throughout the body. This may require medical intervention and/or surgery.

Prozac and Hypoplastic left heart syndrome: Hypoplastic left heart syndrome occurs when the left side of the infant's heart does not develop completely, sometimes resulting in sudden death. Patients may undergo a heart transplant.

Prozac and Pulmonary Stenosis: Pulmonary stenosis involves a narrowing of the pulmonary valve, which results in decreased blood flow to the lungs.

Prozac and Tetralogy of Fallot: Tetralogy of Fallot involves narrowing of the pulmonary valve, large ventricular septal defect, dilated aorta connected to both the left and right ventricles and thickening of the right ventricle. It can result poorly-oxygenated blood moving throughout the patient's body.

Prozac and Transposition of the Great Arteries: Also known as transposition of the great vessels, this occurs when the aorta and the pulmonary artery, which carry blood away from the heart, are switched. Patients may require surgery to recover.

Prozac and Craniosynostosis: Craniosynostosis occurs when the sutures in an infant's skull harden prematurely, which can cause a misshapen skull, intracranial pressure, and a lack of growth in the child's head. A 2007 study, published in the New England Journal of Medicine (06/28/07), found a link between the use of SSRIs during pregnancy and craniosynostosis.

Prozac and Cleft Palate: A cleft palate occurs when the parts of the skull that form the roof of the mouth do not join. This can cause problems with feeding, speech and breathing and can also cause ear infections and hearing loss.

Prozac and Cleft Lip: A cleft lip is a facial defect affecting the infant's upper lip. It can cause delays in speech and language.

Prozac and Club Foot: Club foot occurs when the bones, joints, muscles and blood vessels in an infant's leg and foot develop abnormally causing the foot to be turned inward and downward. This can cause pain and problems with mobility.

Prozac Birth Defects

If your child was born with PPHN, PPH or other birth defect a lawyer may be able to help. Please click the link below to send your Prozac birth defects complaint which will be reviewed by an attorney at no cost to you.
Last updated on Jan-3-12