Persistent Pulmonary Hypertension in the Newborn (PPHN) and Prozac

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, formerly known as Primary Pulmonary Hypertension of the Newborn) after being exposed to SSRIs such as Prozac.

Persistent Pulmonary Hypertension (PPH) is a serious lung disorder with no obvious cause. PPH occurs when the blood vessels in the lungs constrict, causing increasing pressure in the pulmonary artery, possibly resulting in death. Symptoms of PPH include shortness of breath, chest pain, fatigue, and fainting spells. Many patients with PPH require a lung transplant.

PPHN is a potentially devastating condition that occurs when the blood vessels in the lungs remain constricted, preventing blood from being oxygenated. The lack of oxygen in the blood puts the infant's organs under stress, which then puts the infant at risk of suffering serious complications. Even with treatment 20 percent of newborns with PPHN die. Symptoms of PPHN include rapid breathing and heart rate, difficulty breathing, or bluish skin.

Infants who survive PPHN may suffer permanent problems including difficulty breathing, seizures, developmental disorders, and hearing loss.

The study from the New England Journal of Medicine showed that the risk of serious health problems increased greatly in infants who were exposed to Prozac during the second half of pregnancy. Generally, PPHN occurs in around one or two infants per 1,000 births. However, in newborns exposed to SSRIs during the late stages of pregnancy, six to twelve infants per 1,000 births developed PPHN. Babies whose mothers took Prozac while pregnant also suffer withdrawal symptoms such as agitation, poor feeding, and insomnia.

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.

Prozac PPH or PPHN Birth Defects

If your child was born with PPHN or later developed PPH, 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.