Prozac's Increased Risks of Birth Defects

(May 25, 2012) – Prozac (fluoxetine) is included in a group of medications called Selective Serotonin Reuptake Inhibitors (SSRIs) that work by boosting serotonin levels in the brain, resulting in the regulation of mood, sleep and appetite.  These SSRIs have been linked to serious side effects. Among the reported Prozac side effects are an increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN), congenital heart defects and withdrawal symptoms. Prozac is an anti-depressant used to treat major depressive disorder, bulimia nervosa, obsessive-compulsive disorder, premenstrual dysphoric disorder (PMDD) and panic disorder.

According to researchers, pregnant women who take anti-depressants such as Prozac increase the risk of birth defects in their babies by more than half.  In addition, women using SSRIs in the first 12 weeks of pregnancy, when many women maybe unaware that they are pregnant, were at a 40 percent greater risk of their baby suffering malformation. The risk of heart defects was 60 percent higher. The study, conducted by researchers in the U.S. and Denmark, compared 1,054 women who took SSRIs during the first 3 months of pregnancy with 150,000 women who were not prescribed them.

The FDA approved Prozac in 1998 and it became the most widely prescribed drug for depression on the market. However, two years before the FDA’s approval, a 1996 study published in the New England Journal of Medicine found that women taking Prozac during pregnancy were twice as likely to deliver a baby with three or more “minor abnormalities” and poorer than average neonatal adaption.

Almost a decade later, in 2005, a Danish study indicated that pregnant women who take SSRI anti-depressant medication in early pregnancy may have an increased risk of giving birth to an infant with heart problems. In this study, infants exposed to SSRI anti-depressants during the first three months of pregnancy had a 60 percent higher chance of developing a heart problem compared with infants whose mothers did not take SSRI anti-depressants.

On July 19, 2006, the FDA released a warning that SSRI anti-depressants can cause serious or life-threatening lung problems in newborns whose mother took the medication while pregnant. The warning came after a study was published in New England Journal of Medicine that showed infants were six times more likely to suffer 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 increased 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 PPHN 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 the medication. They also warn that Prozac can be transferred to an infant through breast milk.

Information released from National Birth Defects Prevention Study of Infants, SSRI anti-depressants like Prozac may cause two separate congenital abnormalities called omphalocele and craniosynostosis.

Omphalocele is a congenital (present at birth) abdominal wall defect at the base of the umbilical cord; the infant is born with a sac protruding through the defect, which contains small intestine, liver and large intestine.

Craniosynostosis is a congenital defect that causes one or more sutures on a baby’s head to close earlier than normal. The early closing of a suture leads to an abnormally shaped head.

Although depression is a serious condition, the proven birth defects caused from these SSRI medications are dangerous and should not be taken lightly. If these manufacturers are aware all the side effects these drugs cause, changes must be made.  Giving birth to a baby with such serious health problems is a major trade off to living without depression for nine months. Some women cannot live without these SSRIs and only the patient and their doctor know what is best for them, but for those that can manage without the drugs during pregnancy, it seems like the wise choice.

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