More Studies Examine SSRI and Birth Defects

Seattle, WAMore studies are now underway to determine the link between certain types of antidepressants, known as selective serotonin reuptake inhibitors (SSRIs), and birth defects.

Currently, The Yale Pink and Blue Study is being conducted to determine the association between depression, anti-depressant use during pregnancy, and the risk of delivering a preterm infant or a low birth-weight baby. Babies born with low birth weights may be at risk for further developmental problems as they age.

In an interview online (at Amazing Pregnancy Secrets), Dr. Kimberly Yonkers, who is overseeing the study, spoke about the importance of information regarding antidepressants during pregnancy: "Women need to know what the risks are, and we as doctors need to provide people with information...specially people on anti-depressants. They are the ones who are going to benefit from this medical knowledge." The study examines women who take Category C serotonin reuptake inhibitors, meaning those whose effect on newborn babies is uncertain. This includes Zoloft, Prozac, and Celexa. It does not include Paxil because Paxil is a Category D drug, meaning that it can harm an unborn baby.

The study is important because there is a lack of knowledge about the effects that drugs have on pregnant women. A study published in 2002 in OB/GYN showed that over 90% of drugs approved between 1980 and 2000 have not been properly tested to ensure they do not cause birth defects if taken by pregnant women. New drugs must be tested to determine whether or not they cause birth defects in pregnant animals before the FDA approves them for use; however companies have no incentive to follow up after drugs are approved.

It has been almost a year since the US Food and Drug Administration issued its alert to healthcare professionals regarding the use of SSRIs during pregnancy. The alert warned that women taking SSRIs after the 20th week of pregnancy were six times more likely to have infants with persistent (or primary) pulmonary hypertension (PPHN), than women who did not take SSRIs during pregnancy. As a means of comparison, PPHN occurs in the general population at a rate of one to two infants per 1000 live births.

According to the alert, the FDA was continuing to gather data from other sources in order to determine what the risk of taking SSRIs during pregnancy is to newborn babies.

The drugs included in the warning were:

Celexa (citalopram)
Fluvoxamine
Lexapro (escitalopram)
Paxil (paroxetine)
Prozac (fluoxetine)
Symbyax (olanzepine/fluoxetine)
Zoloft (sertraline)

Babies born with PPHN require immediate help with their breathing. Even with help, between 10 and 20 percent of babies born with PPHN die shortly after birth. Those who survive often develop other problems including hearing loss, seizures, and brain abnormalities. Other problems associated with taking SSRIs late in pregnancy include withdrawal symptoms, neurologic symptoms, and cardiac symptoms. Of the 60 infants observed in one study, 69% of all SSRI exposed newborns that were developed after a full term had some sort of symptoms. Of the SSRI-exposed infants that were premature, 100% had some form of symptom.

Another concern about SSRIs is that they are being prescribed for off-label uses. Those uses include pain, restless leg syndrome, dementia and even shyness! In addition to concerns about SSRIs, the use of Paxil (also an SSRI) during the first trimester of pregnancy has been linked to an increased risk of cardiac birth defects.

If you took an SSRI while pregnant and delivered a baby with birth defects, you may be eligible for compensation. Contact a lawyer to discuss your options.