Zoloft has been associated with an increased risk of birth defects in infants whose mothers took Zoloft during pregnancy. These Zoloft birth defects run the gambit from minor problems to life-threatening problems that could lead to permanent injury or death.
Zoloft birth defects were filed. So far, every one has failed. This is the story.
An Overview of the Association Between Zoloft and Birth Defects
Over the last 10 years, SSRI’s like Zoloft have been accused by plaintiffs’ lawyers of causing everything from Akathisia to Zollinger-Ellison syndrome. I’m making up the latter, but you get the idea. Zoloft has been a controversial drug with a lawsuit target on its back. Some of these allegations have stuck, others have been thoroughly dismissed, and some we still just don’t know. The evidence of an association between Zoloft and birth defects, however, has been growing at an accelerated rate.
Zoloft (Sertraline) is one of the most prescribed drugs in the world for the treatment of various problems. It belongs to a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It is used to treat several conditions, including depression, obsessive-compulsive disorder (OCD), panic attacks, posttraumatic stress disorder (PTSD) social anxiety disorder, and premenstrual dysphoric disorder. Sertraline works by increasing the amounts of serotonin, a natural substance in the brain that helps maintain mental balance.
Back in July 2006, the FDA issued an alert after a study reported that infants born to mothers who took SSRIs after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants who were born to mothers who did not take antidepressants during their pregnancy. PPHN causes newborns to have increased pressure in the blood vessels in their lungs. As a result, they cannot get enough oxygen into their bloodstream. The risk of a woman having a child with PPHN in the general population is about 1 to 2 infants per 1000 live births.
While the FDA gathers other data about a potential association between SSRIs and neonatal PPHN, it has been recommended that health care providers carefully weigh the potential risks against the benefits of using SSRIs during pregnancy and discuss the pros and cons with their patients.
Zoloft is – and this is important – a Pregnancy Category C drug. This means that there are no adequate, well-controlled studies in pregnant women. Animal testing revealed that Zoloft given in the last third of gestation and throughout lactation resulted in an increase in stillbirths and deaths during the first 4 days after birth, and a decrease in body weights during the first four days after birth.
No one wants to see anyone suffer, but the reality is suffering to a child – who can’t speak up and communicate their feelings – is the worst. Zoloft’s ostensible effects on newborns have included complications requiring prolonged hospitalization, respiratory support, and tube feeding. Sometimes the problems arise at delivery. The list of problems includes respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. According to the Zoloft drug insert, these defects were probably due to either a direct toxic effect of the medication or a drug withdrawal syndrome.
Timing may play a part in what birth defects may show up in a newborn. The Mayo Clinic reports that there has also been an association between Zoloft and septal heart defects (a “hole in the heart”) and omphalocele (a defect in the wall of the abdomen) when Zoloft was taken earlier in the pregnancy. The list of possible birth defects is growing, to include various other defects such as cranial skull defects and spina bifida. Zoloft has also been linked to anal atresia (malformation of the anus) and limb reduction defects.
2024 Zoloft Birth Injury Lawsuit Update
A federal judge dismissed the lion’s share of the 300 birth injury lawsuits filed by children and their parents against Pfizer that alleged that Zoloft caused birth defects in children whose moms consumed the antidepressant during pregnancy. The judge did not say that Zoloft does not cause these injuries. Instead, she said that the science is just not there to make a viable claim yet.
In January 2023, the 1st Circuit Court of Appeals affirmed the trial judges rulings. So unless the Supreme Court agrees to hear a Zoloft lawsuit appeal. this litigation is effectively over.
Ultimately, the court looked at the current science. The judge considered all the scientific studies on Zoloft. The reality is that plaintiffs’ lawyers thought the evidence supported a causal association between Zoloft and birth defects. But the courts require more exacting proof.
Why Zoloft Birth Defect Lawsuits Failed
The plaintiffs’ lawyers needed to continue to build the case through medical evidence to prove that Zoloft causes these birth defects. That did not happen. And that is why this litigation has gone nowhere.
What Is the Latest from NIH?
The National Institute of Health has looked at this issue. What it says is a normal pregnancy has a 3-5% baseline risk of birth defects, known as the background risk.
Over 20,000 pregnancies involving Zoloft exposure have been documented. That is not a small number, obviously. Although some research indicates a possible heightened risk for heart or other birth defects, the NIH says that majority of studies do not show an increased risk of birth defects when the mom uses Zoloft.
But, I don’t think the NIH would disagree that an increased risk for certain specific birth defects, such as cardiac defects, cannot be completely ruled out. But it is hard to imagine the risk is great given how lukewarm the studies are.
How About the FDA?
The FDA has classified Zoloft as a Category C medication for use during pregnancy. This classification means that animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. The potential benefits may warrant the use of the drug in pregnant women despite potential risks.
I'm Pregnant. Is Zoloft Worth the Risk?
This is the ultimate question, right? Based on what we know, should you take Zoloft if you are pregnant? One thing is for sure – a lawyer should not be the one answering this question. This is truly an issue for you and your doctor.