When FDA-Approved Antidepressants Cause Birth Defects


Most FDA-approved drugs go through rigorous safety testing, but pregnant women are usually the exception. Because developing fetuses are incredibly vulnerable, most pregnant women are not eligible for clinical trials. As a result, many otherwise-safe medications can cause babies to develop birth defects. Two such drugs include anti-nausea medication Zofran, and certain antidepressants called SSRIs. For this reason, birth defect lawsuits for both drugs are now underway.

Antidepressants and Birth Defects

Depression can be dangerous for babies in utero. That said, doctors recently discovered possibly even more harmful: antidepressants called selective serotonin reuptake inhibitors (SSRIs). Many women take SSRIs before or during pregnancy to combat depression. Unfortunately, SSRI use can cause birth defects and other childbirth complications.

Antidepressants named in pending lawsuits include Celexa, Prozac, Zoloft and Paxil. They work by raising serotonin levels higher than normal. This drug can harm a developing fetus once it crosses the placental barrier. Potential defects and complications include pulmonary hypertension, cleft palate, autism, congenital heart defects, low birth weight and more.

It’s important to note that while taking SSRIs before or during a pregnancy can be dangerous for your baby, you should not stop taking antidepressants unsupervised. Instead, speak with your doctor about your other options.

Zofran and Birth Defects

Zofran’s FDA approval only covers specific indications. Developed to treat chemotherapy and post-operative nausea, Zofran has been effective in instances of uncontrollable vomiting. Though not tested on pregnant women, many doctors began prescribing the drug to women experiencing debilitating morning sickness. While Zofran doesn’t harm mothers, it can cause serious complications in developing fetuses. Numerous birth defects have occurred as a result of taking the drug, but cardiac problems, such as holes in the heart, have been particularly prevalent.

GlaxoSmithKline faces serious scrutiny for illegal marketing and failure to report safety data. Zofran’s only FDA-approved use is for post-operative treatment, not pregnancy. But salespeople promoted Zofran to doctors for morning sickness relief. GlaxoSmithKline settled for off-label marketing in 2012, but Zofran birth defects and Zofran lawsuits have not subsided as more women realize what the drug did during their pregnancies.

One North Dakota woman recently filed a claim against the manufacturer after her daughter got sick and needed an X-ray of her heart. Upon finding that her heart was smaller than normal and filled with several extra holes, the mother realized that something had gone terribly wrong during her pregnancy. Her doctor prescribed Zofran for morning sickness, but didn’t warn her about potential birth defect risks.

A Recurring Birth Defect: Holes in the Heart

One interesting similarity in both Zofran and SSRI birth defects is the prevalence of holes in the heart, a condition that can cause lifelong circulation problems including strokes. While some parents find out about these defects early on in a child’s life, holes in the heart sometimes do not become apparent until age 18 or later. Many companies like GlaxoSmithKline made settlements years ago, but are still faced with major birth defects lawsuits today.

It’s clear that both Zofran and SSRIs are dangerous to a developing fetus, but we still don’t know how many other drugs may join this category in the near future. Due to the limited ability to test the safety of drugs on pregnant women, many drugs are prescribed to them without knowledge of how they would affect a developing baby.

Unfortunately, research indicates that it isn’t just drugs taken during a pregnancy that can affect a fetus – drugs taken in the months before a pregnancy can have lasting detrimental effects as well.

What You Can Do

If you or someone you know took Zofran or SSRIs during pregnancy, you may be eligible for compensation. It’s a good idea to speak with an attorney who has experience with mass torts of this nature, as they can review your case and help you take the necessary steps to be successful moving forward. Many women have won significant damages after their children developed defects while they were pregnant.

1. McLean, Jesse. “Birth Defects Blamed on Unapproved Morning Sickness Treatment.” The Toronto Star.

2. “Antidepressants: Safe During Pregnancy?,” Mayo Clinic (2015)

3. Boehm, Krista. “Dilworth Mother Says Prescribed Medication for Nausea Caused Daughter’s Heart Defect.” Valley News Live.

Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as, Yahoo!, MSN, AOL, Xfinity,, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.