Zofran Birth Defects: Craniofacial Conditions Linked to Nausea Drug

craniofacial conditions

Lawsuits are mounting as women report Zofran birth defects associated with popular nausea drug. Many women take Zofran during pregnancy to mitigate the effects of severe morning sickness. Recent research indicates that Zofran crosses the placental barrier and causes a variety of birth defects – including craniofacial conditions. Many claims indicate these defects are a result of illegal marketing on the part of drug maker GlaxoSmithKline. Notably, these craniofacial conditions and other birth defects could have been prevented with adequate prescribing information.

Zofran Birth Defects Linked to Craniofacial Conditions

Craniofacial defects are defined as an abnormality of the head or face, which can be physically and psychologically debilitating for a growing child. They encompass a variety of specific defects, some of which Zofran has been closely associated with. Craniofacial defects include:

  • Craniosynostosis (when the bones in a baby’s skull fuse together too early)
  • Microtia (when the external part of the ear doesn’t form properly)
  • Anotia (when the external part of the ear is missing)
  • Orofacial clefts (when the lips and mouth don’t form properly)

Simply put, these defects affect both the structure and function of a child’s face and head. These craniofacial conditions can cause crucial and oftentimes permanent developmental problems. While this makes day-to-day life difficult for the child, it also raises their average medical costs significantly. Many of these conditions, such as cleft palates, require multiple surgeries, which may not fully rectify the problem. Others are irreparable, which can be devastating for the family.

The Centers for Disease Control and Prevention says that identifying certain medicines women take during pregnancy as a potential step for preventing such craniofacial conditions.

Congenital Defects Other Than Craniofacial Conditions

Other Zofran birth defects include congenital defects (e.g., holes in the heart) which are particularly problematic. Because they’re internal defects, they frequently don’t reveal themselves until the child’s much older. Some children with these defects don’t find out until their late teens, when congenital defects can cause serious problems (like strokes). Due to the nature of medications during pregnancy, it’s unclear how many other Zofran birth defects may exist.

Unfortunately, many drugs taken during pregnancy cross the placental barrier, though not all are detrimental. An interesting phenomenon occurs due to the differing pH between the fetus and surrounding fluid. In fact, many drugs get “trapped” inside the baby’s body after crossing through the placenta, which may further aggravate developmental defects.

Drugs and Their Indications: An Important Lesson in Clinical Trials

While Zofran birth defect lawsuits address the lack of general warning, Zofran was never approved for treating morning sickness. Originally intended for post-operative and chemotherapy-induced nausea, Zofran went through a series of clinical trials on that didn’t include pregnant women. While it’s technically safe for use in non-pregnant women, GlaxoSmithKline failed to run clinical trials during pregnancy. That’s because it’s simply too risky for developing babies.

The push to prescribe Zofran during pregnancy allegedly came as a result of the drug’s marketing. Some women experience a sever form of morning sickness called hyperemeses gravidarum. This nausea is so debilitating that victims cannot keep anything down. Due to Zofran’s efficacy against nausea, doctors prescribed it to pregnant women while unaware of any birth defect risks. Most plaintiffs claim that had they known of the drug’s associated risks, they would not have taken it.

In the wake of these findings, most physicians stopped prescribing Zofran during pregnancy in favor of alternatives. For women taking Zofran now or during a previous pregnancy, however, the damage is already done.

Speak With Someone Who Can Help

If you or someone you know took Zofran before or during a pregnancy and have a baby with craniofacial conditions or other birth defects, you may have an eligible claim. Before you begin, it’s a good idea to speak with an attorney who’s familiar with mass torts of this nature. As Zofran lawsuits continue to mount, there has never been a better time to make your claim. Get your free Zofran case review today to see if you may be entitled to financial compensation.

1. “July: National Cleft and Craniofacial Awareness and Prevention Month.” Centers for Disease Control and Prevention. November 21, 2014. Accessed April 21, 2015.

2. McLean, Jesse. “Birth Defects Blamed on Unapproved Morning Sickness Treatment.” The Toronto Star. Accessed April 21, 2015.

3. “Placental Transfer of Ondansetron during Early Human Pregnancy.” National Center for Biotechnology Information. Accessed April 21, 2015.

Jared Heath

Jared Heath is the author of The Sound in the Silence. In his role as an SEO content and digital marketing strategist, Jared was directly responsible for managing DrugJustice.com's editorial calendar and published articles on this website from 2015 to 2016. He is now pursuing a new career as a chiropractor.