According to new research from Sweden, the anti-nausea medication Zofran may carry some pregnancy side effects, including allegedly increasing the risk of heart birth defects.

The Reproductive Toxicity medical journal published a Zofran study last year, which suggested a strong correlation between the use of this GlaxoSmithKline anti-nausea medication and an increased risk of women giving birth to children with birth defects that damage the heart.

The Zofran study used data provided by the Swedish Medical Birth Register and from the Swedish Register of Prescribed Drugs, which allowed researchers to identify 1,349 babies born between 1998 and 2012 whose mothers took Zofran during the pregnancy.

According to the Zofran heart defects study, the Swedish researchers found evidence that demonstrates a strong association between increased risk heart malformation birth defects and Zofran use during pregnancy. The Swedish Zofran study found a notable occurrence of septum defects allegedly caused by the anti-nausea drug.

The researchers did warn that an overall risk of major malformations and birth defects was not found to be correlated with Zofran. However, the Zofran heart defect study did find a specific Zofran risk of cardiovascular birth defects. According to the Zofran study, women who used Zofran while pregnant were up to 62 percent more likely to give birth to children with heart defects. Additionally, fetuses who were exposed to Zofran were two times as likely to develop septum defects, including ventricular septal defects (VSD) and atrial septal defects (ASD).

The Zofran heart defects research study states,“[I]f an association between the use of ondansetron and an increased risk for cardiovascular defects is true, the strongly increasing off label use of the drug at nausea and vomiting in early pregnancy must be regarded as unsuitable and should be avoided.” The Swedish researchers concluded that women suffering from morning sickness or hyperemesis gravidarum (HG) should not use Zofran, at least until further Zofran heart defects studies are performed.

Zofran Pregnancy Research Studies

A number of Zofran birth defects studies have been conducted in different countries, studying the potential side effects of taking Zofran while pregnant. According to a 2013 Zofran pregnancy study conducted in Denmark, a total of 900,000 births were reviewed in order to study the prevalence of Zofran birth defects among pregnant Danish mothers. This Zofran birth defects study allegedly found a 30 percent increased risk of overall birth defects when the mother took Zofran during her pregnancy. This Danish study also noted a doubled risk of Zofran heart defects based on the Denmark birth data.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Some potential Zofran birth defects reported in various Zofran studies include:

• Cleft lip
• Cleft palate
• Heart defects
• Kidney defects
• Musculoskeletal defects
• Decreased  fetal growth
• Fetal death

Those affected may choose to pursue a Zofran birth defects lawsuit or join a Zofran birth defects class action lawsuit to gain compensation for the pain and suffering experienced by their children and the financial hardships of treating and managing their babies’ alleged Zofran birth defects.