Plenty of women experiencing severe bouts of nausea and vomiting may turn to anti-nausea medications like Zofran to relieve their symptoms. However, recent studies have shown that the popular anti-nausea drug Zofran, which is commonly promoted off-label by GlaxoSmithKline as a treatment for morning sickness in pregnant women, may actually be linked to an increased risk of severe birth defects in babies exposed to the medication in utero. If you believe your child has been adversely affected by an alleged Zofran birth defect, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by potentially dangerous medications, and can help put you in touch with a reputable Zofran lawyer who has experience handling birth defect claims.
The management of nausea and vomiting during pregnancy depends on the severity of the symptoms, but some possible alternative treatments include:
Zofran (ondansetron) is a 5-HT3 receptor antagonist medication manufactured by pharmaceutical giant GlaxoSmithKline and used to treat nausea and vomiting in chemotherapy and surgery patients. The drug was approved by the FDA in 1991, and functions primarily by acting on the nervous system, blocking serotonin and increasing gastric emptying, which helps relieve nausea and vomiting. Zofran is not FDA-approved for use in pregnancy, but many doctors prescribe the anti-nausea drug off-label to pregnant women suffering from hyperemesis gravidarum, a severe form of morning sickness often described as unrelenting, excessive pregnancy-related nausea and/or vomiting requiring hospitalization and resulting in severe dehydration, muscle wasting, nutritional deficiencies and significant weight loss – all of which pose serious health risks to both the mother and the fetus. This is especially problematic in light of recent research, which has established a potential connection between the use of Zofran during pregnancy and an increased risk of heart defects, cleft lip, cleft palate and other devastating birth defects among babies exposed to the drug in utero. These side effects have forced many parents to discuss Zofran birth defect lawsuits with attorneys.
Despite the fact that Zofran has been on the market in the United States for more than 20 years, it was only recently that studies began to examine the possible risk of birth defects as zofran side effects among babies exposed to the morning sickness drug during pregnancy. Among the birth defects possibly linked to Zofran use in pregnant women are:
Zofran has not been approved for use in pregnant women, and the FDA has categorized Zofran as a pregnancy Category B medication, which means there is no adequate or well-controlled research examining the safety of Zofran use in pregnant women. This is due to the fact that fetal safety data regarding Zofran is based on less than 200 births, although a growing body of research has demonstrated the potential adverse side effects Zofran can have on a developing fetus. Pregnant women with questions about the safety of Zofran should talk to their doctors about potential Zofran side effects if they are using the drug and the doctor prescribes it to them for nausea.
In a study published in January 2012, based on data from approximately 9,000 pregnant women who participated in the National Birth Defects Prevention Study, researchers found a 2.4-fold increased risk of cleft palate among babies whose mothers took Zofran while pregnant. Six months after these findings were published, the U.S. Department of Justice ordered GlaxoSmithKline to pay $3 million to resolve claims that the drug company marketed many of its products for off-label uses not approved by the FDA, including the use of Zofran in pregnant women experiencing morning sickness. The zofran side effects are devastating for both the babies with birth defects and their families. The DOJ also accused GSK at that time of illegally paying kickbacks to doctors who prescribed Zofran to patients. Because of these factors, Zofran birth defect lawsuits are being investigated by lawyers.
In February 2013, the New England Journal of Medicine published a study indicating that Zofran did not increase the risk of birth defects in babies. However, half of the women involved in the study took Zofran after the 10th week of pregnancy, at which point babies have a lower risk of suffering birth defects like heart malformations, cleft lip and cleft palate. Research has shown that unborn babies face the highest risk of birth defects during the first trimester, a time when many women aren’t even aware they are pregnant. Six months after the NEJM study was published, another team of researchers analyzed the same pregnancy data and found that Zofran increased a baby’s risk of birth defects by 30%, and doubled their risk of heart defects. Heart defects and oral clefts (cleft lip & cleft palate) are the two main Zofran side effects being pursued by attorneys in the new wave of Zofran birth defect lawsuits.
According to a 2014 report by the Toronto Star, heart malformations and other birth defects have been linked to the use of Zofran during pregnancy for morning sickness. Some of the most severe outcomes of Zofran treatment among pregnant women include: two fetal deaths; one baby born with a musculoskeletal abnormality; multiple reports of kidney defects and heart malformations; a suspected mouth deformity; heart murmur; jaundice; two heart defects, including an atrial septal defect; and fetal growth restriction in six infants, including four babies who weighed as little as 4.5 pounds at birth.
The FDA has not issued specific warnings about the use of Zofran in pregnancy, despite the growing body of research linking the anti-nausea drug to an increased risk of serious birth defects, which could pose a serious problem for women with electrolyte imbalances due to severe morning sickness, or hyperemesis gravidarum. The following are the actions the FDA has taken to warn consumers and the medical community about the risk of Zofran side effects:
September 2004 – A study published by the medical journal BJOG: an International Journal of Obstetrics and Gynaecology found case reports tying Zofran to a risk of hypospadias birth defects, but this alleged risk was never investigated by GSK. Hypospadias is a serious birth malformation in boys characterized by a urethral opening that is located somewhere other than at the tip of the penis. The condition almost always requires surgery, and without treatment, boys born with hypospadias may be forced to urinate sitting down, and may suffer from sexual dysfunction later in life.
November 2011 – A study published by Birth Defects Research found that the use of Zofran in pregnancy to treat nausea and vomiting associated with morning sickness, was associated with a 2.4-fold increased risk of cleft palate birth defects in babies.
January 2012 – In a study based on data from approximately 9,000 pregnant women who participated in the National Birth Defects Prevention Study, researchers found a 2.4-fold increased risk of cleft palate among babies whose mothers took Zofran while pregnant.
February 2013 – The New England Journal of Medicine published a study indicating that Zofran did not increase the risk of birth defects in babies. However, half of the women involved in the study took Zofran after the 10th week of pregnancy, at which point babies have a lower risk of suffering birth defects like heart malformations, cleft lip and cleft palate. Research has shown that unborn babies face the highest risk of birth defects during the first trimester, a time when many women aren’t even aware they are pregnant, and a number of other studies have disputed these NEJM results.
August 2013 – Six months after the NEJM study was published, another team of researchers conducted another study analyzing the same pregnancy data, and found that Zofran increased a baby’s risk of birth defects by 30%, and doubled their risk of heart defects.
December 2014 – One study published in the journal Reproductive Toxicology found that use of Zofran during the first trimester of pregnancy doubled the risk of “hole in the heart” birth defects like atrial septal defects and ventricular septal defects. Overall, the risk of heart defects among babies exposed to Zofran in pregnancy was 62% higher than normal.
December 2014 – An investigation by the Toronto Star indicated that Zofran has been linked to a number of instances of birth defects in babies, including: two fetal deaths, multiple reports of kidney malformations, intrauterine growth restriction in six infants, musculoskeletal abnormalities, and one baby’s mouth deformity, heart murmur, jaundice and two heart defects.
March 2015 – A study published in Pediatric Emergency Care highlights two instances where children died from heart problems after being given ondansetron, the active ingredient in Zofran.
According to court documents, GlaxoSmithKline knew as early as 1992 that Zofran was capable of passing through the human placenta and presenting an “unreasonable risk of harm” to developing babies in the womb. Despite this knowledge, GlaxoSmithKline continued to promote the drug as a treatment for morning sickness in pregnant women, and Zofran lawsuits brought against the drug maker allege the following:
The potential for Zofran to cause birth defects in unborn babies is particularly alarming because women of childbearing age may take the controversial drug to combat nausea or vomiting without realizing they are pregnant and may be exposing their unborn baby to serious harm. If you took Zofran while pregnant, and your child has been diagnosed with a severe birth defect like cleft lip, cleft palate, fetal growth restriction or a heart malformation, contact a knowledgeable Zofran attorney today for legal help. You may have grounds to file a Zofran lawsuit against GlaxoSmithKline, in order to pursue financial compensation for your child’s birth defects, pain and suffering, and current and future medical expenses.