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Some women with severe morning sickness were prescribed Zofran (ondansetron) and have had babies born with congenital malformations such as cleft palate and cleft lip, or various types of heart-related birth defects including:
Atrial Septal Defect / ASD (a hole in the atria of the heart)
Ventricular Septal Defect / VSD (a hole in the ventricle of the heart)
Tetralogy of Fallot / TOF (cardiac anomaly that refers to a combination of four related heart defects which commonly occur together; it affects normal blood flow through the heart)
However, Zofran is not approved by the FDA as treatment to reduce nausea when a woman is pregnant, especially during the first trimester. Rather, this GlaxoSmithKline drug was approved by FDA for the prevention of nausea or vomiting associated with chemotherapy and radiotherapy as well as in some instances following surgery.
As such, doctors have been precribing Zofran “off-label” for pregnant women — and sometimes there have been consequences to the baby.
Here are three reasons this situation is happening:
(1) Because women tend to experience morning sickness early in their pregnancy, a woman prescribed Zofran would likely be using this anti-nausea drug during the first trimester of the pregnancy — and this time period is when the fetus is most vulnerable to developing birth defects, congenital malformations, and other deformities;
(2) In a civil case filed by the US Department of Justice against GlaxoSmithKline, court documents alleged that Glaxo gave doctors kickbacks to prescribe Zofran for morning sickness — and, moreover, Glaxo provided false information about Zofran’s safety and effectiveness; and,
(3) Last but not least, GlaxoSmithKline essentially admitted it does not know if Zofran is safe for use by pregnant women when the drug company responded to a journalist’s question in this manner: “the safety of [Zofran (ondansetron)] for use in human pregnancy has not been established….”
For more about these critical facts you can read this investigative news report, “Birth defects blamed on unapproved morning sickness treatment”, which was published by the Toronto Star newspaper in June 2014.
As regards medical research about Zofran causing birth defects when used during pregnancy:
- One study found a two-times increased incident rate of children being born with major congenital heart defects if their mothers used Zofran in the first trimester of pregnancy.
- A second study indicated that Zofran use as a morning-sickness drug during pregnancy results in a more than doubling of the risk of there being a cleft palate for the child.
We are investigating possible drug injury lawsuits against GlaxoSmithKline for cases where Zofran used by pregnant women resulted in congenital heart defects and cleft palate as well as other birth defects, deformities, and malformations in children born to those women.
We encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible drug injury case. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, nor some other lawyer — about your case based on his many years of experience.
Some of the Zofran cases we are currently investigating:
Zofran – Tetralogy of Fallot (TOF) – 5 yr old child
Zofran – Cleft Lip and Heart Murmur – 1 yr old child
Zofran – Heart Defect causing Death – Infant
Zofran – Cleft Lip – 3 yr old child
Zofran – Ventricular Septal Defect; Heart Murmur – 10 yr old child
Zofran – Heart Murmur; Imperforate Anus; Kidney Problems – 3 yr old child
Zofran – Heart Defect; Hypospadias – Infant
Zofran – Cleft Palate; Hypospadias; Congenital Malformations – 3 yr old child
Zofran – Heart Murmur; Ventricular Septal Defect; Hypospadias – 1 yr child
Zofran – Atrial Septal Defect; Patent Foramen Ovale – 1 yr old child
In this December 2015 Medscape Pharmacists article, “[Zofran] Ondansetron in Pregnancy”, there is mixed evidence in the medical literature about what birth defects specifically and the extent of that danger.
In that article, Darren J. Hein, PharmD, summarizes the findings of several medical studies concerning Zofran-associated birth defects, a few of which you will see below.
For his review of “National Birth Defects Prevention Study. Medications used to treat nausea and vomiting of pregnancy and risk of selected birth defects” (Birth Defects Res A Clin Mol Teratol. 2012;94:22-30), Dr. Hein writes:
A larger, case/control study associated [Zofran (ondansetron)] with a significantly increased risk for cleft palate. The odds of cleft palate were 2.4 times higher with exposure to [Zofran (ondansetron)] during the first trimester (n = 55) vs unexposed pregnancies (n = 4479); however, the risk for cleft lip, hypospadias, or neural tube defects was similar in both groups. [footnote omitted]
A second study for which Dr. Hein presents his summary of the findings is “Ondansetron use in early pregnancy and the risk of congenital malformations—a register based nationwide cohort study” (Program and abstracts of the 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25-28, 2013; Montreal, Quebec, Canada. Abstract 25. Abstract 25, Pregnancy session 1):
Another group of Danish researchers, using the same Medical Birth Registry and National Patient Register, evaluated the teratogenic effects of [Zofran (ondansetron)] exposure during the first trimester using 1997-2010 data. Of the 897,018 births in this timeframe, prescription records suggested that 1248 women were exposed to ondansetron. The odds of fetal heart malformation were two times higher in infants of women exposed to [Zofran (ondansetron)] compared with unexposed women; the risk for major birth defects overall was similar. [footnote omitted]
And lastly, we get his take on “Use of ondansetron during pregnancy and congenital malformations in the infant” (Reprod Toxicol. 2014;50:134-137):
Swedish researchers used the Swedish Medical Birth Register and Swedish Register of Prescribed Drugs to gather data on pregnancies and exposure to [Zofran (ondansetron)] early in pregnancy. During the period between 1998 and 2012, 1349 women received [Zofran (ondansetron)] in early pregnancy. [Zofran (ondansetron)] exposure was not associated with an increased risk for severe birth defects; however, the odds of general heart defects were 1.6 times higher, and the odds of heart septum defects were 2.1 times higher. [footnote omitted]
As seen by these studies done by several different groups of international medical researchers, the fetal risks associated with the use of Zofran or ondansetron during the first trimester of pregnancy remain unclear.
Earlier Zofran articles by attorney Tom Lamb on the Side Effects Blog:
- Zofran MDL Pending In Massachusetts With Judge Dennis Saylor Presiding
- Federal Court Zofran MDL Motion; Generic Cases Filed In State Courts
- With Zofran – Birth Defects Lawsuits Filed, How Will GlaxoSmithKline Update Its Drug Label To Comply With New FDA Rule Effective June 2015
- A 2004 Medical Journal Article Indicated A Possible Link Between The “Morning Sickness” Drug Use Of Zofran And Hypospadias
- Zofran Associated With Birth Defects When Used During Pregnancy As An “Off-Label” Morning Sickness Treatment
All content by attorney Tom Lamb