Were You Prescribed Zofran® During Your First Trimester?
Zofran Risks, Side Effects, and Lawsuits
Were you prescribed Zofran® (ondansetron) to treat morning sickness? If your child was born with a birth defect like a cleft lip or palate, heart defect, or if you suffered a complication such as serotonin syndrome, you could be eligible for compensation.
Many doctors continue to prescribe the anti-nausea drug Zofran® for morning sickness, despite the fact that this is an off-label use not approved by the U.S. Food and Drug Administration (FDA). The risks associated with Zofran during pregnancy are serious and may be life-threatening to your baby.
Riddle & Brantley is prepared to answer any questions you may have and review your case with you. Contact our Zofran attorneys at (800) 525-7111 or fill out our free case evaluation form today.
What is Zofran?
Zofran is a drug manufactured by GlaxoSmithKline Inc. (“GSK”) The active ingredient in Zofran tablets and Zofran oral solution is ondanestron hydrochloride as the dehydrate, the racemic form of ondanestron and a selective blocking agent of the serotonin 5-HT3 receptor type.
What is Zofran approved for?
GSK lists 4 uses for Zofran on its self-produced Prescribing Information. These four uses below were also approved by the U.S. Food and Drug Administration.
- Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy including cisplatin ≥ 50 mg/m².
- Prevention of nausea and vomiting associated with initial and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
- Prevention of nausea and vomiting associated with radiotherapy in patients receiving total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
- Prevention of postoperative nausea and/or vomiting. As with other antiemtics, routine prophylaxis is not recommended for patient in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, Zofran tablets, Zofran orally disintegrating tablets, and Zofran oral solution are recommended even where the incident of postoperative nausea and/or vomiting is low.
The Problem with Zofran
The manufacturer, GlaxoSmithKline (GSK), encouraged OBGYNs and doctors to prescribe the drug to pregnant women. Also known by its generic name, Ondansetron, the drug was given to pregnant women in their first trimester of pregnancy to treat morning sickness (nausea and vomiting) associated with pregnancy. Although it was effective for treating nausea and vomiting, it came with a price. It has potential serious side effects to both mothers and infants. The drug has been on the market for approximately 20 years but was approved by the FDA (Food and Drug Administration) for treatment of nausea associated with cancer patients recovering from chemotherapy or post-surgical care. The FDA did not approve Zofran for use by pregnant women. As a result GSK recently paid severe fines to settle charges that it persuaded doctors to prescribe the drug to pregnant women.
50 % of all pregnant women suffer nausea or morning sickness during pregnancy…”
No one knows why pregnant women get nausea. Yet, 50 % of all pregnant women suffer nausea or morning sickness during pregnancy. This is a huge number of people to consider as potential users and the profits could be enormous for the manufacturer. The nausea and vomiting closely associated with pregnancy usually occurs during the first 3 months of pregnancy which is the infant’s most crucial developmental period. There have been numerous studies done in an effort to get more data on the drug. GSK has to admit that Zofran was not tested for use by pregnant mothers. However, this did not and does not stop GSK from promoting the off label use by pregnant women. Unfortunately, the FDA has not stopped Zofran or the generic form of the drug from being prescribed to pregnant women. However, the treating OBGYN or doctor now has a duty to warn all pregnant patients of the risks associated with this drug.
Zofran is not approved for morning sickness
Zofran was never approved by the U.S. Food and Drug Administration as a treatment of morning sickness but it was often prescribed “off label” to pregnant women. In fact, GSK even documented the following with respect to pregnant women taking Zofran:
GSK states the following in its Prescribing Information:
“Reproduction studies have been performed in pregnant rats and rabbits with daily oral doses up to 15 and 30 mg/kg/day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to ondanestron. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predicative of human response, this drug should be used during pregnancy only if clearly needed.”
In its Product Monograph, revised in December 2014:
“The safety of ondansetron for use in human pregnancy has not been established. Ondansetron is not teratogenic in animals. However, as animal studies are not always predictive of human response, the use of ondansetron in pregnancy is not recommended.”
Why was Zofran prescribed for morning sickness?
According to the Department of Justice, GSK agreed to plead guilty and to pay $3 Billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety dates, and its civil liability for the alleged false price reporting practices. This was the largest resolution in a health care fraud settlement in U.S. History.
In the settlement agreement, GSK agreed to resolve its civil liability for the following alleged conduct, among others: Promoting the drug Zofran for off-label, non-covered uses… The settlement further resolved allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.
Clearly, GSK saw huge profits in getting doctors to prescribe Zofran to pregnant women even though it wasn’t approved by the FDA. Millions of women get pregnant each year and a large percentage of them experience morning sickness and nausea during pregnancy.
What harm can Zofran cause in newborns?
Recent studies have suggested a causal connection between infants whose mothers were prescribed and took Zofran during the first trimester of the pregnancy. Many of those babies were born with the following devastating injuries:
- Cleft Palate: The roof of the mouth (palate) is formed between the sixth and ninth weeks of pregnancy. A cleft palate is when the tissue of the palate does not completely join together.
- Cleft Lip: The lip forms between the fourth and seventh weeks of pregnancy. A cleft lip occurs when the lip does not completely join before birth. This causes a visible opening in the upper lip. The size of the opening can vary significantly. It is not common for the opening to extend all the way to the nose. It is not uncommon for a baby to have both a cleft palate and a cleft lip.
- Heart Defects or Congenital Cardiac Malformations: These include heart murmurs and atrial septal defects also commonly known as a hole in the heart. An atrial septal defect is a hole in the wall between the two upper chambers of your heart. This may cause a shortened life span and surgery may be necessary to prevent any additional complications.
- Other Defects: Such as being born with only one kidney are also being researched. If you took Zofran and your child was born with any significant defect we encourage you to contact us and see if Zofran may have been the cause.
Risks Associated With Zofran
Recent studies suggest a causal connection between infants whose mothers were prescribed and took Zofran during the first trimester of the pregnancy.
Many of those babies were born with the following devastating injuries:
- Cleft palate
- Cleft lip
- Heart defect or congenital cardiac malformations (heart murmur and atrial septal defect or a “hole in the heart”)
- Other birth defects, such as born with only one kidney
In addition, mothers may be at risk of developing serotonin syndrome or irregular heartbeat, both of which may seriously jeopardize maternal safety.
If you or someone you know was prescribed Zofran for morning sickness during the first trimester of pregnancy and had a baby with a heart defect, cleft palate, cleft lip, or other birth defects after taking Zofran during the pregnancy, you may be entitled to compensation.
Zofran Not Approved By FDA During Pregnancy
The purpose of an FDA approval is to ensure that a drug can safely and effectively treat specific conditions. In many cases, doctors may prescribe medications for uses other than those that are deemed appropriate by the FDA. When this occurs, patients are left vulnerable to unforeseen side effects that could harm them.
Zofran did not receive approval for use by pregnant women….
While Zofran received approval to treat nausea and vomiting for chemotherapy, radiation therapy, and post-operative surgery, Zofran did not receive approval for use by pregnant women to treat morning sickness.
The FDA did not review Zofran’s safety for use by pregnant women suffering from nausea during pregnancy. Animal studies suggest that Zofran passes through the placenta to the baby, thus potentially increasing the likelihood of birth defects.
Information About Zofran Lawsuits
Yes. Lawsuits may be filed against manufacturer GlaxoSmithKline as a result of any harm allegedly caused by the drug. If you believe that the medical complications you or your child suffered happened because you took Zofran to treat morning sickness, our lawyers want to speak with you immediately.
In 2012, the U.S. Department of Justice charged GlaxoSmithKline with illegally marketing and selling Zofran for the treatment of morning sickness, and paying kickbacks to doctors who promoted the drug for such a purpose.
GlaxoSmithKline settled the case for $3 billion, but women and children continue to suffer from the company’s illegal tactics.
Contact Our Personal Injury Lawyers Today
At the law offices of Riddle & Brantley, our legal team is ready to get the details of your claim and help you determine whether you may be entitled to compensation.
We strongly believe that families who suffer from the complications of birth defects deserve to assert their legal rights, especially when the harm could have been prevented if the manufacturer had acted responsibly.
Our legal professionals offer complimentary evaluations to help determine the merits of your claim and work quickly to obtain fair compensation for your lawsuit. Speak to a Zofran attorney at our firm today about this dangerous drug. Fill out our free case evaluation form or call (800) 525-7111 to get started immediately. When justice counts, contact Riddle & Brantley.