An Increased Risk of Birth Defects and the Zofran Lawsuit

What is Zofran and Why is it Prescribed?

Zofran is a prescription drug that is intended to counteract feelings of nausea and vomiting by interacting with neurotransmitters in the digestive tract. This medication was approved by the U.S. Food and Drug Administration (FDA) to help cancer patients with nausea resulting from radiation and chemotherapy treatments. It has also been heavily promoted by the manufacturer, GlaxoSmithKline (GSK), as an effective method of managing morning sickness in pregnant women. However, this off-label use was never approved by the FDA.

The Zofran Lawsuit

There is a growing body of evidence that Zofran is linked to an increased risk of birth defects when pregnant mothers were prescribed the drug while they were carrying the child. The lawsuit alleges that the manufacturer, GSK, was aware of this increased risk, but failed to properly inform the Federal Government, healthcare providers, and pregnant patients who may potentially be prescribed the medication. The lawsuit further alleges that the manufacturer had full knowledge that the medication required additional testing and research trials before it should have been marketed for any other purposes. Because of this aggressive marketing, many healthcare providers recommended Zofran even though there were many other medications available with a much lower degree of risk involved.

Side Effects and Complications from Zofran

Zofran has been associated with a number of generally benign side effects such as headaches, dizziness, and constipation. There have been some reports of patients sustaining damage to the inner ear, but these accounts have not been confirmed. Zofran has also been linked to a potentially fatal form of irregular heartbeat called torsades de pointes.

The most serious side effect is the potential for the medication to increase the risk of birth defects in children whose mothers were prescribed the drug while pregnant.

The most serious side effect, and the reason for the number of recently filed lawsuits, is the potential for the medication to increase the risk of birth defects in children whose mothers were prescribed the drug while pregnant. While it is still early in the investigative process, the general consensus among doctors and other healthcare practitioners is that Zofran should not even be considered for use in pregnant women unless all other treatments have been ineffective and the patient’s morning sickness is so severe that drastic measures need to be taken.

Although roughly 80 percent of women suffer from some form of morning sickness, nausea, or vomiting while they are pregnant, there are other available treatments that are both safe and effective. Women who suffer from the most severe form of morning sickness, called hyperemesis gravidarum, will often require medication to safeguard against related malnutrition.

Patients who were prescribed Zofran and took the medication did so with the expressed intent to protect themselves and their babies from any complications associated with morning sickness. However, rather than protecting these patients and their children, Zofran has been linked to several different birth defects, including:

• Cleft lip
• Cleft palate
• Clubfoot
• Limb defect or abnormality
• Spina bifida
• Neural tube defects
• Anencephaly
• Kidney defects
• Skull deformities

Additionally, the most serious birth defects that have been connected to Zofran use in the first trimester of pregnancy are heart complications, including:

• Atrial septal defect (ASD)
• Other septal defects
• Tetralogy of Fallot
• Heart murmurs that are related to a structural defect
• Myocardial infarction (heart attack)

GSK and a History of Dangerous Drugs

The timeline of the lawsuit extends to before the first claim had been filed. Over the past decade, the manufacturer of Zofran, GSK, has faced multiple criminal charges and civil lawsuits related to various medications that they produce and market. The company has also frequently been questioned over seemingly unfair business practices.

If you have been injured by a defective drug, Speak with an Attorney

In 2012, GSK admitted guilt in a criminal trial for charges stemming from marketing the antidepressant drugs Paxil and Wellbutrin, along with Zofran, for uses that were not approved by the FDA. Additionally, they were charged with failure to report potential safety issues for patients who were taking the diabetes medication Avandia, which had been linked to such complications as congestive heart failure, liver toxicity, stroke, and hypotension. During this case, former employees and individuals with knowledge of the inside practices of the company brought to light information that implicated GSK in paying off physicians as an incentive to prescribe their products. The company was also found guilty of fraud concerning the Medicaid Drug Rebate Program. As a result, GSK paid over three billion dollars in total fines and restitution, making it the largest judgement against a pharmaceutical company in history.

Patients Who May Be Affected By the Zofran Lawsuit

Women who were prescribed Zofran (or a generic form of the drug) for morning sickness during their first trimester of pregnancy since 1996, and had a child that suffered from any of the related complications may have a claim against the manufacturers. It is important to remember that your healthcare practitioner was also a victim of GSK’s failure to properly inform all parties involved of the prospective dangers of the drug. If the company had not improperly marketed the medication as a safe treatment for pregnant women, many doctors would have recommended alternative treatments or therapies. Even if it has been years since your child was born, you may be entitled to make a claim in the Zofran lawsuit. Our legal team is constantly updating the current status of litigation.

Journal Articles Concerning Zofran Use By Pregnant Women 

• A December 2014 article in the American Journal of Obstetrics & Gynecology (AJOG) cites several studies that have looked at the use of Zofran to treat morning sickness in pregnant women. According to their findings, when patients were prescribed Zofran or the generic form of the drug during their first trimester of pregnancy, there was a two-fold increase in cardiac malformations and a 30 percent increase in congenital malformations. Additionally, the article cites a study by the Slone Epidemiology Center and the Centers for Disease Control and Prevention that found that women who had taken the medication were twice as likely to give birth to a child suffering from a cleft palate.
• An article in Canadian Family Physician published in October 2012 cited similar results for increased risks of certain birth defects as the AJOG article. The authors also discuss a September 2011 FDA warning about patients on Zofran suffering from electrolyte imbalance and congestive heart failure. Their conclusions state that this medication should not be used to treat morning sickness in pregnant women unless all other possibilities have proven unsuccessful.

Contact an Experienced Pharmaceutical Attorney

If you were prescribed Zofran while in the first trimester of your pregnancy and had a child that suffered from any of the complications that have been linked to the medication, please contact a member of our experienced team. We will provide a complimentary case evaluation and help guide you through the legal process.