Zofran® During Pregnancy Malpractices
Although Zofran® is not yet tested or approved for pregnant women, it is often prescribed for nausea and morning sickness. Unfortunately, avoiding morning sickness can come at a great cost. Severe morning sickness can cause uncomfortable and painful pregnancy. When a doctor prescribes medicine to alleviate the condition, you have trust that it won’t cause harm to your unborn child.
If you were given Zofran® in the course of your perinatal period and your child was born with congenital disabilities, you should contact anIdaho Medical Malpractice Lawyer. Our experienced team at Lister Frost will fight tirelessly on your behalf to ensure you get the justice and compensation you deserve.
What is Zofran®?
Zofran® (ondansetron) was invented in the 1980s in England and patented by drug manufacturer GlaxoSmithKline in the United States. The Food and Drug Administration approved Zofran® in 1998 to treat nausea and vomiting in chemotherapy and surgery patients. Zofran® was NOT approved for use by pregnant women for morning sickness. In 2012 GlaxoSmithKline settled claims brought by the United States government for marketing drugs, including Zofran®, for “off-label” or “unapproved” uses.
Is Zofran® Safe For Pregnant Mothers?
The Food and Drug Administration (FDA) warns against the use of Zofran® during pregnancy. Initially, in 1991, the FDA had approved Zofran® to treat nausea and vomiting resulting from cancer chemotherapy or surgery. At no point has the medication ever been submitted to the FDA for pregnant women to control morning sickness.
The FDA categorized Zofran® as Pregnancy Category B, meaning it is yet to be tested for safety. No studies were carried out to prove it is safe for pregnant women, categorizing its use during pregnancy as “off-label”. No Zofran dosage has been proven to be safe for pregnancy.
How Does Zofran® Cause Birth Defects?
Zofran® functions by blocking the chemical actions in the body that trigger vomiting and nausea. Unfortunately, women are most likely to experience morning sickness during organogenesis. As the early stage of organogenesis involves the formation of vital organs, it is a very delicate and important process.
The interference with Zofran® chemicals in the body during this period is what causes interruptions in developing embryos. This inhibits or alters organ development resulting in congenital disabilities.
Can Zofran® cause birth defects?
- A 2013 medical journal report from TDM Journal Club cautioned against ondansetron (Zofran®) for the treatment of morning sickness. Researchers cited safety concerns for both the mother and the unborn child. In comparing studies from Denmark, researchers noted:
- A two-fold increased risk of heart defects. Cardiac malformation incidents doubled when ondansetron was used in the first trimester of pregnancy.
- Risks to mothers included abnormal heart rhythms and electrolyte imbalance, and life-threatening drug interactions between ondansetron (Zofran®) and anti-depressant medications.
Birth Defects Associated With Zofran®
Heart defects: A heart defect can have severe repercussions for babies. Zofran® is thought to cause an increased risk of ventricular septal defects. This is a disorder that causes a hole in the heart wall — which, if not repaired, may cause serious complications such as the potential for life loss. Zofran® might also be linked with other heart defects, including;
- Atrial septal defects
- Transposition of arteries
- Heart murmurs
Cleft palate: A palate is the higher part of the mouth that is usually developed between weeks 6-9 of gestation. When the tissue that makes up the mouth structure doesn’t develop properly, it won’t intersect together. Children might have both the front and back palate leaving the opening whereas others might only have a small part open. Cleft palate surgery is done during early childhood, with further procedures required as they grow.
Cleft lip: This condition occurs when the tissues developing the lip lack to join completely before delivery. The lip opening might be minor or more prominent, with the opening displaying at the lip area and spreading into the nose.
Other severe birth defects: Additional evidence available on Zofran® associated congenital disabilities include:
- Club foot
- Kidney failure
- Organ malposition or malformation
- Skull malformation
Other studies have raised concerns about ondansetron (Zofran®)
- More than double the risk of cleft palate. A January 2012 study of more than 9,000 women by the Sloan Epidemiology Center and the Centers for Disease Control and Prevention detected twice the risk for cleft palate associated with ondansetron (Zofran®) use in the first trimester of pregnancy.
- A 2006 study of 41 women in their first trimester was given ondansetron (Zofran®). The drug was present in every fetal tissue sample, indicating that Zofran® crosses the human placenta during pregnancy.
- Twenty Canadian women who took Zofran® during 2012 reported birth defects and two infant deaths to the U.S. Food and Drug Administration. In June 2014 the Canada Toronto Star reported that some doctors suspected a link between (Zofran®) and heart, mouth, and musculoskeletal abnormalities. Musculoskeletal abnormalities include club foot, joint, limb, facial, and vertebral malformation.
In July 2012 Zofran® manufacturer GlaxoSmithKline (GSK), while denying any wrongdoing, settled what the United States Department of Justice called the “largest health care fraud settlement in U. S. history.”
Without admitting liability, GlaxoSmithKline paid $3 billion ($3,000,000,000) to settle certain criminal and civil actions brought by the United States. A Settlement Agreement between the United States et al. and GlaxoSmithKline dated June 28, 2012 stated that GSK expressly denied the allegations.
In the Settlement Agreement, the United States continued to maintain that its allegations were “well-founded.” The United States alleged that GlaxoSmithKline had “knowingly” promoted Zofran® for non-approved (“off-label”) use, including pregnancy-related nausea. The United States also claimed that federal health care programs were billed for fraudulent purchases of Zofran®.
While denying the allegations, under the Settlement Agreement GlaxoSmithKline paid more than $54 million to resolve charges that GlaxoSmithKline had violated a Federal Anti-Kickback Statute by paying healthcare professionals to prescribe Zofran® and other medications.
The Agreement listed:
If You Took Zofran® And Your Baby Had A Birth Abnormality
Please contact us now at [phone_number] For A Free, Confidential Consultation.
You are not alone.
Mothers who took this drug did not know that Zofran® had not been tested for use during pregnancy. You and your child may be legally entitled to compensation for pain and suffering, medical costs, loss of income, emotional distress and other damages.
Call Litster Frost Injury Lawyers at (208) 333-3333. Our legal team has successfully litigated medical and product liability cases nationwide.
If you took Zofran® during pregnancy and later learned of a birth abnormality, please tell us your story and let us help you.
Call us now at (208) 333-3333, click the chat button to the right or submit the form below for a free, no-obligation confidential consultation.
* Individual cases are evaluated and compensated on their own merits.
Contact Idaho Medical Malpractice Lawyer
If you were given Zofran® for vomiting and queasiness during the perinatal period and your child got serious birth issues, our Idaho Medical Malpractice Lawyer will help you. If your child has been negatively affected by prescription medicine, our experienced attorneys will work with you to file a medical malpractice lawsuit and ensure you get the compensation you deserve.