Morning sickness is a problem that afflicts around 80% of all pregnant women. That’s why an estimated one out of four pregnant women take Zofran to treat symptoms that can leave women feeling nauseous and limited. The only problem with Zofran becoming the most-prescribed drug to treat morning sickness is that the drug has not been approved by the U.S. Food and Drug Administration for use by pregnant women.
Zofran drugmaker GlaxoSmithKline has illegally marketed the drug for morning sickness despite knowing of the dangers it could pose to unborn children. Studies have linked Zofran to severe side effects, including birth defects, heart defects, cleft palate, and more.
Hundreds of women have turned to the legal system to get justice and restitution for unexpected side effects that have changed lives forever.
What is Zofran?
Zofran is the brand name of a now generic drug called ondansetron. It belongs to a class of drugs called serotonin 5-HT3 receptor antagonist. It is also called an antiemetic because it combats vomiting and nausea.
The drug is designed to prevent the feeling of nausea and vomiting caused by cancer treatment like chemotherapy, radiation therapy, and surgery.
Zofran Dosage Information
Zofran comes in two variations: standard tablets and orally disintegrating tablets. It also came in a now discontinued oral solution. In some cases, it can be injected intravenously. Both tablets come in 4 mg and 8 mg dosages.
The first dose of Zofran is usually administered 30 minutes before the start of chemotherapy, one to two hours before radiotherapy, and an hour before surgery. Dosage depends on the type of Zofran prescribed and the condition being treated.
The following are the recommended dosages1 for adults.
For adults undergoing cancer chemotherapy that causes high amounts of nausea, a single 24-mg dose is recommended. Those undergoing cancer chemotherapy that causes moderate amounts of nausea, a single dose of 8 mg is given before the start of treatment with another 8 mg dose eight hours after the first. Another 8 mg dose is given every 12 hours in the day or two after treatment.
For radiotherapy, the dosage also differs. If the patient is undergoing total body irradiation, an 8 mg dosage is given up to two hours before each fraction of radiotherapy each day. For other radiotherapy treatments, an initial 8 mg is given with 8-mg doses every eight hours after.
In surgery, a dose of 16 mg is given an hour before anesthesia.
Although it has not been approved for morning sickness, Zofran will also be prescribed to some pregnant women. Dosages given by doctors vary between 4 mg to 8 mg every eight hours or as needed.
How Zofran Works
As a serotonin 5-HT3 receptor antagonist, Zofran helps prevent nausea and vomiting by blocking a chemical called serotonin. As a neurotransmitter, serotonin plays an important role in regulating moods and is believed to affect autonomic functions, such as nausea and vomiting.
Serotonin is often created when there appears to be a dangerous substance attacking the body. It triggers a natural response, such as vomiting or diarrhea, to eliminate the danger. By inhibiting the serotonin receptors, Zofran can prevent those uncomfortable responses from getting to the brain.
Approved Uses for Zofran
Although Zofran is most commonly administered to pregnant women, it has only been approved by the FDA for select uses.
Zofran is approved for the prevention of nausea and vomiting caused by cancer treatments like chemotherapy and radiotherapy. It is also approved to prevent nausea and vomiting in postoperative patients.
Drugmaker GlaxoSmithKline has never pursued official approval for morning sickness.
Common Zofran Side Effects
Like all prescription drugs, Zofran is associated with some side effects.
Common Side Effects
Here are some of the most common side effects seen in adults and children:
- Shortness of breath
Serious Zofran Side Effects
A number of serious side effects have also been reported in patients taking Zofran. These include adverse reactions in pregnant women taking Zofran:
- Birth defects
- Serotonin Syndrome
- Acute liver failure
- Allergic reactions
- QT Interval Prolongation
- Chest pain
Brief History of Zofran
Throughout the mid-1980s, ondansetron was developed by GlaxoSmithKline in the United Kingdom. In 1991, the Zofran injection was the first 5-HT3 receptor antagonist to hit the market when the FDA approved it for the treatment of nausea among cancer patients undergoing chemotherapy. The following year, the FDA approved the Zofran tablets.
In 1995, a Zofran injection mix was approved by the FDA. The premixed injection was pulled off the market in 2012 because of the potential for serious cardiac risks.2
The Oral Solution of Zofran was approved in 1997 but was later discontinued in 2016. The reasons for discontinuation were not made clear.
Finally, the Zofran Orally Disintegrating Tablets were approved3 in 1999.
In 2001, sales of Zofran in the United States reached $859 million. Just a year later, the numbers topped $1.1 billion. The drug continued to be a huge moneymaker for GlaxoSmithKline until 2006 when the pharmaceutical company lost the patent on ondansetron. By December of that year, the first generic versions of ondansetron were approved by the FDA.
The rise of ondansetron generics likely helped increase the widespread use of the drug to treat nausea and vomiting, even in pregnant women.
Zofran Marketed For Off-Label Morning Sickness Use
Although Zofran was not prescribed until the 1990s, an important event happened in 1983 that would later help propel Zofran to its blockbuster status. In 1983, the only FDA-approved drug to treat morning sickness in pregnant women called Bendectin was voluntarily removed from the market.
Bendectin was sold to more than 33 million pregnant women4 in the world; however, mounting lawsuits that claimed Bendectin caused birth defects led drugmaker Merrell Dow Pharmaceuticals to pull the medication from the market.
The same year Bendectin was withdrawn from the market, there was a drastic 50% increase5 in pregnant women being hospitalized for excessive vomiting.
With Bendectin off the market, doctors looked for alternatives to treat morning sickness. Many turned to Zofran. However, evidence suggests that the doctors often didn’t come to the conclusion on their own.
GlaxoSmithKline Agrees to $3 Billion Settlement
As early as 2001, those within GlaxoSmithKline saw the hole in the market waiting to be exploited. In response, two separate divisions within the company teamed up to cross-promote both the antacid Tums and Zofran to pregnant women.
Although marketing a drug like Zofran for a use that has not been approved by the FDA is illegal, GlaxoSmithKline continued to push the drug to obstetricians and gynecologists. As a result, the number of prescriptions for morning sickness rose dramatically.
This information came from whistleblowers within GlaxoSmithKline and ultimately led to legal action by the U.S. Department of Justice. As a result, GlaxoSmithKline pled guilty to allegations of fraud and failure to report safety data. It agreed to pay a record $3 billion in 2012.
The settlement became the largest healthcare fraud settlement in U.S. history and dealt with various GlaxoSmithKline drugs, including Paxil, Wellbutrin, and Zofran.
“[The settlement] further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women,” the Justice Department announced6 at the time It also includes allegations that GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex.”
Studies Link Zofran to Birth Defects
Despite the massive settlement with the Department of Justice, the safety of the drug was never brought up. Instead, scientists have relied on studies and post-marketing analyses to find out whether Zofran has hidden side effects in pregnant women taking the drug.
Research has been mixed about whether Zofran causes birth defects. In a 2012 study7 called “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects,” researchers found treating morning sickness with Zofran increased the risk of babies developing a cleft palate by 237%. Then, in 2014, a study8 of more than a thousand infants born to women taking Zofran in Sweden found a statistically significant increase in heart defects in children.
However, a 2016 study9 found no evidence linking Zofran with an increase in birth defects.
Users File Hundreds of Zofran Lawsuits
Although the FDA has yet to warn of possible risks of birth defects or malformations in babies whose mothers took Zofran during pregnancy, it has warned that Zofran is associated with an increased risk of serotonin syndrome10 and potentially fatal abnormal heart rhythm.11
However, pregnant women who have taken Zofran have reported birth defects in their babies. This has led to hundreds of lawsuits against GlaxoSmithKline.
In February 2015, a mother in Minnesota filed the first Zofran lawsuit12 over allegations that the drug caused her two daughters to develop heart defects in utero. Plaintiff Cheri Flynn claims her daughter was born with a congenital heart defect in 2004 after she took Zofran in her first trimester for morning sickness. Her second daughter was born in 2006, also with a heart defect. Flynn says she was not warned of the risks that GlaxoSmithKline hid from the public.
Not long after Flynn filed the first lawsuit, others immediately followed. In 2015, Leslie and Pam Marlenee filed a lawsuit13 against GlaxoSmithKline after their child was born with a cleft lip and palate that required 10 surgeries to correct. The plaintiffs claim that if they had known about the dangers of Zofran, the mother would not have taken the drug to treat morning sickness.
These are just two examples of the hundreds of similar cases filed against the pharmaceutical company.
Zofran Lawsuits Working Their Way Through Court
Since 2015, hundreds of lawsuits have been filed in federal and state courts around the country. Eventually, the U.S. Judicial Panel on Multidistrict Litigation ordered all the federal cases to be consolidated in the U.S. District Court of Massachusetts as multidistrict litigation (MDL) because all the cases dealt with similar factual questions.
An MDL allows pretrial proceedings to take place together to increase the efficiency of similar lawsuits. It also makes it easier to set bellwether trials that will guide both sides toward a resolution.
As of March 2018,14 there are currently 429 actions pending in federal court under U.S. District Judge F. Dennis Saylor IV.
GlaxoSmithKline has attempted to get several cases related to Zofran dismissed while plaintiffs have asked the judge to force the company to hand over documents relating to what it knew about adverse effects caused by the drug.
More lawsuits are expected to be filed against GlaxoSmithKline in the coming months.