Health experts have named Zofran one of the most important medications in the world due to its usefulness in treating common symptoms of illness and bowel disorders. However, new reports show the manufacturer may have also pushed it for unapproved uses in pregnant women, putting babies at risk of severe birth defects.
As the FDA considers new warnings for Zofran, lawyers are now investigating cases against the maker of the drug and helping those families affected by birth defects learn their legal rights.
Zofran is the brand name for ondansetron, a medication developed by British drug giant GlaxoSmithKline in the mid-1980s. It was approved by the FDA for sale in the United States in 1991.
Ondansetron is classified as a 5-HT3 receptor antagonist. It works on the nervous system to block serotonin and speed up the transfer of food from the stomach to the small intestine. This helps reduce nausea and vomiting.
Zofran has a multitude of uses for palliative care, chief among them the prevention of nausea and vomiting in patients that have undergone chemotherapy or radiation treatment for cancer. It is also effective for those who have recently had surgery. Both uses are approved by the FDA.
Other uses for Zofran include limiting the cravings associated with alcoholism, lessening the effects of withdrawal from opioids, and relieving the symptoms of irritable bowel syndrome. It has also been prescribed extensively to reduce severe morning sickness in pregnant women.
Zofran is available in several dosages and forms, including a 4 mg and 8 mg pill, liquid form, an injection, or through intravenous pump.
The exclusive patent held by GlaxoSmithKline on Zofran expired in 2006, and several generic versions have entered the market since then. However, at its peak, Zofran was among the 20 top-selling drugs in the United States, with over $1.5 billion in sales each year.
Due to its relief of so many common symptoms associated with serious illnesses, ondansetron is listed as one of the few hundred essential medications by the World Health Organization.
Zofran is only approved by the FDA to relieve nausea and vomiting in chemotherapy and surgery patients. However, one of its chief uses has been for severe morning sickness in pregnant women.
Although the FDA has not approved Zofran for morning sickness, many doctors use it as a last resort when other medications fail to help. Doctors are allowed to write prescriptions for unapproved, or “off-label” uses on their own, but it cannot be suggested or promoted by drug companies.
It is estimated that around 75% of women experience nausea and vomiting during the early weeks of pregnancy. Approximately 1% suffer an extreme version of morning sickness called hyperemesis gravidarum (HG). HG involves uncontrollable vomiting that can cause severe dehydration, weight loss and limited nutrition. This requires hospitalization as it can put both the mother and baby at risk.
As many as 15% of pregnant women in the United States are prescribed medication to treat morning sickness, according to a recent study. Unfortunately, the majority of research suggests Zofran may increase the risks of certain birth defects when taken during the first trimester of pregnancy.
GlaxoSmithKline has been accused of promoting Zofran for use in pregnant women, and even paying doctors to prescribe it, in an attempt to broaden its use and increase profits.
In July 2012, GlaxoSmithKline pled guilty and paid a record settlement of $3 billion to the Department of Justice to settle charges that they illegally promoted drugs including Zofran for off-label uses, and paid doctors to prescribe them.
Although Zofran has been shown to help with symptoms of morning sickness, it is not approved by the FDA for use during pregnancy. In fact, only one medication, Diclegis, is approved for the treatment of morning sickness in pregnant women.
The FDA has classified Zofran as a “Pregnancy Category B” drug, meaning it has not shown a risk in animal studies, but also has not been proven safe. The current FDA guidelines are based on only 200 human births.
However, independent research has suggested that Zofran may be dangerous to a fetus when taken during the first trimester. Zofran has a high rate of passage from the mother through the placental barrier to fetal tissue.
Also, studies have shown that women taking Zofran have nearly double the risk of giving birth to babies with heart defects, cleft lip or cleft palate, and around 30% higher risks of birth defects in general. Before taking Zofran for morning sickness, it is important to review all the research data below, and talk with your doctor about the risks.
In June of 2012, GlaxoSmithKline enacted a voluntary recall of the 32 mg intravenous dose of Zofran due to cardiac risks. The change only involved the removal of the dosage instructions from the product label, not a recall of the product itself.
The change came after doctors and the FDA reported the single 32 mg IV dose could cause an irregular heartbeat known as QT interval prolongation. The condition, usually caused by drug side effects, can result in an irregular heart rhythm known as torsades de pointes, which can cause sudden death.
The dosage change only affected those patients prescribed Zofran for nausea and vomiting related to chemotherapy and radiation, not those who had recently undergone surgery. It was replaced with a maximum 16 mg dose at different intervals.
Although experts have warned that Zofran may also cause birth defects when taken during pregnancy, it has not been recalled by GSK or the FDA for this reason.
Data collected from over 22,000 women participating in the National Birth Defects Prevention Study from Arkansas, California, Georgia, Iowa, Massachusetts, New Jersey, New York, North Carolina, Texas and Utah suggests the risk of cleft palates was nearly doubled in babies whose mothers took ondansetron (Zofran) during the first trimester of pregnancy.
A study of data from 2,000 women who took Zofran among 600,000 births in Denmark from 2004-2011 found no significant increased risk of birth defects. However, half of the subjects were given the drug after the first trimester, once the risk of birth defects had passed.
Researchers re-examined the birth records from Denmark, but increased the size of the study to almost 900,000 women giving birth from 1997-2010, including nearly 1,250 women who had taken Zofran during their first trimester. This time, the results showed those taking the drug had twice the risk of having a baby with a heart defect, and a 30% higher rate of birth defects in general.
A study in the United States confirms earlier findings by Chinese doctors that Zofran has a high passage rate between mother and the fetus. With just three 8 mg doses, 41% of the drug dose passed to the fetus, a high concentration by comparison to other drugs. Researchers attributed this to the high concentration of Zofran that absorbs into fatty tissue.
Researchers from Sweden study nearly 1,350 babies born to mothers taking Zofran during the first trimester of pregnancy between 1998 and 2012. They find a 62% higher risk of giving birth to babies with atrial septal defects or ventricular septal defects, commonly known as “holes in the heart.”
Experts in the United States and Europe have discovered that Zofran may pose severe risks to fetuses when taken during the early stages of pregnancy.
First, the drug has an unusually high rate of transfer from the mother’s bloodstream to embryonic tissue and the fetus due to the fact it absorbs easily into fatty lipids. In fact, over 40% of the dosage can pass to the unborn child.
Second, research has shown the risk of heart defects and cleft palate defects may as much as double with Zofran use during the first trimester. After the first trimester, the risk falls significantly.
Although Zofran is not approved for use during pregnancy, reports show it has been prescribed widely for that purpose for decades. In 2012, GlaxoSmithKline settled federal criminal charges of promoting doctors to prescribe it for morning sickness, and even paying them to do so!
In December, an investigation into Zofran birth defects by the Toronto Star found FDA records showing a variety of side effects suffered by infants exposed to the drug. These included:
If your doctor has prescribed Zofran or ondansetron for severe morning sickness during pregnancy, it is important to recognize the potential risks. If your child suffered birth defects after you took it, you may be eligible to compensation from the manufacturer.
Designed to treat side effects from chemotherapy and cancer radiation, Zofran is considered one of the most effective treatments available for nausea and vomiting. For this reason, doctors have also turned to it when pregnant women have severe morning sickness.
For decades, this was thought to be a safe alternative use. Now, mounting new evidence shows that children whose mothers took Zofran during early pregnancy may have a higher risk of serious heart defects.
The first study to uncover these risks came in August of 2013, when researchers presented data to the International Society of Pharmacoepidemiology in Montreal, Canada. Reviewing records from more than 850,000 births in Denmark from 1997 to 2010, they found 1,250 women had taken Zofran during the first trimester. In these, the rate of heart defects was twice as high.
The results came as a shock to many doctors, especially since GlaxoSmithKline had encouraged them to prescribe it for treating morning sickness, a use not approved by the FDA. The year before, the company had paid $3 billion, the largest fine ever by a drug company, for illegally promoting Zofran and other drugs.
Then, in August of 2014, a new study from Sweden confirmed the earlier results, finding that infants whose mothers were prescribed Zofran during the first trimester had a much higher chance of being born with atrial and ventricular septal defects, or ASD and VSD.
ASD and VSD occur when an infant’s heart does not fully develop before birth. They are characterized by holes in the walls separating the chambers of the heart, which can significantly affect its ability to function. Heart defects like ASD and VSD can pose serious risks to newborns, and require several surgeries to correct. In rare cases they can even be fatal.
Talk with your doctor about all the risks involved before agreeing to take Zofran or ondansetron for morning sickness. If your child was born with a heart defect after you took the drug, you may be entitled to significant compensation for their care.
The use of Zofran (ondansetron) during early pregnancy has been linked to an increased risk of orofacial birth defects such as cleft palate.
The roof of the mouth normally forms in the middle of the first trimester, between the 6th and 9th weeks. Cleft Palate occurs when the bones of the skull do not join or fuse together properly to form the roof of the mouth.
The Centers for Disease Control estimates that around 2,650 infants are born with cleft palate each year. Although a definite cause of the condition has not been determined, it has been linked to smoking, diabetes and side effects from certain medications.
In 2011, researchers from the CDC and the Sloan Epidemiology Center in Boston studied data from over 22,000 women who took part in the National Birth Defects Prevention Study. They discovered that, among those who took ondansetron (Zofran) during the first trimester, the risk of having a baby with a cleft palate doubled.
Cleft lips and palates can be corrected, however they often require several expensive and painful surgeries during a child’s early years. They can also leave permanent scars.
The maker of Zofran has not advised pregnant mothers of the risk of cleft palates from taking the drug. In fact, they have promoted it for use in treating morning sickness, despite the fact it isn’t even approved by the FDA for use during pregnancy.
Manufacturers of dangerous medications may be held liable for damages when they knowingly sell a harmful product, fail to warn consumers or doctors of the risks, or conceal information that could have warned the public.
Reports now show that for years, GlaxoSmithKline promoted Zofran for use in pregnant women, even paying doctors to prescribe it, despite the severe risk of birth defects.
While Zofran has helped millions of people suffering the nausea side effects of cancer treatment and surgery, research has suggested it is not safe for use in the early stages of pregnancy.
Lawyers are currently investigating lawsuits against GlaxoSmithKline on behalf of those families affected by birth defects after Zofran use.
It costs nothing to talk with a lawyer, investigate your claim or file a lawsuit unless you receive a verdict or settlement.
The patient advocates at DrugNews can answer more questions about this drug and the current litigation, and let you speak with a lawyer today.
Injured by Zofran? Speak with a lawyer who specializes in the Zofran birth defect litigation.
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