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Zofran Birth Defects: Frequently Asked Questions

By Andrew Sullo


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If you are a woman who was prescribed the drug Zofran for morning sickness and your baby was born with a birth defect, you may have Zofran birth defect questions. Zofran (Ondansetron) is marketed by GlaxoSmithKline and was approved by the FDA to treat chemotherapy and radiation patients who experienced nausea and vomiting. Doctors become aware of potential off-label uses for drugs from a variety of sources, including published medical research and word-of-mouth from their peers. It is, however, illegal for drug companies to promote off-label uses of any drug to physicians. GlaxoSmithKline apparently ignored those laws and ended up paying a $3 billion settlement to the U.S. Department of Justice in 2012 for promoting the off-label use of Zofran. If you are looking for Zofran birth defect answers the following frequently asked questions about Zofran may help.

 

What is Zofran?

Zofran (Ondansetron) is a drug which blocks the actions of chemicals in the body which can trigger nausea and vomiting. Zofran should not be used in those with intestinal obstructions, decreased liver function, show or irregular heartbeat, those with electrolyte imbalances, those having surgery on the adenoids or tonsils and those with a family history of abnormal heart rhythm known as prolonged QT interval. Zofran should also not be used in those with a known hypersensitivity or allergy to the ingredients in Zofran, or those with lactose intolerance.

 

Who Manufactures Zofran?

Zofran is manufactured by GlaxoSmithKline, a British multinational pharmaceutical company. GSK’s headquarters are in Brentford, London, and as of March, 2014 it was the world’s sixth-largest pharmaceutical company.

 

How Does Zofran Work?

Zofran contains the active ingredient Ondansetron hydrochloride dehydrate—a type of medication known as a 5HT3 antagonist. The vomiting reflex is controlled by a specific area of the brain which is activated when it receives nerve messages from the chemoreceptor trigger zone of the brain and from the stomach. During chemotherapy, radiation and surgery, the 5HT3 receptors are activated, causing messages to be sent to the vomiting brain center. Zofran blocks the receptors in the brain and the stomach, preventing the nausea messages.

 

What are the Side Effects of Zofran?

About one in ten people taking Zofran will experience a headache, while slightly more will experience flushing, warmth sensations and constipation. Between one in a hundred and one in a thousand people taking Zofran will experience seizures, involuntary movements, slow or irregular heartbeat, chest pain, negative alterations in liver function, and uncontrollable hiccups. Rarely, a person taking Zofran will experience visual disturbances, abnormal heart rhythm and serious allergies.

 

How is Zofran Taken?

Zofran comes in tablets, syrup, tablets that melt on the tongue, intramuscular injection, and suppository form or by IV infusion. Tablets and syrup can be taken with or without food.

 

What is Zofran Approved for by the FDA?

Zofran was first approved in 1991 for the nausea and vomiting associated with chemotherapy, radiation and some types of surgical procedures. Reportedly, the only data GSK submitted to the FDA on the issue of birth defects were from experiments conducted in 1984 and 1985 with rats and rabbits. This data is highly questionable, since rats have a gestation period of 21 days, and rabbits have a gestation period of 33 days. This means that for rats the “first trimester” would be one week and for rabbits it would be eleven days—a narrow window of time. The rats in the first two studies were given Zofran for ten days, beginning on the seventh day, effectively skipping most of the first trimester. In the two studies on rabbits, Zofran was not given until the eighth day, once more nearly skipping the first trimester. In humans, studies have shown it is during the first trimester that cleft lip and palate as well as heart defects can occur. 

 

What is Off-Label Use?

While Zofran is not approved for use by pregnant women, it is sometimes prescribed off-label to treat morning sickness experienced by as many as 15% of women during the first trimester of pregnancy. Severe morning sickness is called hyperemesis gravidarum; a condition characterized by severe nausea, vomiting, electrolyte disturbances and weight loss. Milder cases of morning sickness are generally treated with dietary changes and rest, however severe cases can require a hospital stay and IV hydration and nutrition.

 

Most all women will experience some level of morning sickness, but fewer experience such severe nausea. It is believed morning sickness is due to the fluctuations of hormones during the pregnancy. Doctors are ethically and legally allowed to prescribe drugs off-label, and in the case of Zofran, GlaxoSmithKline actively advertised the drug to combat morning sickness even though it was not FDA approved for that use. 

 

What Zofran Studies Point to a Link to Birth Defects?

A Danish study involving 900,000 births found a 30% increased risk of Zofran birth defects and doubled risk of heart defects. In 2012, a study from the Center for National Birth Defects Research and Prevention found a 2.4 times increased risk for cleft palate and cleft lip when Zofran was used during the first trimester. A 2014 investigation by the Toronto Star found at least 20 women living in Canada reported serious Zofran side effects to the FDA. These included multiple cases of heart and kidney birth defects and two infant deaths.

 

What Types of Birth Defects Could Zofran Be Responsible For?

Some of the potential Zofran birth defects include heart and kidney defects, musculoskeletal defects, poor fetal growth, cleft lip and palate, jaundice and fetal death.

 

Should I File a Zofran Birth Defect Lawsuit?

If you believe your baby’s birth defect was caused by Zofran, you should speak to a knowledgeable Zofran birth defect lawyer to get answers to your questions. Potential lawsuits are currently being evaluated against the manufacturer of Zofran.

 

Do I Need a Zofran Birth Defect Lawyer?

It could be beneficial to speak to a Zofran birth defect lawyer in order to find out whether you should consider filing a Zofran lawsuit.
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