Zofran is commonly prescribed to control nausea in cancer patients who are undergoing chemotherapy and other forms of treatment. More recently, it has been prescribed to pregnant women to control morning sickness. Both uses of the drug carry risks.
The possibility that Zofran will injure pregnant mothers or their unborn children is a growing concern. The Justice Department sued the company that manufactures Zofran for promoting it to doctors as a remedy for morning sickness, a use of the drug that federal drug regulators have not approved. Women who took Zofran during pregnancy have also sued the manufacturer after giving birth to children who suffer from birth defects.
What is Zofran?
Zofran and Zofran ODT are brand names of an anti-nausea medication known generically as ondansetron. Ondansetron belongs to a class of drugs called “setrons” that suppress the effects of a neurotransmitter called serotonin. While serotonin that is manufactured in the brain has been linked to depression and other mood disorders, most of the body’s serotonin is located in the gastrointestinal tract, where it regulates intestinal movements. A rapid increase of serotonin in the digestive tract initiates a vomiting reflex and induces feelings of nausea.
Zofran is prescribed in the form of a tablet or an oral solution. Zofran ODT is an orally disintegrating tablet, a tablet that dissolves on the tongue so that a patient does not need to swallow it whole. Zofran is manufactured by GlaxoSmithKline (GSK), a British pharmaceutical company.
Who Takes Zofran?
Zofran is commonly prescribed to cancer patients who are undergoing treatment. Some forms of chemotherapy and radiation therapy stimulate the rapid production of serotonin. Zofran helps control nausea and blocks the vomiting reflex in those patients. Patients who have had cancer surgery may also receive Zofran to prevent postoperative nausea and vomiting. The Food and Drug Administration (FDA) has approved the use of Zofran to control nausea produced by cancer treatment
Many doctors prescribe Zofran to help expectant mothers control morning sickness. The FDA has not approved Zofran to relieve morning sickness because its safety, when taken by pregnant women, has not been established. Still, by the end of 2013, ondansetron was being prescribed to more than 110,000 pregnant women each month, up from 50,000 per month in 2008.
Doctors are entitled to use their own judgment when prescribing a drug for an unapproved (“off-label”) purpose, but a drug cannot legally be marketed for an off-label purpose. According to a lawsuit filed by the Justice Department, GSK illegally promoted Zofran’s off-label use as a treatment for morning sickness. The lawsuit also alleged that GSK paid kickbacks to doctors to induce them to prescribe Zofran and other drugs. GSK paid $3 billion to settle civil and criminal claims brought by the Justice Department, including the allegations concerning Zofran.
Is Zofran Safe?
There are risks associated with both the approved and unapproved uses of Zofran. One of the risks involves the potential impact that Zofran has on the heart’s electrical activity. After reviewing the available evidence, the FDA issued a safety announcement to inform the public that taking Zofran may lead to abnormal heart rhythm, including a condition known as Torsade de Pointes. The changes in the heart’s electrical activity are characterized by a rapid and irregular heartbeat. The effect is potentially fatal.
Patients who have the greatest risk for developing abnormal heart rhythms after taking Zofran include:
- patients with heart conditions, including congenital long QT syndrome and congestive heart failure
- patients who have low levels of potassium (hypokalemia) and magnesium (hypomagnesemia) in their blood
- patients who take medications that prolong the heart’s QT interval (a measurement of the heart’s electrical cycle)
The other potential health risk arises when Zofran is administered to expectant mothers. A comprehensive review of FDA records by the Toronto Star highlighted reports that babies born to women who took Zofran during the first trimester of pregnancy suffered from birth defects, including “atrial septal defect,” or a hole in the heart.
Studies of Zofran’s safety when taken by pregnant women have produced mixed results. One recent study in Denmark found a doubling of major heart defects in children whose mothers took ondansetron during the first trimester of pregnancy. Another study found no increase in certain birth defects after mothers took ondansetron during pregnancy but concluded that the likelihood of a child being born with a cleft palate doubled. Studies that have discounted the risk of birth defects may be problematic because of their small sample size or because they did not focus on the use of ondansetron during the first trimester, when fetal development is most likely to be impaired by the mother’s use of unsafe medications.
What You Should Do if You Take Zofran
If you have been taking Zofran, talk to your doctor about the risks and benefits of the drug. Make sure your doctor is aware of all other medications you are taking. If you have been diagnosed as having a heart condition, make sure the doctor who prescribed Zofran is aware of that condition. If you have not had an electrocardiogram since you began taking Zofran, ask your doctor whether you need one.
Whether you have been taking Zofran to relieve the symptoms of morning sickness or cancer treatment, you should contact your doctor immediately if you experience any symptoms that may be associated with abnormal heart rhythm, including:
- shortness of breath
- a sudden awareness of your heartbeat
- a feeling that your heart is beating unusually fast
If you are pregnant, you should talk to your doctor about alternatives to Zofran. Other drugs are available to control of morning sickness. Ask your doctor whether you should take one of those drugs instead of Zofran. If your doctor insists that there is no risk to your unborn child, get a second opinion.
Compensation for Injuries Caused by Zofran
Lawsuits against GSK allege that Zofran caused birth defects in children born to mothers who took the drug during pregnancy. Heart problems and cleft palates are the most common birth defects upon which lawsuits have focused. Several lawsuits are pending but many more are expected to be filed in the coming months and years, given the number of pregnant women to whom Zofran was prescribed.
A child who is born with a heart problem or other birth defect may require years of specialized medical care. The expense of providing that care can be financially crippling. Parents of children who suffer from birth defects caused by Zofran seek compensation from lawsuits to assure their children receive the care they need.
If you are concerned that you or your child may have been injured because you took Zofran, talk to a personal injury lawyer right away. Since tight deadlines limit your ability to file a lawsuit, delay could cause you to lose your ability to make a claim for the compensation to which you are entitled. The attorneys at Advocate Law Group have decades of experience handling product liability and personal injury claims. We work with leading product liability firms nationwide to help our clients obtain results. Contact us for a free case evaluation.