Studies Link Zofran to Birth Defects

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Zofran is the brand name of a drug that doctors prescribe to control nausea and vomiting. Known generically as ondansetron, Zofran is approved by the Food and Drug Administration (FDA) for administration to cancer patients to relieve the effects of chemotherapy, radiation therapy, and cancer surgery. Because Zofran can change the heart’s electrical activity, causing the heart to beat in an abnormal rhythm, the FDA has warned doctors to exercise caution when prescribing Zofran, particularly when patients suffer from a heart condition, have low levels of potassium or magnesium in their blood, or take certain medications.

While Zofran is only approved for use in cancer patients, many physicians have prescribed Zofran to relieve the symptoms of morning sickness experienced by pregnant women. Since electrolyte imbalances involving magnesium or potassium may be a problem for pregnant women, any woman who takes Zofran during pregnancy should ask her doctor whether it is safe for her to take the drug. In addition, a growing body of evidence suggests that using Zofran during the early months of pregnancy increases the risk of giving birth to a child who suffers from birth defects. For both of those reasons, organizations like The College of Family Physicians of Canada are cautioning doctors not to prescribe Zofran to pregnant women.

Zofran and Morning Sickness

Ondansetron controls nausea and vomiting by suppressing the effects of serotonin. While the suspected link between depression and serotonin manufactured in the brain has been well publicized, most of the body’s serotonin is produced in the intestines, where it plays a significant role in the digestion of food. The release of a large amount of serotonin in the digestive tract triggers a vomiting reflex and causes feelings of nausea. Since the small intestine responds to certain cancer treatments with a flood of serotonin, Zofran can help cancer patients by preventing or limiting the nausea and vomiting that serotonin produces.

Doctors have increasingly prescribed Zofran to pregnant women in the belief that it would control morning sickness. Some of those doctors may have been encouraged to do so by the drug’s manufacturer, GlaxoSmithKline (GSK). Because the FDA has not approved Zofran as a treatment for morning sickness, GSK is not allowed to advertise or promote the drug for that purpose or for any other “off label” use. The Justice Department nevertheless brought a lawsuit against GSK, alleging that GSK did exactly that by paying doctors to prescribe Zofran to pregnant women who suffer from morning sickness. GSK settled the lawsuit, which also alleged a host of other civil and criminal violations, for $3 billion. As is common in civil settlements, GSK admitted no wrongdoing.

Despite the absence of FDA approval for the use of Zofran to combat morning sickness, doctors were prescribing ondansetron to more than one hundred thousand pregnant women each month by the end of 2013. Whether it is safe for pregnant women to take Zofran is a controversial subject. Until the FDA has evaluated the health risk of taking Zofran during pregnancy, women should ask their doctors about alternative drugs that have a track record of safety when used to control morning sickness.

Zofran and Birth Defects

Scientists who have studied the effects of ondansetron during pregnancy have reached inconsistent results. A study in Denmark (known as the Pasternak study) found no significant link between Zofran and birth defects while a follow-up study (known as the Andersen study) concluded that taking ondansetron during the first trimester of pregnancy doubled the risk of giving birth to a child with a serious heart defect. The different conclusions may be caused in part by the failure of the first study to focus on the ingestion of ondansetron during the early weeks of pregnancy, when its impact on fetal development is likely to be greatest, and in part by the small number of pregnancies upon which conclusions were based.

A study that was conducted jointly by the Slone Epidemiology Center and the Center for Disease Control and Prevention found a twofold increase in children born with cleft palates to mothers who took ondansetron during the first trimester of pregnancy. The most recent study (known as the Danielsson study) focused on Swedish infants whose mothers took ondansetron in early pregnancy. That study concluded that a statistically significant increase in children born with heart defects is associated with the use of ondansetron during pregnancy.

A review by the Toronto Star of FDA records found many reports of birth defects that may be associated with Zofran. In addition to cleft palates and other deformities of the mouth, the risk of giving birth to a child with an atrial septal defect, or a hole in the heart, appears to be significantly associated with the use of ondansetron during pregnancy. Reviewing the available evidence, an article in Canadian Family Physician concluded that “ondansetron use cannot be assumed to be safe during pregnancy.”

Zofran Lawsuits

Mothers who gave birth to children suffering from birth defects after taking Zofran during pregnancy are filing lawsuits against GSK. Based on the available scientific evidence, lawsuits have particular merit when children are born with a cleft palate or a heart defect, including an atrial septal defect (ASD) or a ventricular septal defect (VSD).

Children born with a “hole in the heart” may experience shortened lifespans due to heart failure. They may also have problems with high blood pressure later in life. Congenital heart defects increase the risk of stroke as well as shortness of breath caused by pulmonary hypertension.

Surgery may be needed to correct birth defects associated with a pregnant woman’s use of Zofran. Follow-up care by heart specialists or speech therapists may be necessary as a child grows to adulthood. A personal injury lawyer can help families obtain the money they need to pay for those expenses. An attorney can also help children receive compensation for any pain and suffering or emotional distress they endure as the result of their birth defects.

It is important to act promptly if you or your child may have been injured as the result of taking Zofran. The time for making a claim is limited. Seeking a prompt evaluation of your claim by a personal injury attorney will help you preserve your right to compensation.

 

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