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Zofran (ondansetron) is a medication to treat nausea. It is an FDA approved drug from GlaxoSmithKline that blocks the actions of chemicals in the body that can trigger nausea and vomiting.
It is commonly given to individuals undergoing chemotherapy for cancer or just after surgery. It has proven to be an effective medication for this purpose. However, it has been prescribed to pregnant women to reduce nausea, even though it has not been approved to treat morning sickness. Zofran has been found to cause birth defects when taken by pregnant women.
Zofran works by blocking serotonin, a chemical that acts on the nerves in the gut to produce feelings of pain and nausea. It also increases the speed of food leaving the gut to reduce nausea and vomiting. But there have been reports of several birth defects caused by Zofran. If you are looking to file a claim for birth defects caused by this drug, contact our Zofran lawyers today to discuss your legal rights.
Availability and Approval of Zofran
Zofran, also know as ondansetron, has been approved by the by the United States Food and Drug Administration since 1991 for use in treating nausea. However, its approval is limited to use by cancer patients as well as surgery recoverers. Despite this limited FDA approval and the studies demonstrating the health concerns, doctors have been prescribing the drug for use in women who experience severe morning sickness, known as hyperemesis gravidarum, during their pregnancies.
What Are Complications Of Zofran?
Women in the first trimester of pregnancy commonly experience nausea, also known as morning sickness. For some women, it is particularly severe, and that condition is known as hyperemesis gravidarum. The manufacturer has been encouraging doctors to prescribe it off-label to pregnant women with nausea.
However, Zofran has been found to cause birth defects such as musculoskeletal problems, kidney malformations, intrauterine growth restriction (IUGR), mouth deformities, jaundice, and heart defects. Studies have found that there is a 30% increased risk of birth defects and a doubled risk of heart defects in infants when the mother takes Zofran while pregnant. There have been cases where the fetus has died.
In September 2011, the FDA announced that a 32 mg dose of Zofran can change the electrical chemistry of the heart and cause fatal heart rhythms.
Lawsuits are being contemplated by potential plaintiffs and their lawyers against the pharmaceutical company who manufactured Zofran and promoted its off-label use in pregnant women. GSK already settled with the FDA for $3 billion for paying kickbacks to doctors who prescribed it to pregnant women.
Zofran has been known to cause a wide variety of birth defects if taken during pregnancy. Potential complications include:
- Musculoskeletal problems
- Kidney defects
- Intrauterine growth restriction (IUGR)
- Mouth deformities
- Heart abnormalities
- Spinal malformations
Additionally, there have been cases where the unborn fetus has died as a result of the mother taking Zofran. Any documented birth defects can be helpful to discuss with with a lawyer for a claim against the manufacturers of Zofran.
Fetal Growth Restriction
Fetal growth restriction is a condition when an unborn baby weighs less than 90% of other infants at the same gestational age. Medical studies have shown that this condition can be caused when pregnant woman take Zofran during their pregnancy for nausea. This condition can cause permanent injury and harm to the baby and lawsuits are being filed against the drug maker for failing to warn physicians and women about this potential serious harm.
Signs and symptoms of fetal growth restriction may include:
- Low birth weight
- Difficulty handling delivery
- Decreased oxygen levels
- Low blood sugar (hypoglycemia)
- Low resistance to infection
- Low Apgar scores
- Trouble maintaining body temperature
- High red blood cell count
Intrauterine Growth Restriction
Recent medical studies have shown that Zofran taken by pregnant women can cause intrauterine growth restriction (IUGR), a condition when an unborn baby weighs less than 90% of other infants at the same gestational age. The drug has been prescribed to women during the first trimester of pregnancy to control nausea. The drug company failed to warn physicians and mothers about the possible birth defects associated with taking Zofran during pregnancy.
Intrauterine growth restriction is typically defined as a fetal weight below the tenth percentile for gestational age. It is also referred to as small-for-gestational age (SGA) or fetal growth restriction. There are two main types of IUGR:
- Symmetric or Primary IUGR – Characterized by a reduction in size of all internal organs. This form of the defect accounts for approximately 20% to 25% of all cases of intrauterine growth restriction.
- Asymmetric or Secondary IUGR – Head and brain are normal in size, but the abdomen is smaller. This form of intrauterine growth restriction is typically not observable until the 3rd trimester of pregnancy.
Treatment for IUGR depends on a number of factors, including how far along the mother is in her pregnancy. Many times, close monitoring is necessary and immediate delivery by C-section can be required to prevent further harm to the baby. The child may suffer long term problems from this condition.
Cleft palate and cleft lip, also known as orofacial clefts, are openings or splits in the upper lip, roof of the mouth, or both. These conditions occur when the developing facial structures in an unborn baby are unable to close all the way.
Cleft lip and palate are two of the most common birth defects. Most of the time they occur as isolated birth defects, but they can be associated with many different inherited genetic conditions and syndromes.
Congenital Heart Defect
The National Heart, Lung and Blood Institute states that congenital heart defect is a problem with the heart that occurs at birth. Congenital heart defects can involve the interior walls of the heart, the valves inside of the heart or the arteries and veins that carry blood to the heart. These sort of defects change the normal flow of blood through the heart. There are a wide variety of defects that range from simple defects with no symptoms to complex with life threatening symptoms.
Information on Zofran Lawsuits
Plaintiffs in the increasing number of Zofran lawsuits allege that GlaxoSmithKline knew about the risk of serious – and possibly even deadly – birth defects resulting from women using their drug during pregnancy. The lawsuits also allege that GSK promoted their drug for off-label use – specifically for use by pregnant women – despite knowing about these risks. In another lawsuit, the U.S. Department of Justice has also alleged that GlaxoSmithKline marketed their anti-nausea drug specifically for use in women who experience serious morning sickness during their pregnancies.
The U.S. Food and Drug Administration has not yet issued a recall for Zofran despite the fact that the drug has been linked to serious medical complications.
Many of these conditions affect newborn babies due to mothers using the drug during their pregnancy. Some of the potential side effects a newborn baby can possess are birth defects, musculoskeletal anomalies, jaundice, kidney malformation, and intrauterine growth restriction (IUGR).
In some rare cases, unborn fetuses have died due to complications caused by the drug. The FDA is still in the process of reviewing data and scientific studies to determine if the medication should be recalled from the market.
Although Zofran was not yet recalled, you can still pursue a lawsuit with an attorney’s help if you or someone you care about has been harmed by the drug.
Contact a Zofran Attorney Today
Manufactured by GlaxoSmithKline, Zofran (ondansetron) was approved to treat nausea during chemotherapy and following surgery. Zofran (ondansetron) works by blocking serotonin in the areas of the brain that trigger nausea and vomiting.
Between 2002 and 2004, GSK began promoting Zofran off-label for the treatment of morning sickness during pregnancy, despite the fact the drug has not been approved for pregnant women and there have been no well controlled studies in pregnant women.
The FDA has received nearly 500 reports of birth defects linked to Zofran. Birth defect risks include cleft palate and septal heart defects.
The criteria for filing a Zofran birth defect lawsuit with a lawyer include the following:
- Zofran taken during the first trimester of pregnancy
- Confirmed birth defect in infant, including:
- Heart defects
- Cleft-lip defects
Our Zofran lawyers can help if your child was harmed by this dangerous drug.