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Zofran, Zuplenz and the generic version ondansetron are labeled as Pregnancy Risk Category B, meaning there is no evidence of risk to humans. Many mothers took this assurance to mean the drug was safe, but multiple studies show evidence to the contrary. Because Glaxo never proved Zofran was safe, the FDA never gave an approval to market the drug to pregnant women. Regardless, Glaxo continued to advertise its anti-emetic for morning sickness.
Some mothers found out too late about the dangers of the drug. In studies and lawsuits filed by mothers and families of injured babies, a number of side effects are linked to the medication, including:
|Birth Defects Linked to Zofran|
|Mental problems||Physical deformities||Hearing Loss|
|Vision problems||Heart defects||Abnormal blood pressure|
|Stomach problems||Cleft lip||Cleft palate|
|Club foot||Webbed toes||Skull deformities|
In December 2014, Dr. Gideon Koren published the findings of his Zofran study review in the American Journal of Obstetrics and Gynecology. Among the results he presented was a 2013 study of 900,000 Danish women that found a "2-fold increased risk of cardiac malformations with ondansetron (including Zofran and Zuplenz), leading to an overall 30 percent increased risk of major congenital malformations."
Before this, in 2011 a large control study by the Slone Epidemiology Center in Boston, Mass, and the Centers for Disease Control and Prevention revealed a 2-fold increase in the risk of cleft palate defects when women took Zofran and other versions of the drug during the first trimester.
According to court documents, Glaxo's own clinical data in animal studies from its early applications for Zofran FDA approval in the 1980's showed "clinical signs of toxicity, premature births, intrauterine fetal deaths, and impairment of ossification (incomplete bone growth)." Some of the animals also showed evidence of congenital heart defects and developmental retardation.
The drug can also cross the placental barrier and be excreted in breast milk. In tests, fetal tissue samples showed about 41 percent of the concentration of Zofran in the mother's blood – according to court documents, this is enough to cause fetal malformations.
This occurs when too much serotonin is present in the body. This is a serious condition that can be life-threatening. Symptoms include high fever, irregular heartbeat, seizures and unconsciousness.
Zofran can affect the electricity in the heart, causing erratic heartbeats that can be fatal.
|Other serious side effects include:|
|Blurry vision||Shortness of breath|
|Loss of consciousness||Chest pain|
|Hives or rash||Swelling|
|More common side effects are:|
In 2012, the FDA issued a recall for the 32 mg intravenous dose of Zofran because of the "potential for cardiac risks." The oral versions of the drug were not affected. The abnormal rhythm disorder is called QT interval prolongation and can lead to Torsades de Pointes an abnormal, potentially fatal heart rhythm.
Women who are pregnant or who plan on becoming pregnant should be extremely cautious with the drugs they take. Prescription medications and over-the-counter drugs can affect the development of a fetus and affect a pregnant woman differently than a woman who is not pregnant.
It is very common for pregnant women to experience morning sickness during the first trimester. Some home remedies for treating morning sickness include eating light snacks throughout the day or sipping ginger ale to relieve nausea. It’s also highly recommended that all pregnant women stay hydrated and take prenatal vitamins for nutritional needs.
Women who experience hyperemesis gravidarum, or NVP, may require hospitalization and intravenous (IV) fluids. In some cases, a doctor may prescribe vitamin B-6 supplements, antihistamines or other anti-nausea drugs. Women should ask their doctor about all potential side effects of an anti-nausea drug and ask if it is FDA approved for use in pregnant women before agreeing to the treatment.
Taking Zofran during pregnancy can lead to harmful complications including birth defects. If you or your loved ones were harmed by Zofran, you may have legal options. Tell us about your experience and we will provide you with a free case review.