Zofran

birth defects including cleft lip, cleft palate and heart defects

ABOUT THE DRUG

Zofran (ondansetron) is a prescription medication that prevents or treats nausea and vomiting. It is one of a type of medication called anti-emetics, and Zofran belongs to a class called 5HT3 receptor antagonists. The drug works by blocking a neurotransmitter called serotonin in the areas of the brain that trigger nausea and vomiting. The drug works by blocking a neurotransmitter called serotonin in the areas of the brain that trigger nausea and vomiting. Manufactured and sold by GlaxoSmithKline, it was the first in its class on the market, and the U.S. Food and Drug Administration (FDA) approved it in 1991.

While the drug is only approved for use in treating nausea and vomiting after chemotherapy, radiotherapy or after surgery, doctors use it for off-label (unapproved) uses such as treating stomach problems in children and morning sickness in expectant mothers. About 80 percent of pregnant women experience nausea and vomiting during pregnancy (NVP). The most serious form of NVP, called hyperemesis gravidarum, can lead to malnutrition and dehydration dangerous for both the mother and the baby.

PURPOSE OF THE DRUG

Zofran blocks the actions of chemicals in the body that can trigger nausea and vomiting. Zofran is used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy or radiation) and is not for preventing nausea or vomiting that is caused by factors other than cancer treatment or surgery.

WARNINGS

Zofran has proven to be an effective medication to treat nausea and vomiting, but the medication never gained federal approval to be prescribed to pregnant women. Despite the lack of approval, women battling morning sickness have taken the drug, which some families claim led to birth defects.

SIDE EFFECTS

Some mothers found out too late about the dangers of the drug. Zofran is 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. 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 cleft palate, heart defects, mental problems, impaired vision, among others.

HOW SHIFFMAN & SHIN CAN HELP

About 1 million pregnant U.S. women take Zofran each year for a short-term solution without knowing the potentially life-altering long-term damage to their children, says Lonny Shiffman Shin Law.

Women who were prescribed Zofran during their pregnancies and whose children were born with some form of birth defect should seek legal counsel immediately, Shiffman advises.

It heartbreaking to hear from mothers claiming they were misled and lied to about the drug’s risks and safety, says Shiffman Shin. These women have been betrayed in the worst way imaginable, and it’s our job to help them understand their legal rights and the steps they can take to somehow alleviate the tragedy of this deception and the long-term ramifications for their children.

Given the results emerging in the last few years linking Zofran to congenital birth defects, mothers and families of babies born with serious mental and physical deformities are now turning to Shiffman Shin Law to pursue lawsuits against the drug manufacturer.

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