What the Zofran Justice TV commercial - Zofran Birth Defect Warning is about.
Zofran is a prescription drug commonly used to treat nausea and vomiting caused by chemotherapy, radiation therapy, and surgery. However, there have been reports of Zofran causing birth defects in infants whose mothers had taken the medication during pregnancy. This has led to several lawsuits against Zofran's manufacturer, GlaxoSmithKline.
The Zofran Justice TV spot titled 'Zofran Birth Defect Warning' is a public service announcement that aims to warn pregnant women of the potential risks associated with using Zofran during pregnancy. The TV spot features a mother who talks about how her child was born with heart defects after she had taken Zofran during pregnancy. The mother urges other women to speak to their doctors about alternative treatments and to research any medication they may be prescribed.
The Zofran Justice TV spot serves as a warning to expectant mothers about the potential dangers of using certain prescription medications during pregnancy. It reminds them that they should always consult with their healthcare provider to make informed decisions about the safety of any medication they are prescribed. The commercial also serves to hold GlaxoSmithKline accountable for the harm caused to mothers and their children due to the use of Zofran during pregnancy. Overall, the Zofran Justice TV spot aims to raise awareness about the potential risks associated with the use of certain medications during pregnancy and to promote safe and informed decision-making.
Zofran Justice TV commercial - Zofran Birth Defect Warning produced for
Pharmaceutical Justice
was first shown on television on April 12, 2015.
Frequently Asked Questions about zofran justice tv spot, 'zofran birth defect warning'
Zofran is not approved by the FDA for preventing morning sickness in pregnant women. Why? Because there is no data was ever presented that this is a safe drug for women carrying a vulnerable fetus.
The U.S. Court of Appeals for the First Circuit affirmed the entry of summary judgment in favor of GlaxoSmithKline (GSK) in the Zofran multidistrict litigation (MDL) on January 9, 2023. The MDL involved over 400 lawsuits alleging that GSK failed to warn that Zofran could cause birth defects if taken by pregnant women.
FDA Drug Safety Communications & Zofran Recall
In 2012, the 32 mg intravenous dose of Zofran was pulled from the market due to concerns that it could trigger QT interval prolongation, a heart rhythm disorder that could lead to an abnormal and potentially fatal heart rhythm called Torsades de Pointes.
Zofran is an anti-nausea medication often prescribed off-label to women during pregnancy. Sadly, studies link birth defects to Zofran and its generic version ondansetron. The drug's warning label does not list the increased risk of causing birth defects.
Zofran is approved by the Food and Drug Administration (FDA) for use to fight off nausea related to chemotherapy. It is not currently approved by the FDA for morning sickness. Even so, most studies show that ondansetron is safe to use during the first trimester when most women experience morning sickness.
Although large studies have concluded that the medication doesn't appear to cause birth defects or other health problems in babies, some research has linked Zofran to a very small (less than 1 percent) increase in the chance of a baby developing cleft palate and heart defects.
Even so, most studies show that ondansetron is safe to use during the first trimester when most women experience morning sickness. A Danish study published in The New England Journal of Medicine in 2013 showed that Zofran did not increase the risk of the following in most pregnancies: Low birth weight.
Most studies have not reported an increased chance for birth defects among thousands of people who used ondansetron in pregnancy.
Zofran® (ondansetron) is a medication that prevents nausea and vomiting caused by chemotherapy, radiation or surgery. It blocks substances in your body that can cause nausea and vomiting. You can take this medication by mouth after using a specially marked spoon or container to measure your medication.
Zofran is listed as a Category B medication for pregnancy. Pregnancy Category B indicates that the medication has not been proven safe for use in pregnancy but animal studies have not indicated toxicity. However, many women have been prescribed Zofran for morning sickness and some have experienced birth defects.
Based on recent studies regarding the association between Zofran use in early pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has cautioned against its use in pregnancy.
Most studies have not reported an increased chance for birth defects among thousands of people who used ondansetron in pregnancy. A few studies reported a very small (less than 1%) increase in the chance for a cleft palate (an opening in the roof of the mouth that can be repaired with surgery) or a heart defect.
