Zofran Birth Defects Lawsuit Lawyer
Please note: Our law firm no longer accepts Zofran cases.
Zofran taken during pregnancy increases the risk of birth defects, including heart defects, cleft lip, cleft palate. An anti-nausea drug, Zofran (generic: ondansetron) is sometimes prescribed off-label to pregnant women for morning sickness. A study published in Pub Med Dec. 2014 showed Zofran taken during pregnancy increased risks, judged “statistically significant,” for a cardiovascular birth defect and “likely” for a cardiac septum birth defect.
Zofran Birth Defects
A Toronto Star investigation published June 2014 reported 20 Canadian women who took Zofran while pregnant gave birth to babies born with birth defects, including heart defects, kidney malformation, musculoskeletal abnormalities, mouth deformities, Jaundice, fetal growth restriction, fetal death.
Zofran not proven Safe for Pregnant Women
The FDA rates Zofran a “Pregnancy Category B” drug, which means no adequate or well-controlled studies show Zofran safe for pregnant women. GlaxoSmithKline did produce some fetal safety data; but with fewer than 200 births, it is not definitive.
The New England Journal of Medicine (NEJM) published a study in Feb. 2013 which showed Zofran used during pregnancy did not not increase the risk of birth defects; but half of the women in the study took the drug only after the 10th week of pregnancy. The first trimester (the first 12 weeks) of pregnancy has typically been the benchmark to determine whether or not a mother’s drug ingestion contributes to a risk of birth defect(s).
Six months after that small NEJM study was published, other researchers examined the same database of pregnancy outcomes. Those researchers found Zofran doubled the risk of heart defect, or increased birth defect risk by 30%. Roughly 5% of babies exposed to Zofran were born with a birth defect, compared to 3.5% of babies not exposed to Zofran in utero.
Zofran doubles Risk of Cleft Palate
Birth Defects Research published in Jan. 2012 showed Zofran during pregnancy linked to a 2.4-fold increased risk of cleft palate. Some 9,000 pregnant women were enlisted in that National Birth Defects Prevention Study.
Heart Defect Risks Doubled in 2013 Study
A study published Oct. 2013 examined 900,000 pregnancies and some 1,250 women who used Zofran during their first trimester. Researchers found babies born to these mothers showed a two-fold increase in heart defect risks.
Types of Zofran Heart Defects:
• Atrial Septal Defect (ASD) is a “hole in the heart” defect which allows blood to pass between the two upper chambers (atria) of the heart. Large defects can cause lung damage over time, in addition to low oxygen levels in the blood, life-threatening complications.
• Ventricular Septal Defect (VSD) is a hole between the two lower chambers (ventricles) of the heart. It is much less common than ASD, but some babies can suffer both defects.
• Heart Murmur is any abnormal sound in a baby’s heart heard through a stethoscope. Different heart defects produce different sounds.
Zofran Indications (to prevent)
• nausea, vomiting associated with highly emetogenic cancer chemotherapy.
• nausea, vomiting associated with initial and repeat courses of cancer chemotherapy.
• nausea, vomiting associated with radiotherapy in patients receiving full body irradiation, single abdominal high-dose fraction or daily abdominal fractions.
• postoperative nausea, vomiting.
Generic versions of Zofran became available in Jan. 2007. Ondansetron is the generic name and the main active ingredient in Zofran. Everyone knows that generic drugs are usually cheaper than brand name drugs, but few people know that generic drug makers, unlike branders, are typically not held liable when a generic drug injures someone. In addition, even though FDA considers generic drugs “equivalent” to their brand name counterparts, many anecdotal reports of brand name drugs that have gone generic continue to be heard around the country. From a legal perspective, we do know, unfortunately, that generic drugs are not equivalent to brand name drugs.
Zofran Maker fined $3 Billion by Justice Dept.
The U.S. Justice Department ordered Glaxo Smith Kline (GSK) to pay $3 billion in July 2012 for illegally marketing several drugs “off-label,” which means GSK marketed the drugs for unapproved uses. This fine represents the largest health care fraud penalty in U.S. history, also the largest payment any drug company ever made. The company was also fined for illegally paying kickback money to doctors for prescribing GSK drugs.
Zofran promoted off-label for Morning Sickness
Zofran is promoted to treat severe morning sickness, despite a lack of long-term safety studies regarding Zofran use in pregnancy. The video below identifies that lack of long-term safety studies, yet claims Zofran is safe based on anecdotal evidence, which, in a court of law, is virtually never permitted as proof of a drug’s safety (or of its actual risks). The video promotes Zofran as one of the few anti-nausea medications that does not make a pregnant woman sleepy. The video also identifies and forgives Zofran’s side effect of significant constipation by stating that constipation is a common pregnancy side effect regardless of Zofran use.
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Zofran Lawsuit Updates
We will keep you up to date on any Zofran class action lawsuits, additional FDA Zofran warnings, and Zofran FDA recall announcements.
Class Action vs. Individual Zofran Lawsuits
Matthews & Associates files Zofran lawsuits on a case-by-case basis. Each must stand on its own merits. Some litigation offers advantages for filing cases in a class action, but we believe that individual cases offer plaintiffs the best chance for maximum recovery of damages in Zofran Lawsuit claims. Please see our Frequently Asked Questions (#9) for a discussion of the merits of class action lawsuits vs. individual lawsuits.
- Zofran generic is not equivalent to Zofran
- Zofran Birth Defect Risks
- Zofran Usage, Dosage, Side Effects – Drugs.com
- Zofran Side Effects Center
- Zofran Drug Safety Communication – FDA
- Odansetron in Pregnancy, Risk of Adverse Outcomes – NEJM 2013
- Zofran FDA Drug Safety Communication – 2012 update
- Zofran and Abnormal Heart Rhythms – 2011
- Zofran Prescribing Information – FDA
- Birth Defect Drugs
- $3 Million Verdict in Birth Defect Drug Lawsuit
- Pub Med Dec. 2014: Increased Birth Defect Risk for Zofran in Pregnancy
- GlaxoSmithKline knew Zofran Pregnancy Risks