If you or a loved one have suffered an injury or worsened health conditions after taking Zofran, you may be entitled to financial compensation through a Zofran lawsuit.
Manufactured by GlaxoSmithKline, Zofran (also known as Ondansetron) was approved for use by the U.S. Food & Drug Administration in 1991 to treat nausea and vomiting associated with cancer chemotherapy, surgery, and radiation therapy.
It has also been used off-label to treat morning sickness during pregnancy, even though the Food and Drug Administration (FDA) never approved the use of Zofran for morning sickness during pregnancy.
By 2009, Zofran became the most prescribed morning sickness medication in the United States.
The current Zofran lawsuit alleges that GlaxoSmithKline actively marketed the drug off-label as a safe and effective treatment for a common side effect of normal pregnancy (pregnancy-related nausea and vomiting, or morning sickness).
The Zofran lawsuit makes allegations that the company engaged in unethical practices by promoting Zofran to pregnant mothers while failing to undertake a single study on the effects of Zofran on pregnant mothers or their unborn children.
In this sense, pregnant mothers and their unborn children were arguably the test subjects for the drug.
Plaintiffs also allege that GlaxoSmithKline was actually aware that Zofran was unsafe for ingestion by pregnant women based on animal studies done in the 1980s, which revealed evidence of toxicity, intrauterine deaths, and malformations in offspring.
Plaintiffs also assert that this evidence was supported by reports of birth defects submitted to GlaxoSmithKline in the 1990s and 2000s.
In February 2015, two zofran lawsuits were filed in federal courts alleging that the use of Zofran during pregnancy increases the risk of birth defects.
These lawsuits are aimed at GlaxoSmithKline LLC, the maker of Zofran, and seek compensatory and punitive damages, equitable relief, and other relief deemed just and proper arising from the injuries as a result of prenatal exposure to Zofran.
In 2012, GlaxoSmithKline pled guilty to criminal charges lodged by the United States Department of Justice for its off-label promotion of Zofran for uses never approved by the FDA.
GlaxoSmithKline also entered civil settlements and had to pay a $3 billion settlement for the company’s unlawful promotion of several prescription drugs, including Zofran, as well as paying doctors to prescribe the drug.
The settlement will compensate plaintiffs who allege that they were encouraged to use these drugs, but it does not compensate them for alleged injuries resulting.
The Center for Disease Control (CDC) knew of these potential birth defects, as a 2011 study completed with grant money from the CDC reported that Zofran doubled the risks of birth defects, but the drug continued to be promoted to pregnant women. Dr. Gideon Koren’s study, published in the American Journal of Obstetrics and Gynecology, points out that about 1 million pregnant women are exposed to Zofran or its generic every year. This off-label use is at the heart of the current controversies and court battles: there is solid, public evidence that Zofran may be the cause of serious and potentially deadly side effects in babies. Side effects for mothers can include swelling, constipation, irregular heartbeat, dizziness, fainting, rashes, hives, and itching.
In 2012, the Center for National Birth Defects Research and Prevention found that the chances of developing a cleft lip and cleft palate increased 2.4 times when a mother took Zofran in the first trimester. Approximately, 9,000 pregnant women participated in the study.
In February 2013, the New England Journal of Medicine published a Danish study that reported that Zofran usage was not associated with increased malformation, i.e. birth defects. That very study was conducted on 608,835 pregnant women in Denmark between the years of 2004 and 2011. However, nearly six months after the initial study by Pasternak, a different analysis of that same data was conducted by another group of researchers who studied a larger pool of pregnant women (897,018 versus the initial 608,835) and a broader time range between 1997-2010. This second study of that same data found statistically significant risks associated with usage. More specifically, the second evaluation of that data showed a doubled risk of heart defects for babies whose mothers used Zofran, with an overall increased risk of defects about 30% among the 897,018 pregnant women studied. The fact that the same data yielded such varying results when conducted by different groups is quite startling.
The second study of that same data, conducted in August 2013, was not the only study demonstrating increased risk with Zofran usage.
Another significant health risk is the development of serotonin syndrome in expectant mothers. The syndrome can result when two or more prescription drugs affect the body’s natural serotonin levels simultaneously.
Serotonin, a neurotransmitter, is a natural chemical produced that allows brain cells and other nervous system cells to communicate with one another. It is a necessary chemical, but too little or too much can cause severe side effects. Too little contributes to depression and too many causes serotonin syndrome, a potentially life-threatening disease.
Zofran, in combination with a specific class of antidepressants known as serotonin reuptake inhibitors (SSRIs), can cause serotonin syndrome to occur. SSRIs are a type of drug that increases serotonin levels to prevent depression. If taken in conjunction with Zofran, a drug that also increases serotonin, the syndrome could occur. Symptoms of serotonin syndrome can include confusion, agitation, headache, changes in behavior, heavy sweating, and in extreme cases, seizures, irregular heartbeat, or unconsciousness. Don’t hesitate to reach out to TorHoerman Law if you have any SSRI lawsuit questions.
Anderka, Marlene, et al. “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects.” Birth Defects Research. Part A, Clinical and Molecular Teratology, U.S. National Library of Medicine, Jan. 2012, www.ncbi.nlm.nih.gov/pmc/articles/PMC3299087/.
“GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data.” The United States Department of Justice, 2 July 2012, www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report.
Koren, Gideon. “Treating Morning Sickness in the United States—Changes in Prescribing Are Needed.” American Journal of Obstetrics & Gynecology, vol. 211, no. 6, Dec. 2014, pp. 602–606., doi:http://dx.doi.org/10.1016/j.ajog.2014.08.017
Pasternak, B, et al. “Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes.” The New England Journal of Medicine., U.S. National Library of Medicine, 28 Feb. 2013, www.ncbi.nlm.nih.gov/pubmed/23445092
“What Is Serotonin Syndrome?” WebMD, WebMD, www.webmd.com/depression/guide/serotonin-syndrome-causes-symptoms-treatments#1.
“Zofran Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing.” WebMD, www.webmd.com/drugs/2/drug-30/zofran-oral/details.
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