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Zofran Side Effects and Birth Defects

baby reaching for father's fingerAn estimated 10 to 15 percent of all pregnant women suffer morning sickness that calls for prescription medication for relief. Some cases are so severe that they require hospitalization for uncontrolled vomiting, severe dehydration, and significant weight loss. This condition, known as hypermesis gravidarum, or extreme morning sickness, affects about 1% of all pregnancies.

The law firm of Eisbrouch & Marsh notes that, as one mother put it, “When you’re in that state, you can’t sleep, you can’t eat, you can’t drink, you just physically can’t do anything. You know it’s not sustainable for you or your baby. You have to take something.” For some of those women, it’s a decision they will regret.

Zofran is a serotonin-3 (5-HT3) receptor antagonist that reduces nausea and vomiting by blocking serotonin and inducing gastric emptying. Well before the FDA approved Zofran for use as an anti-nausea drug specifically for use in cancer patients undergoing chemotherapy and radiation therapies, its researchers had been seeking other medical applications where a powerful anti-nausea drug might be effective. Today, Zofran is commonly used by cancer patients and pregnant mothers experiencing morning sickness.

Researchers study Zofran & birth defects

In 1991, the drug maker GlaxoSmithKline, received FDA approval for its anti-nausea drug ondansentron hydrochloride, known more commonly by its brand name Zofran, to be used for chemo and radiation therapy patients. However, GlaxoSmithKline soon began marketing Zofran as an off label morning sickness treatment despite the fact that its effects had not been studied in pregnant women. The results have been catastrophic, according to those who have taken legal action.

Though early studies and a general lack of available reproductive safety data served as reassurance that the medication was harmless, recent data has sparked some controversy.

In 2011, the NCBI published observed data under the title “Medications Used to Treat Nausea and Vomitting of Pregnancy and the Risk of Selected Birth Defects.” Though morning sickness was not found to be associated with an increase of birth defects by  itself, the “chance findings” of treating the symptoms with ondanestron (generic Zofran) did “warrant further investigation” according to data analysis.

Further analysis was performed and published in the New England Journal of Medicine, February 2013. Though scientists concluded that the medication did not cause fetal harm, skeptics noted that half of the 2,000 women studied began taking the medication after they had cleared the 10 week window when birth defects normally develop. And so researchers continued to analyze even more data.

Later in 2013 a group of Danish medical researchers released the most comprehensive analysis of the link between Zofran and birth defects to date. From among 900,000 pregnancies listed in national registries between 1997 and 2010, they discovered that 1,248 women filled a prescription for odensetron during their first trimester. Of those women, 4.7% delivered a baby with a congenital birth defects. According to their analysis, researchers concluded a 30% increased risk.

Victims need an advocate

The product liability lawyers of Eisbrouch Marsh stand ready to protect the rights of women who were prescribed Zofran to treat morning sickness. Mother and babies born with birth defects are paying dearly by exposing their unborn children to the effects of this medication without knowing the full scope of the risk. Eisbrouch Marsh has staked its reputation on being a tireless advocate for victims of dangerous drugs who seek  justice and compensation after suffering serious side effects and resulting complications.

  1. OBGYN News - Ondansetron: New and troubling data http://www.obgynnews.com/index.php?id=11370&type=98&tx_ttnews[tt_news]=221089&cHash=da03e20e36
  2. Toronto Star - Birth defects blamed on unapproved morning sickness treatment http://www.thestar.com/news/gta/2014/06/25/birth_defects_blamed_on_unapproved_morning_sickness_treatment.html
  3. NCBI, Medications Used to Treat Nausea and Vomiting of Pregnancy  and the Risk of Selected Birth Defects  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3299087/
  4. FDA – Ondansetron Drug Safety Information http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm271924.htm