Zofran Side Effects

Zofran Side Effects

Zofran is an oral prescription medication that is FDA-approved for the treatment of nausea and vomiting in surgery, chemotherapy, and radiation therapy patients. Doctors have prescribed Zofran as an off-label treatment for morning sickness, although its safety profile for pregnant women and their babies is undetermined. Zofran side effects range from mild to severe.

If you or a loved one suspect Zofran side effects may have caused a serious health issue, such as a birth defect in a child potentially exposed to the drug in utero, contact the experienced drug injury attorneys from The Sanders Firm to investigate.

Most common Zofran side effects

The most common side effects of Zofran are not serious in nature and include:

  • Headache
  • Fatigue
  • Diarrhea
  • Constipation
  • Dizziness
  • Wound healing problems
  • Drowsiness

FDA safety announcements

  • Abnormal heart rhythms (9/15/2011) – “Ondansetron may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.” As a result, the FDA mandated that the warning be added to the Zofran product label and safety materials.
  • QT prolongation (6/29/2012) – Following preliminary results from a clinical study, the FDA said ondansetron “may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.” The information was included on an updated safety label for Zofran.
  • Serotonin syndrome (9/19/2014) – 5-HT3 receptor drugs like Zofran, Aloxi, Kytril, and Zuplenz are under increased scrutiny as a potential risk factor for Serotonin Syndrome. Symptoms may include agitation, confusion, restlessness, sweating, shivering, muscle spasms, headache, diarrhea, and high blood pressure. Severe Serotonin Syndrome can lead to high fever, seizures, irregular heartbeat, and death. The FDA is “continuing to evaluate this issue to determine the need for any regulatory action.”

Does Zofran cause birth defects?

Several recent studies point to a possible link between Zofran and birth defects:

  • Cleft Palate – The odds of giving birth to a baby with Cleft Palate were doubled when mothers used ondansetron in the first trimester, according to data collected from the National Birth Defects Prevention Study in 2011 and a report titled “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects.”
  • Cardiac Malformations – Researchers observed a two-fold increased risk of cardiac malformations, according to “Ondansetron use in early pregnancy and the risk of congenital malformations,” a 2013 report published in the Int Soc Pharmacoepidemiology.
  • Overall Congenital Malformations – Researchers also found a 30% increased risk of any congenital malformation with ondansetron use during pregnancy in the 2013 paper cited above.

The Toronto Star claims to have uncovered the following Zofran side effects in the U.S. Food and Drug Administration’s public side-effect report database from 2012:

  • Two infant deaths
  • Multiple cases of newborns with heart defects and kidney malformations
  • Birth weights as low as 4.5 pounds
  • A musculoskeletal anomaly
  • A doctor’s suspicion that ondansetron caused mouth deformity, jaundice, heart murmur, and two heart defects

The safety of Zofran, particularly for pregnant women, is a matter of heated debate that is just starting to boil. The Sanders Firm will be monitoring any new developments closely, while continuing to investigate the facts surrounding our plaintiffs’ individual claims.

Zofran lawsuits

In 2012, Zofran manufacturer GlaxoSmithKline agreed to pay the U.S. Department of Justice $3 billion to resolve allegations that they promoted a number of their drugs for off-label purposes, including promoting “certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.”

A Pennsylvania woman filed a lawsuit against Zofran manufacturer GlaxoSmithKline in February 2014, alleging that both her children (born in 2004 and 2006) suffered heart defects as a direct result of the mother’s first trimester Zofran use. A similar lawsuit was filed by a Massachusetts woman in February 2015.

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Our personal injury law firm continues to make its industry-leading legal services even better, and hire attorneys and staff that enable us to serve a more diverse population.

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