Zofran Side Effects - Birth Defects Risk, Heart Defects
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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

Drug label warnings

More serious side effects have shown up in clinical studies and the FDA’s adverse event reporting database.

According to the Zofran drug label, these side effects include:

  • Drug interactions: There have been reports of “profound hypotension and loss of consciousness” when ondansetron is given along with apomorphine. Other drug interactions include: Phenytoin, Carbamazepine, Cisplatin, and Rifampicin. Patients on tricyclic or serotonin reuptake inhibitor anti-depressants should avoid Zofran due to concerns about Serotonin Syndrome that include muscle spasms, delirium, coma, and death.
  • Hypersensitivity: Some patients exhibit a hypersensitivity to 5-HT3 receptor antagonists and suffer shortness of breath, edema, ECG changes, low thyroid functioning (“QT interval prolongation”), and Torsade de Pointes (a potentially fatal heart condition).
  • Masking health problems: Gastric distension may be masked in surgical and chemotherapy patients taking ondansetron.

Close monitoring is recommended for patients with:

  • Hypokalemia or hypomagnesemia
  • Congestive heart failure
  • Bradyarrhthmias
  • Prescriptions that cause QT prolongation

Zofran is labeled as “Pregnancy Category B,” which means that animal studies show no risks, but there have been “no adequate and well-controlled studies” that demonstrate safety in pregnant women. The label goes on to say that the drug should “be used during pregnancy only if clearly needed.”

Ondansetron was found in the breast milk of rats, but it is “not known whether ondansetron is exreted in human milk,” according to product labeling, so caution is urged for the drug’s use in nursing women.

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 musuloskeletal 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.

Do you worry Zofran side effects may have hurt your family?

It is terrible to think a drug a patient has voluntarily ingested to treat vomiting and nausea may have caused harm. The Sanders Firm understands the heartache your family has suffered. Having an experienced legal team working on your case provides added peace of mind that all details of your claim will be thoroughly investigated to see if there are legal grounds for compensation. Call 888.743.1031 to speak with an experienced product liability attorney.