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Was your child born with birth defects after you used Zofran or Zuplenz?You might be entitled to compensation.

Doses and Formulations

Zofran is available in injections and oral forms. Zuplenz is available in an oral form.

Zofran Injection, 2mg/L (approved 1991)
Zofran Tablets, 4 mg and 8 mg (approved 1992)
Zofran Premixed Injection, 32 mg (approved 1995)
Zofran Oral Solution, 4mg/5mL (approved 1997)
Zofran Orally Disintegrating Tablets 4mg, 8mg (approved 1999)
Zuplenz Orally Dissolving Tablet, 4mg, 8mg (approved 2010)

Serious Birth Defects

Zofran, Zuplenz and the generic version ondansetron are labeled as Pregnancy Risk Category B, meaning there is no evidence of risk to humans. Many mothers took this assurance to mean the drug was safe, but multiple studies show evidence to the contrary. Because Glaxo never proved Zofran was safe, the FDA never gave an approval to market the drug to pregnant women. Regardless, Glaxo continued to advertise its anti-emetic for morning sickness.

Some mothers found out too late about the dangers of the drug. In studies and lawsuits filed by mothers and families of injured babies, a number of side effects are linked to the medication, including:

worried pregnant woman sitting down with hand over her mouth
Birth Defects Linked to Zofran
Mental problems Physical deformities Hearing Loss
Vision problems Heart defects Abnormal blood pressure
Stomach problems Cleft lip Cleft palate
Club foot Webbed toes Skull deformities

Case Studies Show Pregnancy Risk

In December 2014, Dr. Gideon Koren published the findings of his Zofran study review in the American Journal of Obstetrics and Gynecology. Among the results he presented was a 2013 study of 900,000 Danish women that found a "2-fold increased risk of cardiac malformations with ondansetron (including Zofran and Zuplenz), leading to an overall 30 percent increased risk of major congenital malformations."

Before this, in 2011 a large control study by the Slone Epidemiology Center in Boston, Mass, and the Centers for Disease Control and Prevention revealed a 2-fold increase in the risk of cleft palate defects when women took Zofran and other versions of the drug during the first trimester.

According to court documents, Glaxo's own clinical data in animal studies from its early applications for Zofran FDA approval in the 1980's showed "clinical signs of toxicity, premature births, intrauterine fetal deaths, and impairment of ossification (incomplete bone growth)." Some of the animals also showed evidence of congenital heart defects and developmental retardation.

The drug can also cross the placental barrier and be excreted in breast milk. In tests, fetal tissue samples showed about 41 percent of the concentration of Zofran in the mother's blood – according to court documents, this is enough to cause fetal malformations.

Serious Side Effects

In addition to birth defects, Zofran and other versions of the drug have a list of other side effects, some of which are serious, including Serotonin Syndrome and QT Syndrome.

Serotonin Syndrome

This occurs when too much serotonin is present in the body. This is a serious condition that can be life-threatening. Symptoms include high fever, irregular heartbeat, seizures and unconsciousness.

QT Syndrome

Zofran can affect the electricity in the heart, causing erratic heartbeats that can be fatal.

Other serious side effects include:
Blurry vision Shortness of breath
Confusion Excessive sweating
Seizures Coma
Loss of consciousness Chest pain
Hives or rash Swelling
More common side effects are:
Headache Constipation
Weakness Tiredness
Chills Drowsiness
Diarrhea

Drug Interactions

Certain drugs may increase the risk of serious side effects when used with Zofran, Zuplenz or generic ondansetron. These drugs include:

Apomorphine

Phenytoin, Carbamazepine, and Rifampin

Tramadol

SSRIs like Paxil and Zoloft

SNRIs like Cymbalta and Pristiq

Zofran Recall

In 2012, the FDA issued a recall for the 32 mg intravenous dose of Zofran because of the "potential for cardiac risks." The oral versions of the drug were not affected. The abnormal rhythm disorder is called QT interval prolongation and can lead to Torsades de Pointes an abnormal, potentially fatal heart rhythm.

Additional Resources for Pregnant Women

Women who are pregnant or who plan on becoming pregnant should be extremely cautious with the drugs they take. Prescription medications and over-the-counter drugs can affect the development of a fetus and affect a pregnant woman differently than a woman who is not pregnant.

  • Drugwatch provides a vast amount of information on women’s health and pregnancy, including which drugs may be dangerous to take during pregnancy.
  • Women experiencing morning sickness should have in-depth talks with their health care providers about treatments for morning sickness and possible side effects.
  • Researching drugs online can also help women make informed decisions. The Centers for Disease Control and Prevention and the U.S. National Library of Medicine provide vast amounts of information online about pregnancy and medications.

Additional Treatment Options

It is very common for pregnant women to experience morning sickness during the first trimester. Some home remedies for treating morning sickness include eating light snacks throughout the day or sipping ginger ale to relieve nausea. It’s also highly recommended that all pregnant women stay hydrated and take prenatal vitamins for nutritional needs.

Women who experience hyperemesis gravidarum, or NVP, may require hospitalization and intravenous (IV) fluids. In some cases, a doctor may prescribe vitamin B-6 supplements, antihistamines or other anti-nausea drugs. Women should ask their doctor about all potential side effects of an anti-nausea drug and ask if it is FDA approved for use in pregnant women before agreeing to the treatment.

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  1. Anderka, M., et al. (2012). 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. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3299087/
  2. Koren, G. (2014, December). Treating morning sickness in the United States—changes in prescribing are needed. American Journal of Obstetrics & Gynecology. Retrieved from http://www.ajog.org/article/S0002-9378(14)00853-9/fulltext
  3. Koren, G. (2013, October 25). Ondansetron: New and troubling data. Ob.Gyn.News. Retrieved from http://www.obgynnews.com/views/drugs-pregnancy-and-lactation/blog/ondansetron-new-and-troubling-data/00595b8bf7a0ec96a0d280e28af9edd6.html
  4. LeClair v. GlaxoSmithKline. (2015, February 16). United States District Court of the District of Massachusetts. Complaint and Jury Demand. Case No. 1:15-cv-10429.
  5. National Institutes of Health. (2015). Ondansetron. Retrieved from http://www.nlm.nih.gov/medlineplus/druginfo/meds/a601209.html
  6. Strativa Pharmaceuticals. (2010, July 2). FDA approves Strativa Pharmaceuticals' Zuplenz (ondansetron) oral soluble film [Press release]. Retrieved from: http://www.prnewswire.com/news-releases/fda-approves-strativa-pharmaceuticals-zuplenz-ondansetron-oral-soluble-film-97696804.html
  7. U.S. Food and Drug Administration. (2012, December 4). Ondansetron (Zofran) 32 mg, Single Intravenous (IV) Dose: Updated Safety Communication – Product Removal due to Potential For Serious Cardiac Risks. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm330772.htm
  8. U.S. National Library of Medicine. (2014). Zofran – ondansetron hydrochloride injection. Daily Med. Retrieved from http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d9a71b42-ddfc-49d5-7280-0fc0041dba41&#section-1
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