Zofran Birth Defects

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(odansetron hydrochloride) is approved for the treatment of nausea and vomiting caused by chemotherapy and radiation therapy in cancer and for the treatment of post-operative nausea.  It is available in tablet and solution forms for oral use and inject-able form for intravenous use.

Zofran is produced by GlaxoSmithKline (GSK), a large multi-national pharmaceutical company based in the UK.  In 2014, the company had estimated annual revenue of over $35 billion.

Zofran is the brand name for the generic medication, odansetron hydrochloride.  It is manufactured by the UK-based pharmaceutical giant, GlaxoSmithKline (GSK) which has operations in 115 countries and estimated annual revenue of $35 Billion.

Though it is approved for only cancer and surgery related nausea and vomiting, it has been used to treat nausea and vomiting in pregnancy.  This “off-label” use is allowed by the Food and Drug Administration if a physician feels that the drug is effective and safe enough, however the manufacturer is not allowed to promote or market the drug for unapproved uses.

GSK has settled claims of improper marketing of Zofran, including for use in pregnancy, with a payment of $3 billion.  The medication has caused a number of birth defects in women who used the medication while pregnant and has been shown to double the risk of certain congenital abnormalities including cleft lip and palate and congenital heart defects.

Birth Defects

Zofran is not approved to be used during pregnancy.  Despite this fact, many women have taken the medication for morning sickness or nausea and vomiting during pregnancy.

Nausea and vomiting most commonly occur during the first trimester or first 3 months of pregnancy.  Up to 15 percent of women experience nausea that is severe enough to require the use of medication.  The first trimester is also the period of time when a developing fetus is most vulnerable to damage caused by medication.  Zofran taken during pregnancy may have caused damage to the developing fetus, resulting in congenital malformation or birth defects.

Zofran Cleft Lip and Cleft Palate

In 2012, the Centers for Disease control concluded that Zofran taken during pregnancy may double the risk of development of cleft lip or palate.

Cleft lip or palate is a skeletal abnormality that may result from Zofran use during pregnancy.  Cleft lip and palate are caused by incomplete or improper development of the bones in the palate or roof of the mouth.  This may leave a hole in this portion of the skull, exposing the sinuses.  This may make it impossible for the child to nurse or eat and may leave the brain unprotected from infection.  Many children with cleft lip have an incomplete front jaw, lip, and nose, making it difficult to breathe properly.

Cleft lip or palate also results in significant facial disfigurement and will require surgery to correct.  Even with surgical correction, in many cases, the malformation cannot be completely repaired and the child may have permanent facial dis-figuration with continuing medical problems.  Other retrospective studies have also shown that Zofran may double the risk of cleft lip or palate.

Zofran Heart Defects

Zofran was shown in a 2013 study to double the risk of a congenital heart defect.  Birth defects caused by Zofran that may affect the heart include:

Atrial Septal Defect (ASD) – incomplete formation of the wall of tissue separating the two upper chambers (atria) from one another.  This “hole” in the heart may severely compromise proper circulation and must be repaired with surgery.  Surgery is sometimes but rarely conducted in utero (while the mother is still pregnant) or more often, shortly after the infant is born.  Some infants may require several surgeries performed over a period of months to years.  Until the condition is adequately repaired, the child’s development may be inhibited and in some cases may not be completely resolved and result in lifelong disability.

Ventral Septal Defect (VSD) – similar to ASD, but involving incomplete formation fo the wall between the two lower chambers of the heart or ventricles.  VSD is generally considered more serious and will also require surgical correction.  Many children with VSD may experience slow or inhibited physical and mental development.  Some children will have a lifelong disability due to congenital VSD.

Heart Murmur – heart murder is caused when the conduction system of the heart does not function properly.  It may result in inefficient circulation of the blood and may cause physical distress or an inability to perform physical activities.  It may also decrease effective blood and oxygen supply to the brain, limiting cognitive function.  Heart murmur may be mild to severe but is often not correctable by surgery and will be permanently disabling.

Multiple retrospective studies conducted in several countries, including the U.S. have shown that Zofran may increase the risk of other birth defects by as much as 34 percent.  Other potential birth defects caused by Zofran may include:

  • Kidney malformation
  • Skeletal defects
  • Fetal growth restriction
  • Spontaneous abortion
  • Stillbirth

Zofran Recall and Settlement

As early as 1999, GSK received warnings from the FDA regarding illegal marketing of Zofran including a failure to adequately warn of side effects.  The company was required to conduct a study of cardiac risks and subsequently recalled a high strength dosage of Zofran.   Following the results of that study, the FDA issued a warning about the risk of dosages over 16 mg in 2011.

In 2012, Glaxo settled allegations by the Department of Justice that they had illegally promoted Zofran for use during pregnancy and that they had paid physicians to use Zofran in their practices.  Thee company paid $3 billion in civil and criminal penalties as a result of those allegations, however this payment does not release GSK from liability for children who may have been harmed by perinatal use (use during pregnancy) of Zofran.

Any child who suffered birth defects may be eligible for damages caused by Zofran if taken during pregnancy.  The family of a child who was injured or died as a result of Zofran use may also be entitled to damages.  Actual damages include reimbursement for medical costs, loss of work and pain and suffering.  Some patients may also be eligible for punitive damages when it can be shown that the company knew of risks of medication but continued to allow its use or did not provide adequate warning regarding the risks.

Other Zofran Side Effects

All medications have a number of side effects, including Zofran.  In most cases, the side effects are mild to moderate and may go away after a period of time.  Other side effects can be more severe and may cause permanent injury or even death.

Mild side effects of Zofran include rash, redness and itching of the skin, along with constipation with continued use.

Zofran may also cause changes in the heart rhythm.  These changes may cause symptoms such as irregular heartbeat or palpitations, dizziness or fainting, shortness of breath or difficulty breathing and swelling, particularly in the abdomen and lower legs.

These heart symptoms are caused by a condition known as QT prolongation.  In some susceptible patients, QT prolongation may cause Torsades de Pointe, a serious and sometimes fatal heart abnormality.  Any cardiac symptoms should be reported to a physician immediately and the FDA has warned that patients with certain cardiac conditions should not take Zofran.

View Sources

  1. Anderka, M., et al, (19 November 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, Accessed on 12 February 2015 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3299087/
  2. Andersen, JT, et al, Ondansetron use in early pregnancy and the risk of congenital malformations, Department of Pharmacology, Bispebjerg Hospital, Accessed on 12 February 2015 http://clin.au.dk/fileadmin/www.ki.au.dk/forskning/forskningsenheder/gyn__kologisk-obstetrisk_afd__y/logistics/sandbjerg_m__der/sandbjerg_2012_Obstetrisk_Sandbjerg-moede_2012/Sandbjerg_2013/130227_Ondansetron_use_in_early_pregnancy_and_the_risk_of_congenital_malformations.pdf
  3. Barnato, K., (04 February 2015), GSK revenue falls, but firm upbeat on respiratory business, CNBC.com, Accessed on 12 February 2015 http://www.cnbc.com/id/102395839
  4. Centers for Disease Control, (2015), Facts about cleft lip and palate, CDC, Accessed on 12 February 2015 http://www.cdc.gov/ncbddd/birthdefects/CleftLip.html
  5. Department of Justice, (02 July 2012), GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data, U.S. Department of Justice, Accessed on 12 February 2015 http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report
  6. Food and Drug Administration, (15 September 2012), FDA Drug Safety Communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron), U. S. Food and Drug Administration, Accessed on 12 February 2015 http://www.fda.gov/Drugs/DrugSafety/ucm271913.htm
  7. Food and Drug Administration, (29 June 2012), FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran), U. S. Food and Drug Administration, Accessed on 12 February 2015 http://www.fda.gov/Drugs/DrugSafety/ucm310190.htm
  8. Food and Drug Administration, (04 December 2012), FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products, U. S. Food and Drug Administration, Accessed on 12 February 2015 http://www.fda.gov/Drugs/DrugSafety/ucm330049.htm
  9. GSK, (2015), Zofran Injection Prescribing Information, GlaxoSmithKline, Accessed on 12 February 2015 https://www.gsksource.com/gskprm/htdocs/documents/ZOFRAN-INJECTION.PDF
  10. GSK, (2015), Zofran Oral Prescribing Information, GlaxoSmithKline, Accessed on 12 February 2015 https://www.gsksource.com/gskprm/htdocs/documents/ZOFRAN-ORAL.PDF
  11. GSK, (2015), About Us, GlaxoSmithKline, Accessed on 12 February 2015 http://www.gsk.com/en-gb/about-us/McLean, J., et al, (25 June 2014), Birth defects blamed on unapproved morning sickness treatment, thestar.com GTA, Accessed on 12 February 2015 http://www.thestar.com/news/gta/2014/06/25/birth_defects_blamed_on_unapproved_morning_sickness_treatment.html
  12. Mayo Clinic, (2015), Types of Congenital Heart Defects, mayoclinic.org, Accessed on 12 February 2015 http://www.mayoclinic.org/diseases-conditions/congenital-heart-defects/multimedia/congenital-heart-defects/sls-20076059
  13. SOGC, (2015), Nausea and Vomiting During Pregnancy, The Society of Obstetricians and Gynaecologists of Canada (SOGC), Accessed on 12 February 2015 http://sogc.org/publications/nausea-and-vomiting-during-pregnancy/
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