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Zofran Use During Pregnancy Has Been Associated With Cleft Palate

Brian Finehout-Henry2 years ago

A study using data from the National Birth Defects Prevention Study found that use of ondansetron, the generic name for Zofran, during pregnancy doubled the risk of the baby being born with a cleft palate, according to a report from PediatricNews.

About Zofran

Ondansetron, which is sold under the brand name Zofran, was approved by the Food and Drug Administration, FDA, in 1991 for the prevention of nausea and vomiting following cancer treatments.

Zofran, manufactured by GlaxoSmithKline, works to treat nausea and vomiting by blocking a specific serotonin receptor, the 5-HT3 receptor, and is listed by the FDA as a pregnancy category B reports that category B drugs lack adequate human pregnancy safety data and that animal studies have not found any adverse effects.

Zofran use during pregnancy to treat morning sickness is “off-label,” this is the term used to describe the use a drug for a purpose not approved by the FDA.

In 2012 the United States Department of Justice announced that GlaxoSmithKline, also known as GSK, had pleaded guilty and paid a $3 billion fine to settle criminal and civil complaints that GSK had illegally marketed its prescription drugs for off-label uses.

A recent study found that during the 2000’s, the off-label use of ondansetron, the generic name for Zofran, during pregnancy increased by more than double and that by 2013, 1 million women per year took ondansetron during pregnancy.

Zofran Use During First Trimester of Pregnancy Linked to Birth Defects

A study conducted by scientists at the Sloane Epidemiology Center and the Centers for Disease Control and Prevention that found using ondansetron during pregnancy increased the risk of the fetus developing a cleft palate by 2.37 times.

This study used data from the National Birth Defects Prevention Study and assessed the risks for non-cardiac birth defects. Two other studies, looking at all birth defects, found that use of ondansetron, generic name for Zofran, during pregnancy increased the risks of a baby being born with a heart defect.

Nausea and vomiting of pregnancy, commonly called morning sickness, typically occurs early in the pregnancy, during the first trimester, and resolves as the pregnancy progresses, according to the American College of Obstetricians and Gynecologists.

Johns Hopkins Medicine reports that during the first trimester, which is the time when women may be prescribed Zofran for morning sickness, is when the fetus is the most vulnerable to developing birth defects.

Surgeries and Therapy Can Be Required to Treat Cleft Palate

The National Institutes of Health informs that cleft palates are birth defects affecting the roof of the mouth. The roof of the mouth forms between the 6th and 9th weeks of pregnancy and a cleft palate occurs when the two parts of the palate do not fuse together, according to the CDC.

The Mayo Clinic reports the following complications with cleft palates:

  • Trouble feeding
  • Reduced weight gain and development
  • Ear infections
  • Hearing loss
  • Dental Problems
  • Problems with speech

The Mayo Clinic reports many different treatments may be required in order to fix the cleft palate and the resulting complications:

  • Multiple surgeries to fix the cleft palate
  • Surgeries to improve cosmetic appearance
  • Surgery to place “tubes” in the ears to address ear infections
  • Hearing aids
  • Speech Pathology


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