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Zofran Use During Pregnancy Linked to Cleft Palate

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Brian Finehout-Henry2 years ago

Pediatric News reports that a study from the Center for Birth Defects Research and Prevention found that ondansetron, Zofran’s generic name, used during pregnancy doubled the risk of the baby having a cleft palate.

Zofran and Off-Label Marketing

Zofran, developed by GlaxoSmithKline and approved for the market in 1991, is an antiemetic and comes in several forms: injection, tablet, oral solution, and orally dissolving tablet.

The Food and Drug Administration has approved Zofran to be used in treating nausea and vomiting that arises from cancer treatment or occurs after surgery and anesthesia.

In 2012, GlaxoSmithKline pleaded guilty and paid $3 billion to settle charges that the company illegally marketed drugs, withheld safety information, and other allegations, according to an United States Department of Justice announcement.

The Toronto Star reports that the government alleged GlaxoSmithKline; illegally promoted Zofran for use in treating morning sickness, paid doctors kickbacks when they prescribed Zofran for morning sickness, and distributed false information about Zofran’s safety and effectiveness.

Study Finds Zofran Doubles the Risk of Cleft Palate

An article in Therapeutic Drug Monitoring reports that the study conducted by the Slone Epidemiology Center and the Centers for Disease Control and Prevention found that ondansetron, when used in the first trimester of pregnancy, more than doubled the risk of the baby being born with a cleft palate.

The study authors used data from the National Birth Defects Prevention Study of over twenty thousand women to determine the risk of non-cardiac birth defects associated with medications given for morning sickness. The authors found that ondansetron, which is the generic name for Zofran, increased the risk of cleft palate by 2.37 times when given during the first trimester of pregnancy, which is when the baby is susceptible to chemicals causing birth defects.

OBGYN News reports that another study of Zofran and birth defects using Swedish medical records found that ondansetron significantly increased the risks for heart defects. Another study using Danish records, found that ondansetron, when used during pregnancy, doubled the risk of cardiac defects, according to Mother Risk.

Cleft Palates Can Require Extensive Treatment to Repair

The Centers for Disease Control and Prevention explains that cleft palates occurs when the tissues, which make up the roof of the mouth, fail to grow together; a process that is completed during the first trimester of pregnancy. The National Institutes of Health reports that babies with cleft palates can face many complications:

  • Feeding problems
  • Poor growth
  • Failure to gain weight
  • Ear infections
  • Dental problems
  • Speech difficulties
  • Hearing problems and loss

According to the Mayo Clinic, infants and children with cleft palates need extensive treatment from a coordinated team of medical professionals, which can involve:

  • Surgery to repair the cleft palate within the first eighteen months
  • Follow up surgeries as the child ages and grows
  • Surgery to place tubes in the ears
  • Hearing aids and hearing therapy
  • Speech therapy
  • Prosthetic devices to close cleft and allow for better feeding prior to surgery
  • Special dental and orthodontist appointments
  • Psychological care


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