Zofran, an unapproved drug commonly used for morning sickness, has been linked to case reports involving musculoskeletal birth defects. A recent study has also found that it doubles the risk of having a baby with cleft palate if taken during the first trimester.

Investigation Links Zofran and “Musculoskeletal Abnormalities”

July 2014 — An investigative report by the Toronto Star has identified 20 cases of birth defects associated with the use of Zofran during the first trimester of pregnancy — including one baby born with a “musculoskeletal abnormality.”

The investigators warned:

“So little is known about how ondansetron affects pregnant women that the drug manufacturer says such use is “not recommended” for these vulnerable patients.”

What are Musculoskeletal Defects?

As the name suggests, musculoskeletal birth defects affect the muscles and/or bones. There are a wide variety of malformations that can occur anywhere in the body, but most occur in the skull, face, spine, arms, legs, and feet. Treatment for musculoskeletal birth defects often involves complex surgery to reconstruct the affected body part.

Zofran and Cleft Palate

The most common musculoskeletal defect is cleft palate. All fetuses begin developing with a cleft palate, but the roof of the mouth normally fuses together around the 10th week of pregnancy. If it does not, the baby is born with a split that connects the mouth to the nasal cavity. Severe cases may involve the teeth, gums, and a cleft lip.

In January 2012, a study published in Birth Defects Research found a 2.4-fold increased rate of cleft palate in babies who were exposed to Zofran during the first trimester of pregnancy.


Many musculoskeletal defects affect the limbs, and one of the most common limb defects is clubfoot. This defect occurs when the muscles and bones of the leg, foot, and calf fail to develop, resulting in a foot that is sharply bent inward and downward at the ankle.

Treatment begins soon after birth, and typically involves physical therapy with bands to gradually stretch the foot into position, casts to immobilize the foot, and sometimes surgery.

Abdominal Wall Defects: Gastroschisis and Omphalocele

One of the most common abdominal defects is gastroschisis, a condition that occurs when there is a hole (“hernia”) near the base of the umbilical cord. This hole allows the infant’s intestines and sometimes organs (stomach, liver, bladder, etc.) to protrude outside of the body.

Omphalocele is a similar condition, but involves intestines and organs encased inside a membranous sac.

Limb Reduction Defects

A limb reduction defect occurs when muscles and/or bones in the arms or legs do not develop completely. The result is a limb that is shorter, smaller, or missing. Children who are born with limb defects may require assistance with daily activities, personal care, and need physical or occupational therapy.

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