Currently, Zofran, a 5-HT3 receptor antagonist, is only approved for use by cancer patients battling with nausea and vomiting after undergoing treatment. Yet, doctors routinely prescribed Zofran to pregnant women for off-label use for morning sickness. The medication, however, puts infants in the womb at a heightened risk of being born with birth defects, including musculoskeletal anomalies.
Musculoskeletal Anomalies Defined
Musculoskeletal birth defects are congenital deformities that develop in the infant’s muscles and/or bones. Infants of mothers who took Zofran while pregnant most often develop these abnormalities in the skull, spine, hips, and face, although it can occur in any part of the body.
There are numerous types of musculoskeletal birth defects, including:
Hand Birth Defects
In some instances, a baby is born with a missing hand, or hands that failed to form completely. For instance, some infants may be missing a finger or may have their fingers attached together. Infants with hand birth defects will usually require surgical procedures to correct the problem.
Facial Birth Defects
Facial birth defects, also known as orofacial defects, are the most common type of infant congenital abnormalities. Cleft palate and cleft lip, in particular, have been associated with pregnant women who used Zofran while pregnant.
For more information on cleft lip and cleft palate birth defects, refer to our article Craniofacial Birth Defects.
According to the Merck Manual, clubfoot is defined as defect that occurs when one foot or both feet are twisted outward from the normal position. Infants with clubfoot have a foot or feet typically have underdeveloped muscles in the calf or in the bones of the affected foot.
Per the American Academy of Orthopaedic Surgeons (AAOS), infant hip dysplasia, also referred to as “developmental dislocation of the hip” (DDH), occurs when the ball at the upper end of the femur (thigh bone) doesn’t join properly.
There are a few different types of DDH, including:
- Subluxatable: Subluxatable DDH is the most film form of the defect, marked by femur bone fitting loosely into the socket. The bone can still move, and is not dislocated.
- Dislocatable: Dislocatable DDH is marked by the head of the femur connecting in the right place, but can be dislocated with the wrong movements.
- Dislocated: Dislocated DDH is marked by the femur completely dislocated from the socket.
- Symptoms of DDH include one leg shorter than the other, uneven thigh skinfolds, limping, walking on toes, and/or exhibiting a “duck like” position by waddling.
Limb and Joint Birth Defects
Limb and joint birth defects occur when an infant is either missing an entire limb (such as an arm or leg) and/or is born with abnormally developed bones and joints. In addition, the fingers may not be the same size, or the toes may not grow properly.
How is Zofran Connected to Musculoskeletal Birth Defects?
The U.S. Food and Drug Administration (FDA) has approved the use of Zofran only for people with cancer who are undergoing chemotherapy and other treatments known to cause nausea.
However, GlaxoKlineSmith, the manufacturer of Zofran, saw a large market of pregnant women with morning sickness, and began promoting the drug to physicians, offering “kickbacks” if they prescribed the drug as off-label use to pregnant women with morning sickness.
In turn, many physicians all across North America began prescribing Zofran to pregnant women to help battle morning sickness. Yet, after infants were being born with birth defects, numerous studies were performed on Zofran, which indicate that women who take the medication while pregnant have a heightened risk of having babies with birth defects, including musculoskeletal birth defects.
What to Do if Your Baby Was Born With Musculoskeletal Birth Defects
If you were prescribed Zofran while pregnant and your baby was born with birth defects, it’s important to talk to an attorney to see what your rights are what you may be entitled to. An experienced Zofran lawyer can let you the qualifications needed for filing a claim against GlaxoKlineSmith, as well as if you have a legal case.
Caring for an infant with birth defects can be a lifelong expense, which includes medical appointments, treatment costs, and more. In some cases, babies may require multiple surgeries. The costs and expenses are usually more than the average family can afford.
However, by seeking damages against the manufacturer responsible for your baby’s health issues, you may be entitled to compensation for medical costs, lost wages, caregiver expenses, pain, suffering, and more.