Birth Defects which may be linked to Zofran®

Heart/Septal Wall Defects that may to be linked to Zofran® use during pregnancy include Heart Murmur, Atrial Septal Defect (ASD) and Ventricular Septal Defect (VSD). ASD and VSD are sometimes called “Hole in the Heart”. Heart Murmur is an unexpected sound in a heartbeat. The sound doctors hear through a stethoscope in a healthy heart are the sounds of the valves in your heart closing like they should. A Heart Murmur is an extra sound produced during the heartbeat that can be a sign of congenital heart defect. ASD and VSD are both defects, or holes, between the walls separating the chambers of the heart. In ASD, the hole is between the left and right Atrial (upper) chambers of the heart, while in VSD, the hole is between the left and right Ventricle (lower) chambers of the heart. Both defects cause blood to flow abnormally between the chambers of the heart. Heart Murmur, ASD and VSD can lead to other serious health problems like enlarged heart and lung disease.

Cleft Palate deformity is a deformity in the roof of the mouth (palate) and may be linked to Zofran® use during pregnancy. It occurs when the tissue that forms the roof of the mouth fails to completely join together during the first trimester of pregnancy. Cleft Palate defects can occur with only part of the palate not being joined together, or all of the palate not being joined together. Cleft Palate can lead to feeding and speech problems, as well as increased ear infections and dental problems. Surgery to repair Cleft Palate is recommended within the first 18 months of a child’s life. Cleft Palate oftentimes is seen in babies who also have Cleft Lip.

Cleft Lip deformity is similar to Cleft Palate in that the tissue of the lip does not properly join together during early pregnancy. Cleft Lip defects, which may be linked to Zofran® use during pregnancy, can lead to feeding and speech problems. Surgical repair of Cleft Lip is typically performed as soon as possible during infancy.

Club Foot, a birth defect that may be linked to Zofran® use during pregnancy, is a musculo-skeletal defect of the foot in which a baby’s foot is positioned at an improper angle, making the leg and foot resemble a golf club in appearance. Orthopedic intervention is needed early in infancy, however non-surgical methods such as casting and bracing can usually correct this problem.

Musculo-Skeletal Defects refers to a large group of abnormalities including defects to the hands, feet and limbs. Musculo-Skeletal Defects may be linked to use of Zofran® during pregnancy and include: Under-development and Over-development of bone; Radial and Ulnar Club Hand which involves underdeveloped or missing bones in the hands and wrists; and, Syndactyly of the fingers or toes, also known as “webbed” fingers or toes. Many Musculo-Skeletal Defects require surgical intervention in early infancy. Some can be treated with non-surgical methods like stretching and splinting.

Craniosynostosis, a serious birth defect that may be linked to Zofran® use during pregnancy, results in the skull plates in the head fusing fully together too soon in the course of the baby’s development. This results in the head being too small for the brain to properly develop in the limited space. Children with Craniosynostosis usually require surgery. The premature fusion of the skull plates can lead to the child having a misshaped head and facial features. It can also lead to problems in development of the brain causing developmental delays and learning difficulties.

Neural Tube Defects are permanent, un-curable defects of the brain or spinal cord that may be linked to Zofran® use during pregnancy. Neural Tube Defects usually result in at least some paralysis or loss of sensation, including incontinence; and, learning or developmental delays. Neural Tube Defects include conditions such as Hydrocephalus, an accumulation of fluid in the brain; Spina Bifida, the incomplete formation of vertebrae which results in at least some to full protrusion of the spinal cord in the most severe cases; Chiari Malformation, in which brain tissue grows down into the spinal column; and, Anencephaly, the failure of the skull and brain to fully develop. Anencephaly results in death shortly after live birth or in stillbirth.

Kidney Defects that may be linked to use of Zofran® during pregnancy include the malformation or under-development of one or both kidneys, including conditions such as in Renal Agenesis, Potter’s Syndrome, and Renal Dysplasia. Urinary Defects may also occur including Hypospadias (in boys), where the urinary opening (urethra) is located somewhere other than on the head of the penis; and other urinary tract obstructions that can lead to Hydronephrosis, an accumulation of urine in the kidneys, or Vesicouretal Reflux which occurs when the valve that stops urine from flowing back up to the kidneys does not function properly

Gerald Schwartz is a Pharmacist-Attorney who understands Zofran® -- its chemistry, its biology and how it affects pregnant women. If your baby was born with a birth defect, contact Gerald Schwartz for a free consultation to learn your rights. 1-800-423-0055

** If you are presently taking Zofran® for morning sickness, consult your doctor before stopping or starting any medications. Zofran® is a registered trademark of GlaxoSmithKline.