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Medical Law -- Pate & Spivey, LLP

Pharmaceutical and Medical Device Litigation

Zofran (Ondansetron): During Pregnancy Linked to Heart Defects, Oral Facial Clefts & Other Congnital Malformations.

Zofran During Pregnancy

Parents of children with heart abnormalities, cleft palates and other birth defects should know that Zofran has been linked with these defects.  The Federal Food and Drug Administration has warned that the use of Zofran could result in potentially fatal abnormal heart rhythm.  In addition, studies indicate that use of Zofran during pregnancy may also be linked to orofacial clefts and other congenital malformations.

Zofran Manufacturers Failed to Warn of Zofran Link to Birth Defects

The drug Zofran (known as Ondansetron) is used to control nausea and vomiting in patients who undergo chemotherapy, radiation, or surgical proceedures.  However, the drug has been prescribed during pregnancy to reduce the symptoms of morning sickness, despite the fact that the FDA has not approved Zofran for this purpose.

"Hole in the Heart," Abnormal Heart Rhythm, Cleft Palate, Cleft Lip

The use of Zofran in the first trimester of pregnancy was reportedly linked to a doubled risk of “hole in the heart” defects and a 62% increased risk of heart defects overall, according to a study published by the medical journal Reproductive Toxicology in December 2014.  Symptoms may include heart murmur (abnormal sound a doctor hears using a stethoscope), fast and hard breathing, shortness of breath with activity, paleness, failure to gain weight or thrive,  sweating while feeding, and frequent respiratory infections in children.  Babies with a “hole in the heart” may suffer from low oxygen levels in their bloodstream, which can cause weakness, poor feeding, and failure to thrive.  The defect often forces more blood into the lungs, causing pulmonary hypertension. High blood pressure damages delicate blood vessels in the lungs, permanently damaging tissue. The condition also forces the heart to work harder than normal, which causes it to enlarge and lose flexibility. Left untreated, this can lead to heart failure and death.

Research suggests that use of Zofran for morning sickness may increase the risk that children will experience cleft palate malformations by a ratio of 2.37 to 1. This has also led to concerns within the medical community of a link between Zofran and cleft lip defects. Cleft lip and cleft palate malformations, together referred to as oral clefts, occur early in pregnancy and result in not enough tissue in the mouth or lip for them to merge and form properly. In cleft lip malformations, this manifests as a physical split in the upper lip. In cleft palate malformations it results in a whole or split in the roof of the mouth. Oral cleft defects can cause problems with talking, eating, and can increase the risk of ear infections and other health problems. Children born with a Zofran cleft palate or lip can experience feeding problems and other issues that have the potential to negatively impact their health and well-being. As such, they must endure reconstructive surgery (sometimes multiple procedures) at a very young age to correct the condition.

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