Mothers And Babies Both At Risk Of Serious Zofran® Side Effects
Over 75 percent of expectant mothers experience nausea and vomiting during pregnancy, with some experiencing symptoms so severe they result in malnutrition and dehydration (called hyperemesis gravidarum), risking the health of both the mother and developing baby.
Zofran® and its generic ingredient ondansetron were prescribed to countless women to treat nausea and vomiting in the early months of pregnancy. However, the drug was never approved for morning sickness—it was actually approved for increasing appetite and curbing nausea after chemotherapy and surgery. Now doctors and researchers are concerned about the side effects of the drug in pregnant women, particularly after reports of birth injuries and other effects on the unborn baby.
Zofran Side Effects Include Injuries to Mothers and Babies
Many pregnant women have relied on anti-nausea medications to get them through the first few months of pregnancy, when nausea is at its peak. But this proved to be the most dangerous time for pregnant patients to take Zofran, as the first trimester is a crucial developmental stage for the fetus. A study published in 2012 examined over 10,000 pregnant women who suffered from morning sickness, discovering a twofold risk of birth defects in women taking ondansetron during the first trimester of pregnancy.
The most common side effects of taking Zofran during pregnancy include:
- Fetal growth restriction. Children may be born with an extremely low fetal weight (below the 10th percentile) after mothers have taken Zofran. This can include primary growth restriction, where all internal organs are reduced in size, or secondary growth restriction, where a baby’s abdomen is smaller than average but the head and brain are normal.
- Organ defects. Organ development takes place during the first trimester, and taking Zofran can inhibit the normal growth of a baby’s heart, brain, kidneys and liver. Liver damage can cause a yellowing or discoloration of the skin and whites of the eyes known as jaundice, while heart defects have included atrial and ventricular septal defects (holes in the heart).
- Foot abnormalities. Children may have difficulty walking or running due to abnormal development of their feet and legs. Newborns may suffer bowlegs, clubfoot, or feet that turn inward, causing physical disabilities and missed developmental milestones.
- Skull deformities. Zofran has been linked to a number of skull and mouth deformities in children, most notably cleft lip and cleft palate. The medication may also interrupt the proper development or fusion of the bones in the infant’s skull, resulting in cognitive problems or vision and hearing impairment.
- Infant mortality. Risks of spontaneous abortion and stillbirth are increased in pregnant patients, especially if the drug causes musculoskeletal abnormalities that the newborn cannot survive.
- Injuries to the mother. Many women taking Zofran have reported unpleasant or debilitating effects, including headaches, extreme dizziness, muscle spasm, and temporary loss of vision.
Zofran Fetal Injuries Often Require Costly Treatments
Many mothers have filed claims against drugmaker GlaxoSmithKline, claiming that they would never have taken the medication if they had been made aware of the risks to their children. Drugmaker GlaxoSmithKline has already pleaded guilty to federal charges of fraud for illegally promoting several of its medications, including Zofran. The settlement involved paying billions to families injured by these drugs, as well as an allegation that the company was aware of the risk to developing babies, but did not change its marketing to exclude pregnant women.