Pregnant women who use the anti-nausea drug Zofran (generic: ondansetron) may be unknowingly exposing their babies to a risk of birth defects. One such defect linked to Zofran is intrauterine growth restriction (IUGR), which occurs when an unborn baby is significantly smaller than it should be because it is not growing at a normal rate in the womb.
Free Confidential Lawsuit Evaluation: If your child or other loved one was born with a intrauterine growth restriction after the mother took Zofran (ondansetron) while pregnant, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Zofran and our lawyers can help.
What’s the Problem?
Less than 10% of medications on the U.S. market have been studied well enough to determine their safety for use in pregnancy. However, 9 out of 10 women take at least one drug at some point during their pregnancy, and 7 out of 10 take at least one prescription drug.
Zofran (generic: ondansetron) is approved to treat nausea and vomiting associated with cancer treatment (radiation and chemotherapy) and certain types of surgery. The drug is classified as a Pregnancy Category B medication, which indicates that its effects on a fetus in the womb have not been well-studied.
However, according to an August 2014 analysis published in the American Journal of Obstetrics and Gynecology, around 1 million pregnant women are prescribed Zofran or generic versions each year to treat symptoms of morning sickness. Zofran is not and has never been approved for this purpose; however, doctors can prescribe medications “off-label” when they feel the potential benefits of a drug outweigh the risks.
Women who take Zofran during pregnancy may be increasing the risk that their babies will be born with birth defects. However, many doctors continue to prescribe the drug off-label to expecting mothers for the treatment of morning sickness, particularly during the 1st trimester, an infant’s most crucial development period.
Pharmaceutical companies and doctors have a legal obligation to warn patients of the risks associated with prescription drugs before prescribing them. In the case of Zofran, the danger may lie in the fact that the drug was not designed specifically for the treatment of nausea and vomiting in pregnant women. Yet doctors are still legally allowed to prescribe medications how they wish. Unfortunately, when prescribed off-label to expecting mothers, Zofran has been linked to severe congenital birth defects including intrauterine growth restriction (IUGR).
What is Intrauterine Growth Restriction (IUGR)?
Intrauterine growth restriction is typically defined as a fetal weight below the 10th percentile for gestational age. The defect may also be referred to as small-for-gestational age (SGA) or fetal growth restriction. There are 2 main types of IUGR:
- Symmetric or Primary IUGR – Characterized by a reduction in size of all internal organs. This form of the defect accounts for approximately 20% to 25% of all cases of IUGR.
- Asymmetric or Secondary IUGR – Head and brain are normal in size, but the abdomen is smaller. This form of IUGR is typically not observable until the 3rd trimester of pregnancy.
Signs and symptoms of intrauterine growth restriction may include:
- Low birth weight
- Difficulty handling delivery
- Decreased oxygen levels
- Low blood sugar (hypoglycemia)
- Low resistance to infection
- Low Apgar scores
- Trouble maintaining body temperature
- High red blood cell count
Even with recent advances in medical technology, effective treatment for intrauterine growth restriction remains problematic. Treatment options depend on how far the patient is along in her pregnancy.
If gestational age is 34 weeks or more, healthcare providers may recommend inducing an early delivery. If under 34 weeks, the fetus will be monitored for amniotic fluid levels and general well-being. If either of these becomes a problem, immediate delivery may be recommended. If delivery is advised before 34 weeks, an amniocentesis may be performed to help evaluate fetal lung maturity.
Do I Have a Zofran Intrauterine Growth Restriction Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran Lawsuits. We are handling individual litigation nationwide and currently accepting new intrauterine growth restriction cases in all 50 states.
Free Confidential Case Evaluation: Again, if your child or other loved one was born with a intrauterine growth restriction after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.