Study Suggests Zofran Not Safe for Use During Pregnancy
Many pregnant women are prescribed Zofran as an anti-nausea drug. Yet a recent study published in the American Journal of Obstetrics and Gynecology suggests that this drug, if taken during pregnancy, could cause serious injuries to the fetus. The study indicates that use of the prescription medication during pregnancy may in fact result in serious birth defects.
The lead researcher, Dr. Gideon Koren, is the founder and director of the Motherisk Program, as well as a professor of pediatrics, pharmacology, pharmacy, and medicine at the University of Toronto, Ontario. He also serves as a staff physician at the Hospital for Sick Children in Toronto. How did Koren’s study reach its conclusion?
Koren and his team studied 900,000 women and discovered a twofold “increased risk of cardiac malformations” when pregnant women used Zofran. The use of Zofran (also known by its generic name ondansetron) led to “an overall 30 percent increased risk of major congenital malformations.” During pregnancy, many women suffer from nausea and vomiting of pregnancy (NVP), more commonly known as “morning sickness.” When women visit their obstetricians and complain of these symptoms, many physicians will prescribe anti-nausea drugs.
Koren’s team compared Zofran (and its generic version) to metoclopramide in determining the risk of birth defects from anti-nausea drugs. Metoclopramide is another anti-nausea medication frequently used by pregnant women suffering from NVP. The study’s results suggested that pregnant women should be looking to different anti-nausea medications other than Zofran, given the risk of birth defects.
What drugs can women safely take while pregnant? Some physicians recommend over-the-counter usage of vitamin B6, while others recommend FDA-approved treatments like pyridoxine or doxylamine. According to Koren, “there is no reason for women to be exposed to a drug of unproven maternal and fetal safety” if they have access to other NVP remedies.
Facts About Medicine and Pregnancy
Taking medications while you are pregnant can pose dangers to the fetus. The Centers for Disease Control and Prevention provides a factsheet about medication risks for women who are pregnant or who are thinking about becoming pregnant.
Generally speaking, the CDC reports that fewer than 10 percent of prescription drugs that have FDA approval have been assessed for pregnancy-related risks. The following two medications are known to cause birth defects:
- Thalidomide (which goes by the brand name Thalomid); and
- Isotretinoin (or, Accutane).
Other medications, too, may pose a serious risk to the health of a fetus.
According to the CDC, numerous factors are involved in assessing the risk of taking certain prescription drugs while pregnant, such as:
- The amount or dose of the medication;
- At what stage in your pregnancy you took the medication;
- Other medications you took during pregnancy; and
- Other health issues you may have.
One of the most important things to remember is that you should not believe everything you are hear. If you find information about drugs that are “safe” for use during pregnancy, you should always speak with your doctor before using any medications and research all of the possible side effects. Moreover, if you have been exposed to a drug or another substance that is known to cause birth defects, you should contact your healthcare provider as soon as possible.
If your child was born with a serious birth defect as a result of a medication you took during pregnancy, you may be able to file a claim for financial compensation. Contact a birth defect lawyer today to discuss your case.