Does Zofran Cause Birth Defects?

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4075606281_ab1dc793c7_zAbout 3/4 of pregnant women suffer from morning sickness: nausea, vomiting, and headaches during the first part of pregnancy. No one likes feeling nauseated, so it’s only natural that we’d look for remedies for our discomfort. In some cases, doctors prescribe Zofran (ondansetron), an anti-nausea medication. However, evidence suggests that Zofran may be dangerous for the baby.

Zofran And Pregnancy

Morning sickness is a miserable part of pregnancy. Despite its name, it’s not limited to the morning. The nausea and vomiting can happen at any time of day or night and can be really tough to deal with. It’s not usually dangerous for you or the baby, but it’s certainly unpleasant.

Sometimes, natural remedies such as eating ginger, changing your diet, and getting regular exercise can help ease your upset tummy. Sometimes that’s not enough and you may want to seek out a more aggressive remedy to get you through the first part of your pregnancy. One popular remedy is Zofran (ondansetron), an anti-nausea drug. This drug was originally designed to ease the nausea of patients undergoing radiation and chemotherapy treatments for cancer.

Zofran is a very effective anti-nausea drug. However, Zofran and pregnancy aren’t necessarily a match made in heaven. It hasn’t been evaluated for safety in pregnant women and has been linked to an increased risk of serious birth defects.

What Causes Birth Defects?

A birth defect is medical condition that develops while the baby is in the womb. Some, such as Down Syndrome, are caused by genetic mutations. Others are caused by environmental factors separate from the baby’s genetics. These external causes are called “teratogens.” For example, alcohol can be a teratogen during pregnancy. Many medications can also act as teratogens during pregnancy.

Pregnancy severely limits the type of medications we can take. A lot of medication that is perfectly safe for adults can be very harmful for a developing fetus. Babies don’t have fully developed livers and kidneys, so their bodies can’t handle the same kinds of medications as we can. Instead, those drugs can cause serious damage to the baby.

Because of the ethical and safety concerns involved in testing medications during pregnancy, there are very few drugs that are FDA-approved for use in pregnant women. The fact that a drug isn’t FDA-approved for pregnancy doesn’t necessarily mean that it’s not safe, just that it has not been tested. However, doctors may choose to prescribe these drugs to pregnant women even without that approval. This is called an “off-label” use. For example, Zofran has not been approved for use in pregnant women but is frequently prescribed off-label to treat morning sickness. Now, evidence suggests that it isn’t safe for use in pregnancy.

Zofran And Birth Defects

Several studies have found links between Zofran and birth defects. A study of all Danish pregnancies between 1997 and 2010 found that babies who were exposed to ondansetron in the first trimester had an increased risk of serious heart defects. A similar Swedish study also found that ondansetron use increased the risk that the child would develop a heart defect. A US study also found an increased risk of cleft palates among children who had been exposed to Zofran.

Remember that even with Zofran, the risks of a birth defect are still quite low.

Zofran Lawsuits

The maker of Zofran, GlaxoSmithKline, has been sued many times over birth defects allegedly caused by Zofran, including heart defects, cleft palates, and kidney problems. In addition to the individual suits filed against the drug maker, GSK faced a major lawsuit over its branding and marketing of various drugs, including Zofran. The FDA carefully regulates how drug makers can market and sell their products and what sort of information they have to provide to doctors and patients. This large suit alleged that GSK was illegally marketing Zofran as an effective and safe treatment for morning sickness, which is an off-label use. It also alleged that GSK was paying doctors who prescribed the drug for off-label uses. In the end, GSK pled guilty and agreed to a $3 billion settlement.

If you took Zofran during pregnancy and your child suffered a birth defect, you may be entitled to compensation for the costs associated with your little one’s injury. You should speak with an experienced birth injury attorney to learn about your rights and options – those medical bills can add up quickly and you shouldn’t have to bear the cost when a pharmaceutical company hurts you or your family. The Safe Birth Project may be able to help, so contact us today to learn more.

How To Deal With Morning Sickness

Unfortunately, there are no surefire ways to deal with morning sickness without turning to medication. Some women have success with eating ginger, lemon, or mint. Others may find that eating many small meals is easier on their stomachs than eating fewer small meals. Exercise can also help settle your stomach, even if it’s just taking a long walk. The good news is that morning sickness typically ends with your first trimester, so you’ll only have to get through a couple of months.

If your morning sickness is very severe and is preventing you from getting enough to eat, contact your doctor to talk about whether you may have a more serious condition.

You should always work with your doctor to determine the right treatment plan for your unique needs and circumstances. In certain cases, you and your doctor may decide that the benefits of Zofran or other drugs may outweigh the potential risks. Zofran may increase the risk of birth defects, but that risk may be outweighed by other health concerns.

Did you find a good way to deal with morning sickness? Tell us about it in the comments!

 

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