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For starters, congratulations! You’re probably focused on the joy of a new baby on the way (as you should be). But, you may also find yourself struggling with a major downside: morning sickness.
It’s estimated that 70-80% of pregnant women deal with nausea and vomiting at some point during their pregnancy.
When you’re dealing with severe nausea and vomiting, a drug called Zofran® may be prescribed to help. But if you’re pregnant, you have every right to be extra careful about what you put in your body.
This can lead to a big question on your mind: “Is Zofran® safe for pregnancy?”
The answer isn’t as simple as we might like it to be. Recent studies have been done on the safety of taking Zofran® during pregnancy. But their results have been mixed.
We’re here to help you get the facts. Let’s dig into what the research says about taking ondansetron (the generic name for Zofran®). We’ll also look at what you should know to make the best decision for you and your baby.
Key Takeaways
- Nausea and vomiting are very common in pregnancy
- Zofran® is a drug that can help treat nausea and vomiting. But its use for pregnancy is considered off-label by the FDA.
- Recent studies on whether Zofran® is safe for pregnancy have been conflicting. Some suggest a low overall risk. And other studies have linked it to a slightly higher risk of heart defects and cleft palate.
- The risk appears to be higher with use in the first trimester of pregnancy. So, many physicians are cautious during this time.
- The only FDA-approved drug for morning sickness is Diclegis. But other options exist, including non-drug methods.
- You and your healthcare provider should talk about your individual symptoms and health to decide the best treatment for you.
What Is Zofran® and Why Is It Used?
Zofran® is the brand name for a drug called ondasetron. Ondansetron is a drug used for treating nausea and vomiting following surgery, chemotherapy, and radiation therapy.
This drug has also been prescribed during pregnancy to help with morning sickness symptoms. Doctors may prescribe it when other treatment options don’t work for severe morning sickness.
This is considered to be an off-label use.
But how does it work?
Taking ondansetron works by temporarily blocking a type of receptor in your intestines that can cause nausea and vomiting.
Is Zofran® Safe for Pregnancy?
This is a big question for many women. The simple answer is that the jury is still out.
The Food and Drug Administration (FDA) lists Zofran® as a Category B drug. This means that animal studies haven’t shown a risk to a fetus. But, because there are no “adequate and well-controlled studies in pregnant women”, we don’t know for sure.
This is where a lot of the concern around the drug’s use in pregnancy comes from.
The available data on the risk of birth defects from ondansetron use are a little inconsistent and sometimes conflicting.
Here’s an example. One study found that there was no increased risk of major birth defects from taking Zofran® during pregnancy.
But other research has found a small increased risk of a heart-related birth defect. However, this association is not consistent across other studies.
Let’s take a closer look at what the science says.
While studies have found that the overall risk of birth defects is low, there may be a small increase in the incidence of cardiac abnormalities (heart defects).
But the review also says that this link is not consistent.
Because of this, researchers suggest that ondansetron use for nausea and vomiting of pregnancy isn’t for everyone. They say it should be reserved for women whose symptoms have failed to lessen or disappear by other methods.
Another study looked at over 60,000 pregnancies. It found that there was no increased risk of:
- Spontaneous abortions
- Stillbirth
- Birth defects
- Other adverse pregnancy outcomes
A different study looked at the use of ondansetron during the early stages of pregnancy. It found that taking Zofran® was linked to an increased risk of a baby having a cleft palate.
But other researchers found no such risk.
Some have noted a higher risk of heart problems, especially if a pregnant woman takes a large dose of ondansetron. For this reason, some physicians are cautious about prescribing it in the first trimester.
It’s also important to note that ondansetron has been linked to heart rhythm problems in people taking the drug. This is especially true for those with certain health issues. This is a rare but serious side effect. It’s called torsade de pointes, and it’s a rare type of fast heart rhythm.
As you can see, the research on taking Zofran® during pregnancy can be confusing and sometimes conflicting.
Here’s the general takeaway: Most studies find that the overall risk of birth defects with ondansetron is low. But it’s not zero.
Clearly, more research is needed to be absolutely sure.
Is Zofran® Safe During Breastfeeding?
This is another common question for women who have just had a baby.
Ondansetron is one of the commonly used antiemetic medications during and after a cesarean section. But don’t worry. Using Ondansetron after a C-section does not affect the start of breastfeeding.
This anti-nausea drug is also approved for use in infants as young as one month old. So, physicians feel it’s safe for infants. No serious or adverse drug reactions have been reported in infants whose mothers took ondansetron.
Is Zofran® Safe During TTC?
Are you TTC (trying to conceive) and worried about taking Zofran®? You can put your worries aside. Animal studies have not found that ondansetron affects the ability to get pregnant.
What Are the Alternatives to Zofran®?
There are other treatment options if:
- You want to avoid taking Zofran®
- You and your doctor decide it’s not the right medication for you
The only FDA-approved drug for morning sickness is a drug called Diclegis. It’s a combination of two things you may have heard of:
- Delayed-release doxylamine succinate (an antihistamine)
- Pyridoxine hydrochloride (vitamin B6)
This drug has a FDA Pregnancy Category A status. This means that a good number of well-controlled studies have not shown any risk to the baby in the first trimester of pregnancy.
This makes it a good first choice for many women who are pregnant.
And, sometimes, just changing your habits can help with morning sickness syndrome.
Some women find that non-pharmacological methods like ginger capsules or candies help to prevent nausea. Eating small, frequent meals and avoiding food that triggers nausea can also help.
What if you have intense morning sickness? The kind where you may be losing weight or getting dehydrated? This condition is called hyperemesis gravidarum. And it is serious. It requires medical care to ensure both maternal safety and good pregnancy outcomes.
In this case, your doctor may still recommend a medication like Zofran® if other medications haven’t worked.
The Bottom Line
The decision to use ondansetron and other drugs during pregnancy depends on one major thing. This is whether the benefits of these drugs are greater than their potential risks.
For a doctor, it’s important to weigh the risk of a potential medication side effect against the risk. In this case, it’s the risk of a woman being so sick from severe morning sickness that she can’t eat or drink. This can harm both her and her baby.
Whether or not to take Zofran® is a decision you and your doctor should make together. Your doctor can discuss the factors with you to determine the best treatment for you and your baby.
FAQs
The short answer? The research is still mixed, so doctors are a little cautious.
The FDA lists it as a Category B drug. This means there aren’t enough complete studies on pregnant women to say for sure.
Most studies show a low overall risk of birth defects with this medication. But some have found a slightly higher risk of things like heart defects and cleft palate.
The decision to use Zofran® for nausea and vomiting is best made with your healthcare provider. This allows you both to consider your personal symptoms and health.
The first trimester is when a baby’s organs are developing. Because of this, it’s a point of concern for some physicians.
Zofran® is sometimes prescribed for intense morning sickness symptoms in early pregnancy. But some studies suggest a link to certain birth defects during this time.
You and your doctor can talk about these potential risks to decide if taking Zofran® in early pregnancy is best.
The right Zofran® dosage is something your healthcare provider will determine for you. It depends on your symptoms and overall health.
Your doctor will tell you exactly what your Zofran® dosage is and how often it should be. It is very important that you never take more of the drug than what is prescribed to you.
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