Is Zofran Safe During Pregnancy?

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Many health care providers are prescribing Zofran during pregnancy, or by its generic name Ondansetron, to treat severe morning sickness. I’m concerned about the health of my baby and I want to know is Zofran safe during pregnancy? Zofran is used to prevent nausea in patients receiving surgery or chemotherapy. Use for morning sickness is an off-label use. This medication was not approved for use in pregnant women and was never absolutely proven to be safe for unborn babies.

Can you take Zofran while Pregnant?

Lately, there have been some unsettling studies about taking Zofran while pregnant. In 2013, the FDA issued a warning against Zofran for morning sickness, but some healthcare professionals continue to prescribe it. If you are currently pregnant and using Zofran, you need to be aware of these potential safety issues.

Zofran and Cleft Palate Birth Defects

To date, most studies done on the use of Zofran during pregnancy have been reassuring, finding no significant increase in birth defects and other adverse events associated with use during pregnancy. However, a much larger study of more than 9,000 births has found a twofold increase in birth defects of cardiac and oral defects in infants whose mothers used the drug in the first trimester of being pregnant. The most common oral defect was cleft palate. Cleft Palate disorders are common birth defects that occur early during pregnancy. Tissues that form the lip and mouth normally fuse within weeks 8 and 12.

Zofran in Pregnancy FDA Warning

There are also issues that increase the health risks of pregnant women. In May 2013, the FDA warned that the drug may cause Serotonin Syndrome, a potentially life-threatening condition. The risk is greatest for women who take selective serotonin reuptake inhibitors, or SSRIs, but it can happen to anyone taking Zofran. Symptoms of Serotonin Syndrome range from shivering and diarrhea to high fever, seizures, and even death. Women experiencing any symptoms should seek emergency care and especially those who are expecting considering is Zofran safe during pregnancy.

Zofran is not new to the FDA watchlists, however. In 2012, the organization first warned that Zofran increases the risk of a lengthened Q-T interval, which is associated with fainting, seizures and sudden death. While the most common symptom of this condition is fainting spells, it often produces no symptoms and is detected only during an EKG (What is an EKG?). While fainting is the most common symptom of an increased Q-T interval, most pregnant women who are experiencing fainting spells do not have this condition.

Zofran Side Effects During Pregnancy

Severe morning sickness has its own risks. Also known as hyperemesis gravidarum, severe morning sickness can lead to weight loss, dehydration and electrolyte imbalance. If allowed to continue, severe morning sickness can lead to miscarriage, premature birth or even organ failure. Severe morning sickness should be treated with medication, and, if necessary, intravenous fluids.

Some women with severe nausea and vomiting will respond to the traditional morning sickness remedies. Ginger, mint, hard candies, small meals throughout the day, eating bland foods, and having a small snack before getting up in the morning are always to help with morning sickness.

Some women, however, still need more help. Diclegis is a medication that has been FDA approved specifically to treat morning sickness. It is also in pregnancy category A, meaning that it has been tested and found to have no adverse effects on women or their unborn babies.

Some providers will continue to prescribe Zofran as nausea medicine for pregnancy, and most expecting mothers will ask, “Is Zofran safe?” If you are currently taking Zofran for severe morning sickness, contact your healthcare provider with any concerns, and if you experience any of the above warning signs, contact your provider or seek emergency care.