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Zofran during pregnancy

Updated on August 22, 2016

The Rickmans are suing GlaxoSmithKline, manufacturers of Zofran, alleging that the drug company illegally marketed the drug for use in pregnant mothers and withheld information about the drug's safety and effectiveness.

When obstetricians, gynecologists and other physicians prescribe Zofran to pregnant women, they are doing so “off label” While “off label” drug prescription is surprisingly common, the practice is rarely backed by adequate scientific evidence.

Numerous lawsuits have been filed alleging that the drug maker failed to disclose the risks of birth defects to women who were prescribed the drug.

The drug Zofran is designed to limit nausea but it was not approved for use by pregnant women and it may cause birth defects.

In 2013, a Danish study of nearly 900,000 pregnant women found that those taking Zofran had a 30% increased risk of birthing a child with major malformations, including a twofold increased risk of cardiac defects.

Specifically, the study assessed the risk for birth defects amongst infants born to women using Zofran or other medication during pregnancy, as opposed to those born to women who did not take Zofran.

In addition to potential Zofran birth defect risks, potential maternal risks have been found with Zofran pregnancy use especially in women with electrolyte imbalances caused by severe nausea and vomiting, including hyperemesis gravid arum.

Critics have questioned this study's validity, since many of the women took Zofran after their first trimester when the risk of birth defects is much lower.

When the antinausea drug Zofran is used during pregnancy, studies have found a 30% increased risk of birth defects, a doubled risk of “hole in the heart” defects, and even higher rates of cleft lip and cleft palate.

In many cases, women who used Zofran during pregnancy admitted that, had they known about the alleged pregnancy risks association with Zofran, they never would have taken the drug in the first place.

Zofran® is commonly used by doctors to reduce nausea in pregnant women, even though the drug has not been approved to treat morning sickness.

No dosage of Zofran has been submitted to the FDA for safety testing on pregnant women, and no Zofran dosage or form has been approved by the FDA to be free of pregnancy side effects or safe from causing birth defects.

For example, Zofran has not been approved for use in pregnant women but is frequently prescribed off-label to treat morning sickness.

Zofran side effects on the fetus were never studied or considered by the FDA as it was approved only to be a nausea drug for chemotherapy patients, not pregnant women.

Zofran is far from unique—almost every drug prescribed during pregnancy in the United States is "off label," meaning it hasn't gone through the clinical trials required by the Food and Drug Administration before approving a drug for a specific use in a specific population.

Unfortunately, the FDA has not stopped Zofran or the generic form of the drug from being prescribed to pregnant women.

Some doctors have prescribed Zofran off-label to treat nausea and vomiting caused by morning sickness in pregnant women, though the drug has never been approved for this use.

Cardiac birth defects are among the most common adverse events reported by pregnant women who were prescribed Zofran.

This means that children born to women using Zofran during pregnancy were found to have six times the rate of these kinds of kidney defects as compared to those born to women who did not take Zofran during pregnancy.

The lawsuits allege that the drug, when taken during the first trimester of pregnancy, caused children to be born with serious birth defects—and even worse, that the drug's manufacturer GlaxoSmithKline knew about Zofran's potential for harm.

A recent study from researchers at the Statens Serum Institut in Copenhagen found that the drug Zofran, which is used to treat nausea and vomiting, is safe to use during early pregnancy and poses no increased risk to the developing fetus.

Gideon Koren published in the December 2014 issue of American Journal of Obstetrics and Gynecology highlights the risks of pregnant women taking Zofran and conflicting studies that cannot rule out dangers to a fetus.

Several years later, research published in the medical journal Birth Defects Research indicated that expectant mothers who took Zofran to treat their morning sickness faced a 4times higher risk of giving birth to babies with cleft palate birth defects.

For instance, an earlier and smaller study of 176 women found no connection between the drug and malformations, but the sample size was too small to detect any risk that was less than threefold.

In 2014, the American Journal of Obstetrics and Gynecology published a study highlighting increased risks of serious cardiovascular incidents in pregnant women taking Zofran and discussing conflicting studies that could not rule out similar dangers to the fetus.

The highest risks occur in the first trimester, when this drug is also most likely to be used by pregnant women.

Although medical causation is not settled on the issue, many women who took Zofran during pregnancy gave birth to children with birth defects.

Another 2014 study, published in the American Journal of Obstetrics and Gynecology, that analyzed data from almost 900,000 pregnancies in Denmark, reported a twofold increased risk of congenital cardiac malformations and a 30 percent increase in major congenital malformations associated with ondansetron use by pregnant mothers.

In September 2011, the FDA issued a Drug Safety Communication that warned of Zofran side effects, namely congenital heart defects in the fetuses of women taking Zofran.

Reference: Zofran during pregnancy

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FDA warns against the use of Zofran in pregnancy as it comes under the section B medication. Medicines that come under the section B medication are known to be causing potential risks to the pregnant women and her unborn child. Some of the risks caused to the other are as follows: Agitation, irritation, anxiety, Serotonin syndrome, alteration in neuromuscular area and the autonomic instability. These are some of the reasons as to why it is prohibited to consume Zofran during the time of pregnancy.

Therefore, even the doctors today are refraining from prescribing the dosage of Zofran to the pregnant women. Now women prefer bearing some of the side effects of motherhood than the side effects of Zofran. The loss due to the drug irreparable.


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