2013 Study on Zofran

Pregnant mothers spend a lot of time making sure their bodies are healthy for their children by eating right, exercising, and taking care of their hygiene. For pregnant women dealing with intense morning sickness and other gestational side effects, finding the right treatment options can be overwhelming. They want to be sure that whatever medication or treatment options that are given to them are effective while being safe for the health of their baby. There was a time where the drug Zofran was an answer to many pregnant patients; however the drug received a lot of national attention when a Zofran study was conducted, which uncovered some startling information.

Zofran History

The commonly prescribed drug Zofran was developed in 1991 as an intravenous treatment of nausea after chemotherapy. Changes to the drug were implemented over time until a pill form was approved in 1999. A generic version was finalized in 2006.

Doctors began prescribing Zofran off-label to pregnant mothers to fight off severe morning sickness. For women suffering nausea and vomiting during pregnancy, this was a much needed treatment option. But the relief was short-lived. A 2013 study found that Zofran, when used in early pregnancy, may be connected to a host of maternal side effects and birth defects, such as cleft lip and cleft palate.

According to the FDA, Zofran is extremely dangerous to pregnant women – a claim that GlaxoSmithKline, the manufacturer of the drug, failed to disclose. In 2012, a lawsuit was filed against the pharmaceutical company after it was found that they were promoting off-label use of Zofran. Since then, many women have been coming forward with reports of a multitude of Zofran side effects, including:

• Rashes, hives, and itching
• Shortness of breath
• Body swelling
• Constipation
• Irregular heartbeat
• Dizziness
• Fainting
• Difficulty breathing and swallowing

Birth defects and complications have also been reported, including cleft lip and cleft palate, growth restriction, club feet, heart defects, abnormal skull development (which does not leave enough room for the brain), and infant death. In 2012, over 190 reports were called in to Motherisk, a non-profit Canadian organization that handles questions and concerns for pregnant mothers.

Zofran Study in 2013

In 2013, a study of over 900,000 Danish women who were prescribed Zofran found a “two-fold increased risk of cardiac malformations, leading to an overall 30% increased risk of major congenital malformations.” This Zofran study found that 58 out of the 1,248 women who took this drug in the first trimester gave birth to a child with a birth defect, meaning that the drug caused a 30% increase in risk. Other studies have found that, if taken after the time when malfunctions could develop, this drug poses no danger. Though conflicting data surrounds this claim, over 1 million women are still prescribed this drug every year. There is no substantiating evidence that the drug is safe for pregnant women.

The drug works as a 5-HT3 receptor antagonist, which affects serotonin in the brain, numbs the feeling of nausea, and prevents vomiting. However, the same method which the drug staves off also disrupts chemicals in the brain during electrolyte imbalances. It is dangerous to people who have a preexisting electrolyte imbalance, like pregnant women. When given to pregnant women, the drug causes what’s knows as Serotonin Syndrome, which leads to a change in cognitive and behavioral abilities, such as confusion, agitation, instability, and neuromuscular changes. This is in addition to its association with birth defects.

GlaxoSmithKline pled guilty to the 2012 lawsuit, which claimed unlawful promotion and failure to report safety data. It has since paid over $3 billion in resolve charges. Currently, mothers of babies who suffered birth defects are bringing lawsuits against the pharmaceutical giant for their failure to include a warning about birth defects on the label.

If you have taken Zofran and suffered severe side effects, or have given birth to a child with birth defects, contact a Zofran lawsuit lawyer at Knapp & Roberts today.