San Diego, CA–April 10, 2015
The fear and concern swirling around the health of a newborn child can be consuming. There is already plenty of natural risk during childbirth that can cause worry for expecting mothers.When the symptoms of pregnancy such as fatigue and “morning sickness” start to kick in,treatment is something that should be approached carefully.
For many pregnant women the anti-nausea drug Zofran was prescribed as an off label solution for morning sickness. These women were prescribed Zofran despite its extreme side effect potential.
Studies starting as early as 2011 have consistently shown the severe birth defects that Zofran have been directly linked to. Deformations such as cleft lip/palate, heart defects, hearing loss,and infections. The drug was originally approved by the FDA as an anti-nausea pill to treat patients who have gone through chemotherapy and radiation treatments. With the amount of women affected, it is clear that the off label application of Zofran towards pregnant women has been a grossly irresponsible and unsafe reallocation of the drug’s intended use.
The trauma that comes with a deformity like cleft lip/palate can go beyond the physical. Cleft lip and palate are described as a split or opening in the roof of the mouth and lip. When children are born with these deformities, immediate health risks come into play. Malnutrition becomes a threat because the child’s mouth cannot form a seal for feeding, and they are unable to intake some food and liquids.Additional complications are caused by the ways that cleft palate malforms the upper airway and increase amount of fluid that reaches the middle ear. This causes recurring infections that lead to potential hearing loss. Lip deformities can also stunt early progress with a young child’s speech. This, in turn, prevents undemanding vocal communication, and can affect how a child is able to learn and express during their most developmental ages. Speech therapy,special education and special bottles, and avoidance of breastfeeding are often required to compensate for these losses.
Other Possibly Related Zofran Birth Defects
The adverse outcomes caused by Zofran are not only limited to cleft lip/palate. Heart problems such as ASD (Atrial Septal Defect) and VSD (Ventricular Septal Defect) are two extreme heart conditions that can occur as a result of taking Zofran. These side effects cancause horrific defects that require newborn babies to require immediate surgery. A child born with multiple holes in their heart, abnormal sounds and heartbeat cycles, and other heart pains and weaknesses are all side effects that are avoided significantly by the avoidance of taking Zofran during pregnancy.
The risk of death, adverse outcomes, and physical abnormalities can all be linked to the chemicals within Zofran. Ondansetron, the active component in Zofran, continues to cause these side effects while the National Institutes of Health have stated that “ondansetron use cannot be assumed to be safe during pregnancy.”
Despite this knowledge, the maker of Zofran, GlaxoSmithKline, has aggressively marketed the drug to be prescribed for pregnant women. As recently as 2012, GlaxoSmithKline has plead guilty to promoting Zofran for unapproved uses, and have since paid billions in liability penalties. In this case, one of the biggest drug company fraud cases in United States history, it becomes increasingly difficult to trust the treatment of pregnancy symptoms with prescription drugs.
It is important to both remain educated and informed, as well as hold companies like GlaxoSmithKline accountable for their unsafe off label marketing.While seeking treatment it is advised to contact a healthcare professional and discuss responsible options. For those already affected by Zofran, it is equally important to determine their compensation eligibility by filling out the Zofran Claims Compensation Form –click the banner below – it only takes two minutes to see if you qualify.
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