Birth Defects Linked to Zofran Use
Was your child born with a cleft lip, cleft palate, or congenital heart defect (CHD)? These are birth defects that are present collectively in more than 47,000 newborns in the US every year, with CHD being the most common. In most cases, the causes of these birth defects are unknown, and parents are encouraged to look upon it as nothing more than the roll of the dice. However, there are studies into these types of birth defects that link them to the use of certain drugs. One of these is Zofran (ondansetron) manufactured by GlaxoSmithKline.
Zofran is a powerful antiemetic (prevents nausea) that blocks 5-HT3 receptors in the central nervous system and the gastrointestinal tract. It is customarily prescribed as per Food and Drug Administration (FDA) approval for the prevention of severe nausea in patients undergoing chemotherapy or radiation therapy (using cytotoxic drugs) and post-surgery. In some cases where morning sickness is so severe that the mother is put in danger of severe dehydration and electrolyte imbalance from constant vomiting (hyperemesis gravidarium), she may be prescribed with Zofran or its generic counterparts.
The problem with this is Zofran is not approved for use in pregnant women. In fact, all antiemetics are not recommended for use during pregnancy because there are not enough studies to validate any risk-benefit analysis. However, when severe morning sickness threatens the health of the mother and child, physicians have no choice but to prescribe one. There are no warnings published by the manufacturer that Zofran poses a greater risk of birth defects to the developing fetus than any other antiemetic, so physicians have no reason to believe that it will harm the child. Ongoing studies indicate that Zofran may in fact be particularly prone to increase the risk of birth defects.
If you have been prescribed with Zofran and your child is born with a birth defect, you may want to consider filing a Zofran lawsuit. The manufacturer knew or should have known that it would pose unreasonable dangers to your child, and should have provided adequate warning to doctors and the public against its use. Contact a dangerous drugs lawyer in your state to explore your legal options in such cases.