GlaxoSmithKline, the sixth-largest pharmaceutical company in the world, manufactures Zofran. Zofran is approved only to treat the nausea and vomiting associated with radiation, chemotherapy and specific types of surgical procedures. Zofran contains Ondansetron hydrochloride dehydrate, also known as a 5HT3 antagonist. Zofran blocks the receptors in the brain which sent “nausea” messages. Zofran comes in tablets, syrup, intramuscular injection, IV infusion and suppository form.What are the Risks Associated with Zofran?
While not approved to treat morning sickness in pregnant women, Zofran has been widely prescribed off-label to do so. Unfortunately, considerable research has linked Zofran, when taken during the first trimester of pregnancy, to an increased risk of serious birth defects. Babies born to women who took Zofran to treat their morning sickness have been born with cleft palate, club feet, heart defects and a condition in which the skull is abnormally shaped without sufficient space for the brain. This condition known as craniosynostosis may cause eating problems, mental impairment and vision loss.Research on Zofran and the Potential to Cause Birth Defects
More than 10,000 birth records were studied by Harvard and Boston University researchers. The conclusion was that women taking Zofran during the first trimester for extreme nausea had twice the risk of having an infant with cleft palate. Danish researchers looked at birth records from 1997 to 2010; of more than 900,000 live births, 1,368 women took Zofran during their first three months of pregnancy. Nearly five percent of those delivered infants with serious birth defects.
The Danish study concluded babies exposed to Zofran during the first trimester of pregnancy were between two and nearly five times as likely to suffer from a congenital heart defect, most specifically a hole in the heart. A 2014 Swedish study arrived at many similar conclusions; the study found that infants exposed to Zofran during the first trimester were 1.6 times more likely to be born with a congenital heart defect.Why are Doctors Prescribing Zofran Off-Label for Morning Sickness?
Doctors commonly prescribe drugs off-label—in fact as many as one in five prescriptions currently being written in the United States are for off-label use of a drug, meaning the drug is being used in a manner not specified by the FDA. While doctors are allowed to prescribe drugs off-label, drug manufacturers are not allowed to promote drugs for any use other than those approved by the FDA and stated in the accompanying labeling.
GlaxoSmithKline, however, actively promoted Zofran for use in pregnant women, resulting in doctors assuming the drug was safe for that use. Despite the number of drugs which are prescribed off-label, most patients are unaware they are receiving an off-label prescription since doctors are not required to disclose that information. Zofran labeling does not include warnings regarding Zofran birth defect risks despite animal studies done in the 1980’s which indicated the drug might not be totally safe for pregnant women.The FDA’s Stance on Zofran
Zofran is classified by the FDA as a Pregnancy Category B medication which means animal studies are inconclusive, but no one really knows whether the drug is safe or not. Reportedly, when GSK submitted Zofran to the FDA in 1991, the only data submitted with the drug which addressed the issue of birth defects were from experiments conducted in the mid 1980’s on mice and rabbits.
The data is questionable, however, since mice have a gestational period of 21 days and rabbits, 33 days. The animals in the study were given Zofran for ten days, however the drug was started on the seventh day which effectively skipped over the first trimester. In 2013, the FDA issued an updated warning for Zofran when used off-label for morning sickness. This warning cautioned against the use of Zofran during pregnancy.Did Your Child Suffer Zofran-related Injury?
If you were prescribed Zofran during the first trimester of your pregnancy and your child was born with a birth defect, you could benefit from speaking to a knowledgeable Zofran birth defect attorney. Zofran birth defects are very real—if you were not told of the potential risks when you were prescribed Zofran, you may be entitled to compensation from the manufacturer.Contact Our Jackson Dangerous Drug Lawyers
If your child was born with a birth defect after you were prescribed Zofran during your pregnancy, it is important to speak to a knowledgeable and experienced Jackson dangerous drug lawyer immediately. At Coxwell & Associates, PLLC, our attorneys believe in holding negligent pharmaceutical companies responsible for the dangerous drugs they produce. We also believe in fighting aggressively for injured victims – to ensure that they receive the money they need to fully recover. Contact Coxwell & Associates today at 1-601-948-1600 or 1-877-231-1600.