Whenever pharmaceutical companies send a drug to market or a doctor prescribes the medication to a patient, the risks of potential side effects must be weighed against the benefits to the person receiving the medication. The prescribing of Zofran to pregnant women experiencing nausea and morning sickness is arguably irresponsible due to the lack of regard taken toward unborn children who are affected by the medication in different ways than their mothers.
GlaxoSmithKline skirted its responsibilities when it recommended the use of a medication that was previously approved for the treatment of nausea in chemotherapy patients for the treatment of morning sickness without first proving that the medication was safe to administer during pregnancy and countless children and their families have suffered as a result.
Side Effects Linked with Zofran Use
While Zofran hasn’t been linked to serious side effects in the mother, studies have linked the drug to numerous birth defects and conditions in children whose mothers were prescribed the medication in their first trimester. Many of the side effects seem to be the result of impaired development or malformation of vital organs and include the following.
- Cleft lip or palate— this condition is the result of the failure of the child’s palate or lip to develop fully prior to birth and results in serious accompanying conditions that include speech impairment, scarring, dental problems and diminished hearing. See page here.
- Increased risk of heart disease— mothers who have taken Zofran exhibited twice the risk of delivering a child with the potential for heart problems than those who refrained from Zofran usage. Children may be at risk of developing heart conditions later on in their lives even if those problems are not diagnosed at birth.
- Heart murmur— while not always a symptom of a condition itself, a heart murmur may point to weak or malformations in the valves of the heart. Children with heart murmurs are more likely to develop infections or experience more complicated heart problems.
- Congenital heart defects— as mentioned previously, Zofran is linked to deformities and the failure of organs to form correctly. Pregnant women taking the drug experience giving birth to a child with birth defects and most of the cases involve heart malformations and defects. Atrial septal defects refer to holes in the upper parts of the heart while ventricular septal defects refer to deformities in the lower areas of the heart.
Zofran Marketed Illegally by GlaxoSmithKline
After receiving approval for Zofran in the treatment of nausea for patients undergoing chemotherapy, GlaxoSmithKline began to advise that it be prescribed to others suffering from nausea— including pregnant mothers in their first trimesters. This recommendation came without any prior research on the effects of the medication on unborn children and the approval of the drug by the FDA did not cover its use for the purpose of treating morning sickness.
After linking the medication to numerous birth defects and negative side effects, further investigations are underway with the intention of opening litigation against GlaxoSmithKline for its failure to disclose potential side effects and risks associated with Zofran and for its illegal marketing of the medication for the treatment of morning sickness.
If you were prescribed Zofran during your first trimester of pregnancy and your child suffers from birth defects, you may be entitled to the recovery of compensation for the ongoing care of your child in treating any conditions related to his or her birth defects.
Ready to Take the Next Step? Get Help Now From our Zofran Birth Defect Attorneys
Rosenfeld Injury Lawyers is at the forefront of Zofran litigation and is ready to help you learn more about your rights as a patient and a parent during a free consultation with an attorney. We will be happy to evaluate the details of your case and to investigate further in order to determine whether it is in your best interest to pursue a lawsuit for medical malpractice or a product liability claim. Our attorneys will only receive payment if we are able to successfully collect compensation on your behalf and if we fail to do so, you will owe us nothing.