Zofran was developed to help cancer patients who were experiencing nausea and vomiting. The FDA approved Zofran in 1998. It was originally indicated for chemotherapy-induced nausea and vomiting, and was also approved to treat nausea and vomiting associated with radiation therapy, anesthesia, and surgery.
Zofran was never approved for use in pregnant women to treat nausea, morning sickness, or hyperemis gravidum, which is the most severe form of morning sickness. Nevertheless, GlaxoSmithKline (“GSK”) aggressively marketed the drug for off-label use to treat nausea in pregnant women. In 2012, GSK agreed to pay $3 billion in penalties to resolve a federal whistleblower lawsuit that included claims that GSK wrongfully promoted Zofran for off-label use by pregnant women, and for paying kickbacks to physicians to prescribe Zofran for such off-label use. If you’ve ever seen the movie, “Love and Other Drugs,” these practices might sound familiar.
Zofran and Birth Defects
A large control study published in November 2011 by the Slone Epidemiology Center in Boston and the Centers for Disease Control and Prevention, found a twofold increased risk of cleft palate in babies whose mother had taken Zofran in the first trimester of pregnancy. A Danish study, which was presented in August 2013 at the International Society of Pharmacoepidemiology meeting in Montreal, revealed a twofold increased risk of congenital heart defects in babies whose mother used Zofran during the first trimester.
Cases in which mother took Zofran in the first trimester and baby was born with or died from heart defects or a cleft lip or palate are being investigated and will likely result in nationwide litigation. Other symptoms of Zofran-related heart defects may include kidney or urinary problems, abnormal heart rhythms, AVM, a lung problem known as “persistent pulmonary hypertension,” and restricted growth of the baby in utero. If you took Zofran during your pregnancy and your baby has any of these conditions, you should ask your doctor to check your baby’s heart.
Michael Phelan is a Virginia trial attorney who practices with a special focus on traumatic brain injury (TBI) cases, pharmaceutical and medical device claims, product liability cases, and truck accidents. Michael’s peers have consistently recognized him for his excellence as a trial lawyer, and his clients have praised him for his commitment to deep research, his outstanding communication skills, and his sincerity and dedication.