The drug Zofran (Ondansetron) has been linked by at least four studies
to an increased risk of birth defects. Zofran was approved by the FDA in 1991
only for the treatment of nausea experienced by chemotherapy and radiation
patients, as well as for patients who experienced nausea following a surgical
procedure. Zofran officials, however, touted the drug to doctors as a
cure for severe morning sickness experienced during the first trimester
of pregnancy. This is known as “off-label” use, and, while
off-label prescribing is fairly common, it can lead to serious medical issues.
In this case, studies have found that when pregnant women take Zofran during
the first trimester of their pregnancy, severe birth defects can result.
One epidemiological review performed by researchers at Harvard and Boston
University which studied more than 10,000 birth records concluded women
who took Zofran for morning sickness were more than twice as likely to
deliver a baby with a cleft palate. Three additional studies have found
increased risks of birth defects when Zofran is taken during the first
three months of a woman’s pregnancy.
Danish researchers conducted a second study of birth records filed between 1997 and 2010 after a first noted no increased
risk of major birth defects in babies exposed to Zofran. The first study
was considered biased because more than half the women in the study took
Zofran after the first trimester. The second study included only women
exposed to Zofran during the first trimester. Out of more than 900,000
live births, 1,368 of the mothers took Zofran for severe morning sickness
during the first trimester. Approximately 4.7 percent of those mothers
gave birth to children with major birth defects as compared to 3.5 percent
in the group of mothers who did not take Zofran. Researchers translated
these numbers into a 20 percent increased risk of major congenital defects
for those taking Zofran in the first trimester. Conclusions were that
babies exposed to Zofran were 2.1 times more likely to suffer an atrial
septal defect, 4.8 times more likely to suffer a atrioventricular defect
and 2.3 times more likely to experience a ventricular septal defect. These
defects are commonly known as a hole in the heart and are the result of
cardiac tissues which do not develop properly.
A Swedish study published in December, 2014, came to many of the same conclusions as the
Danish study. Records were compiled from the Swedish Medical Birth Record
for a period of fifteen years (1998-2012), identifying 1,349 babies born
to mothers who took Zofran during the early months of pregnancy. The incidence
of heart defects and cleft palate in the group of babies born to women
who took Zofran was compared to all other births during the same time
period. The Swedish study found babies exposed to Zofran were approximately
1.6 times more likely to have a congenital heart defect.
In 2013, an Australian medical journal published a study regarding the off-label use of Zofran among expectant mothers. Western
Australian birth records between 2002 and 2005 were compiled, determining
that 251 women out of more than 96,000 had taken Zofran during the early
months of pregnancy. The Australian study found a 20 percent increased
risk of major birth defects among women who took Zofran during the first
trimester of their pregnancy. A seven-fold increase in the risk of kidney
malformations was also found. It was noted that this particular study
may have been too small to properly assess the actual risks of Zofran
Lawsuits Filed Against the Manufacturer of Zofran
Lawsuits have been filed against the manufacturer of Zofran, GlaxcoSmithKline
(GSK). These lawsuits allege GSK was well aware of the potential dangers
associated with Zofran when taken by pregnant women. No clinical human
trials were conducted in order to determine whether Zofran is safe for
use in pregnant women, although animal studies in pregnant rabbits and
rats were performed in the late 1980’s. Each of four animal studies
revealed signs of toxicity including lethargy and abnormal postures in
the pregnant animals and impaired bone growth in the babies when Zofran
was administered during early pregnancy. It is expected more Zofran lawsuits
will be filed as more information regarding Zofran risks surface.
Contact Our National Dangerous Drug Lawyers
If you took Zofran during the first trimester of pregnancy and your baby
was born with a congenital defect, it is important to speak one of the
experienced national dangerous drug attorneys at Golomb & Honik immediately.
Our lawyers can answer all your questions regarding the current Zofran
litigation and determine if you are eligible to file a lawsuit against
the manufacturers of Zofran.