With "safe and effective" drugs now available to help women suffering
from nausea and vomiting during pregnancy, "there is no reason for
women to be exposed to a drug of unproven maternal and fetal safety"
such as Zofran, Dr. Gideon Koren writes in a recent medical journal article.
The article by Dr. Koren, a Toronto physician who is considered one of
the world's foremost authorities on medication use during pregnancy,
was published in the December 2014 issue of the
American Journal of Obstetrics & Gynecology.
Dr. Koren's call for changes in the way Zofran has been prescribed
to pregnant women in the U.S. for treatment of morning sickness comes
at a time when numerous
product liability lawsuits are being filed against the manufacturer of Zofran, GlaxoSmithKline.
The lawsuits tend to claim that the children of mothers who used Zofran
during the first trimester of pregnancy have suffered birth defects, including
heart defects and cleft palates.
What Is Zofran?
U.S. Food and Drug Administration (FDA) describes Zofran as a 5-HT3 receptor antagonist that blocks serotonin,
which is a naturally occurring substance in the body that causes nausea
and vomiting. The drug's generic name is ondansetron.
The FDA has approved Zofran to be prescribed to patients experiencing nausea
and vomiting due to cancer chemotherapy and surgery.
However, as Dr. Koren points out in his article, Zofran has been increasingly
prescribed for "off-label" use as a way to ease morning sickness
in pregnant women.
According to Dr. Koren, prescriptions for that use rose from 50,000 per
month in 2008 to 110,000 per month by the close of 2013 "despite
unresolved issues regarding fetal safety and
[FDA] warnings about serious dysrhythmias."
In fact, Dr. Koren points out, nearly 98 percent of the drugs prescribed
to treat nausea and vomiting in pregnant women are not labeled for that use.
Study Finds Increased Zofran Birth Defect Risks
In his article, Dr. Koren discusses a study that was presented to the International
Society of Pharmacoepidemiology in August 2013.
In the study, Danish researchers examined the records of 1,248 women who
were prescribed Zofran (ondansetron) during the first trimester of their
pregnancy. Out of those women, 4.7 percent gave birth to a child with
a "congenital malformation." In contrast, only 3.5 percent of
those women who were not exposed to the drug had children with birth defects.
According to the study, this meant that Zofran use by women in the first
trimester of pregnancy created a 30 percent increased risk of birth defects
in their children.
Our Zofran Birth Defects Lawyers Are Here to Help You
The Maher Law Firm currently is reviewing cases of birth defects in children
who were born to women who took prescribed Zofran to treat morning sickness
early in their pregnancy.
We believe that these mothers owe it to themselves and their children to
have their case fully investigated and to understand their legal rights
To schedule a free and confidential consultation, contact us today by phone
or through our convenient