At the conclusion of a special session
hosted by The Reproductive Toxicology Center (RTC) as a satellite conference
of the World Conference FIGO 2000 (International Federation of Obstetricians
and Gynecologists), Dr. Anthony Scialli, head of the Center, stated that
science and medical thinking have made significant progress in recognizing the
potentially adverse health effects of untreated pregnancy-induced nausea and
vomiting on the women and their babies.
According to Dr. Scialli, recognizing this disorder as a medical condition
is a breakthrough in itself, since the symptoms of nausea and vomiting of
pregnancy (NVP), commonly called "morning sickness", had long been associated
with the pregnant woman's state of mind and therefore treatment was considered
to be unnecessary.
The Conference's host stated that "Although NVP is often considered a
normal part of the pregnancy, it is important for the medical community to
realize that, aside from the economic burden associated with untreated
persistent symptoms, NVP also affects the physical, social and psychological
state of the pregnant woman and her family."
Dr. Janine E. Polifka, a member of the Session's panel of speakers and
Project Director of the Teratogen Information System, stressed the fact that
"many physicians are reluctant to prescribe antiemetic medications during
pregnancy, particularly since symptoms associated with NVP occur during the
first trimester when the embryo is particularly vulnerable to the potentially
teratogenic effects of drug."
Dr. Polifka also pointed out that "the only FDA-approved drug for NVP is
Bendectin (doxylamine/vitamin B6), and that the best data available regarding
fetal safety are still for this compound. But American women have been
deprived of Bendectin since 1983, when its manufacturer decided to discontinue
its production because of the litigation cost resulting from unsubstantiated
claims of birth defects allegedly associated with the drug. Although
Diclectin(R) (the generic version of Bendectin) is approved and available in
Canada as the only first line pharmacological treatment specifically labelled
for nausea and vomiting of pregnancy, there is no commercial version of the
compound currently available in the United States."
Dr. Scialli concluded by stating that "American women suffering from
nausea and vomiting of pregnancy should benefit from scientific and medical
progress. They should have access to the best health care and proven-safe
treatments to prevent further problems for them and for their babies.
Therefore I am happy that the FDA has reconfirmed that Bendectin was not
withdrawn from sales for reason of safety or effectiveness. This evidence-
based determination may permit FDA to approve new drug applications for the
combination product doxylamine/vitamin B6."
Dr. Scialli added that "NVP has become such an important issue in the
United States that the National Institute of Child Health and Human
Development has convened a group of experts to discuss this issue during a
special conference which will take place on September 20th and 21st."