Copyright 2000 St. Louis Post-Dispatch, Inc. St. Louis Post-Dispatch (Missouri)
March 30, 2000, Thursday, FIVE STAR LIFT EDITION
SECTION: NEWS, Pg. A1
LENGTH: 1204 words
HEADLINE: HEALTH AUTHORITIES PROTEST MARKETING OF UNTESTED REMEDIES TO PREGNANT WOMEN
BYLINE: Andrew A. Skolnick; Special To The Post-Dispatch
Morning sickness is a "common condition" of pregnancy, not a disease.
that may not sound particularly controversial, when the Food and Drug
Administration made that ruling earlier this year, it opened the door
to the marketing to pregnant women of remedies not clinically tested
That's a very bad idea, say
organizations such as the March of Dimes Birth Defects Foundation, the
Centers for Disease Control and Prevention and other health
authorities. They are urging the food and drug agency to rethink its
ruling, which they warn may lead to many more birth defects and other
serious health consequences.
is hearing comments today at a public meeting in Gaithersburg, Md.,
about whether it should revoke or revise its ruling, which went
into effect Feb. 7.
While conditions such
as nausea and leg swelling may be normal for many women during
pregnancy, say maternal health experts, they also may be signs of a
serious illness that needs immediate treatment.
legs in pregnancy could be a sign of preeclampsia, or toxemia of
pregnancy, which if left untreated could cripple or kill the mother or
Likewise, morning sickness is
seldom a serious health problem. But severe nausea and vomiting can
lead to dehydration and other problems that put the fetus and mother at
risk of injury or death.
that alleviates such symptoms can mask a disease process, delay a
woman's seeking medical attention and delay diagnosis by her
physician," said Dr. Donald R. Mattison, medical director of the March
of Dimes, in a summary of the comments he will deliver today.
Invitation to disaster?
these conditions to self-treatment with unproven remedies is an
invitation to disaster, says Sidney M. Wolfe, director of the
Washington-based Public Citizen's Health Research Group. The well-known
dangers of many herbal products for pregnant women should have been
sufficient to prevent the food and drug agency from issuing its
"reckless" regulation, he said.
letter last month to agency commissioner Dr. Jane Henney, he and Dr.
Godfrey Oakley, former director of the Centers for Disease Control's
Division of Birth Defects and Developmental Disabilities, recalled how
the food and drug agency had "saved hundreds if not thousands of
babies" from being born with severe birth defects. Nearly 40 years ago,
the agency st ubbornly resisted pressure to allow the "safe" sleeping
pill thalidomide to be sold in the United States.
simply cannot believe that the agency has really considered the
consequences of this aspect of the final rule," wrote Wolfe and Oakley,
who is now visiting professor of epidemiology at Emory University in
Industry isn't regulated
major reason for alarm, say critics, is that the herbal and dietary
supplement industry is unregulated. The Dietary Supplement Health and
Education Act,, enacted in 1994, bars the food and drug agency from
regulating products promoted as dietary supplements. As a result,
makers of these products do not have to prove their safety or efficacy
- as long as they don't promote them for treating "disease."
that cause birth defects are called teratogens. One of the leadi ng
experts on teratogens is Dr. Thomas H. Shepard, emeritus professor of
pediatrics at the University of Washington at Seattle.
of the things about teratogens is they're full of surprises," says
Shepard. "We're always surprised by substances we thought were safe
which turn out to cause birth defects."
thousands of years, alcohol was used by pregnant women, often for
treating illnesses. In the 1970s, scientists discovered that drinking
alcohol during pregnancy not only can cause severe birth defects, it is
the leading cause of preventable mental retardation, he said.
Manufacturers back labeling
the scheduled speakers today who represent the herbal and dietary
supplement industry is Dr. R. William Soller, senior vice president of
Consumer Healthcare Products Association. The Washington-based trade
organization represents more than 200 members across the manufacturing,
distribution, supply, research testing and advertising sectors of the
self-care industry, says Soller.
association is asking the food and drug agency to require mandatory
labeling similar to the voluntary labeling program his member groups
have recently agreed to follow regarding products that may be used by
One of the proposed labels would state: "If you are pregnant or nursing a baby, ask a health professional."
Michael D. Maves, president of the association, said in a recent
statement that most association members are already providing such
"Our members wanted to go one
step further and formalize this voluntary program to encourage all
manufacturers to provide pregnant and nursing mothers with important
information," he said.
In addition to
using the voluntary language, member companies are also agreeing not to
make product claims related to swelling or edema associated with
pregnancy, Maves added.
labeling is needed for many herbal and dietary supplements, says
Shepard. Many pregnant women unwittingly are exposing themselves and
their babies to unnecessary hazards. For example, vitamin A in large
quantities may cause malformed hearts, brain damage and other birth
The FDA requires the labels of
drugs similar to vitamin A, such as the acne medication Acutane, to
warn women who may be pregnant not to take them.
such labeling is required on vitamin A supplements. Although the
minimum amount of vitamin A that can cause birth defects has not been
established, animal studies suggest that pregnant women should not take
more than 5000 units of vitamin A supplement a day. Yet, capsules
containing 25,000 units are widely sold without any warning on the
Herbs and miscarriage
the following is by no means a comprehensive list, it contains many
herbs known or reputed to cause miscarriage. In addition, if an herb is
not on this list, it is not necessarily safe to take during pregnancy,
says the Missouri Teratogen Information Service, which provided the
More information can be obtained by
calling 800-645-6164 or visiting the information service's Web site: