|HEALTH AUTHORITIES PROTEST
MARKETING OF UNTESTED REMEDIES TO PREGNANT WOMEN
Andrew A. Skolnick
Special To The Post-Dispatch
PUBLICATION: St. Louis Post-Dispatch
March 30, 2000
EDITION: FIVE STAR LIFT
Morning sickness is a "common condition" of pregnancy, not a disease.
While 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 for safety.
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.
agency 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
Swollen legs in pregnancy could be a sign
of preeclampsia, or toxemia of pregnancy, which if left untreated could
cripple or kill the mother or her fetus.
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.
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.
Leaving 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.
In a 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.
"We 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 Atlanta.
A 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."
Agents 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.
"One 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."
For 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.
Among 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."
Dr. 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
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.
Clearly, mandatory 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 defects.
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.
No 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 label.
While 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 list.
More information can be obtained by
calling 800-645-6164 or visiting the information service's Web site:
* Angelica (Angelica
* Arbor vitae (Thuja occidentalis)
Zhi (Angelica dahurica)
* Black cohosh (Cimicifuga racemosa)
* Blue cohosh (Caulophyllum thalictroides)
* Buchu (Barosma
* Devil's claw (Harpagophytum procumbens)
German chamomile (Chamomilla recutita)
* Ginseng (Panax
* Goldenseal (Hydrastis canadensis)
* Licorice (Glycyrrhiza glabra)
Motherwort (Leonurus cardiaca)
* Myrrh (Commiphora molmol)
* Pennyroyal (Mentha pulegium)
* Prickly ash (Zanthoxylum
* Senna (Cassia senna)
* Shepherd's purse
* Vervain/Ma Bian Cao (Verbena
* Yarrow (Achillea millefolium)
dock (Rumex crispus)
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