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SOURCE:    Andrew A. Skolnick

Special To The Post-Dispatch PUBLICATION: St. Louis Post-Dispatch

DATE: March 30, 2000

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.

The 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 immediate treatment.

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.

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.

"Self-medication 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?

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.

Industry isn't regulated

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.

Manufacturers back labeling

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.

His 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 pregnant women.

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 labeling.

"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.

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.

Herbs and miscarriage

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: www.genetics.missouri.edu/motis

* Angelica (Angelica archangelica)

* Arbor vitae (Thuja occidentalis)

* Bai Zhi (Angelica dahurica)

* Black cohosh (Cimicifuga racemosa)

* Blue cohosh (Caulophyllum thalictroides)

* Buchu (Barosma betulina)

* Devil's claw (Harpagophytum procumbens)

* German chamomile (Chamomilla recutita)

* Ginseng (Panax ginseng)

* Goldenseal (Hydrastis canadensis)

* Juniper (Juniper communis)

* Licorice (Glycyrrhiza glabra)

* Motherwort (Leonurus cardiaca)

* Myrrh (Commiphora molmol)

* Pennyroyal (Mentha pulegium)

* Prickly ash (Zanthoxylum americanum)

* Senna (Cassia senna)

* Shepherd's purse (Capsella bursa-pastoris)

* Vervain/Ma Bian Cao (Verbena officianalis)

* Yarrow (Achillea millefolium)

* Yellow dock (Rumex crispus)


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