Herbal Supplements & Pregnancy

By Donald Mattison, MD.

Safety Concerns for Health Care Providers

Today more than 60 million Americans are medicating themselves with herbal supplements. This amounts to $3 to 4 billion a year in out-of-pocket expense. By assuming that "natural" remedies are safe, your patients are probably not fully discussing the issue with you, if at all. Research shows that many do not see the need to inform their physicians of their use of alternative medicine including herbal supplements.

This is a serious issue, since "natural" does not always mean "safe," says Dr. Jan Friedman. In the case of herbal supplements, "natural" really means "unregulated" (Jan Friedman FDA testimony ). As medical director of the March of Dimes, I have grave concerns about the safety of herbal products with regard to the health of fetuses and infants.

Few studies have been conducted testing herbal preparations in pregnancy. Some of these products, including sassafras, borage and comfrey have ingredients suspected of causing hepatic failure and have carcinogenic potential. Some, such as St. John"s Wort have been shown to decrease the effectiveness of birth control pills or to interfere with medication such as HIV drugs. Other herbs may pose a special risk to pregnant women and their fetuses.

A national survey by National Public Radio, the Kaiser Family Foundation and Harvard's Kennedy School of government finds that half of all Americans believe that dietary supplements other than standard minerals and vitamins are generally good for their health and well-being. There are about 400 herbs used widely and distributed as capsules, extract, tablets and teas. While many of these dietary supplements are safe, there are some very hazardous ones. In fact, over the last twenty years, at least 100 people have died due to the effects of these supposedly "safe" substances.

Since herbal products are considered dietary supplements by the Food and Drug Administration (FDA), they are not regulated by that agency as are traditional drugs. The manufacturers of these products are not required to demonstrate the safety and effectiveness of their products before they reach the market. In addition, they do not have to adhere to any of the standard quality controls used for drugs. As a result, the composition of herbal products may vary greatly from one batch to another. Some herbal products have been contaminated with lead or other substances that could pose a risk in pregnancy. Under its current regulatory authority, the FDA can remove an herbal supplement from the market only after it has been shown to be unsafe.

In May 2000, researchers at the University of Arkansas published their study results concerning ephedra supplements sold as a decongestant, energy booster or diet aid. They found significant differences between what the label said and the actual contents in half the samples examined. Discrepancy between label and contents in some cases was as much as 20 percent. One product contained no ephedra alkaloids and at least one sample contained potentially dangerous amounts of ephedra with 154 percent of what the label listed. Dr. William J. Gurley, the lead researcher, said that poor quality may contribute to problems associated with safety and efficacy of herbal supplements. Ephedra has been linked to hundreds of adverse reactions and several deaths, as further revealed in a study by Drs. Christine Haller and Neal Benowtiz from the University of California in San Francisco that reviewed 140 reports of adverse events submitted to the FDA.

The National Institutes of Health"s National Center for Complementary and Alternative Medicine (NCCAM) is currently studying the safety and effectiveness of a number of herbal remedies. The results of these studies should help clarify who can benefit from these products.

But until then, there is special concern for patients about the safety of herbal products used during pregnancy and lactation. Many herbal supplements stimulate uterine contractions, which may increase the risk of miscarriage or premature labor. Some of these include: blue cohosh (used to treat menstrual cramps), juniper (used for heartburn), pennyroyal or rosemary (used for digestive problems), sage (used for stomach upset), and thuja (used for respiratory infections). One laboratory suggests that raspberry tea, commonly used to treat morning sickness, may also cause uterine contractions, so pregnant women should also avoid this remedy. Only one of these herbal substances, ginger, actually has been studied in pregnant women and appears to be helpful . The March of Dimes has always advised pregnant women to consult their health care provider before taking any herbal supplement, prescription or over-the counter medication.

In March, 2000, the March of Dimes urged the FDA not to allow the makers of herbal products and other dietary supplements to promote these products as remedies for pregnancy-related conditions, such as morning sickness and leg swelling.

In testimony provided at the FDA hearing, the March of Dimes noted that in a small but significant percentage of pregnant women, conditions such as nausea and vomiting or leg edema are symptoms of disease processes that can seriously endanger the mothers and fetuses. Women cannot be expected to know when their symptoms have crossed the line from normal discomfort to disease state. Self-medication that alleviates symptoms could give a woman a false sense of security and delay her from seeking an appropriate diagnosis and treatment from her physician.

The hearing was called by the FDA after it decided to reconsider its January 6, 2000 ruling to classify morning sickness and leg swelling in pregnancy as "common conditions associated with natural states or processes." This classification would permit the makers of herbal products to market their products as treatment for these conditions.

As medical director of the March of Dimes, I have grave concerns about the safety of herbal products with regard to the health of fetuses and infants. There has not been enough animal or human testing to demonstrate whether these products cause birth defects or represent other serious hazards to mothers and their babies. They are best avoided during pregnancy and breastfeeding.

When a pregnant woman is suffering from pregnancy-related discomforts or other ills, she should not assume that it is safe to take an herbal remedy. She should discuss her symptoms with her health care provider who can recommend the safest possible treatment.

Health care providers need to initiate a dialogue with their patients about herbal supplements to obtain a complete health history and to take advantage of the opportunity to make patients aware that all that is "natural" may not be safe.

Special Dietary Guidelines for Teenage Pregnancy

There are Recommended Dietary Allowances, or RDAs, for teenagers and for women nursing a baby. But should there be special nutritional guidelines for teenage mothers who are nursing? Some preliminary research suggests it might be a good idea.

Pediatrician Kathleen Motil, who is with the US Agricultural Research Service's Children's Nutrition Research Center in Houston, Texas, compared the milk production of 22 mothers--half teens, half adults. The nutrient compositions were similar, but the teens produced 37 to 54 percent less milk than adults. Motil's findings were published last summer in the Journal of Adolescent Health.

Motil said the differences between adult and teen milk production remained statistically significant, even after she adjusted the data for differences in feeding time and daily nursing frequency. Why should the milk volume be different? Motil has a theory.

"Our preliminary observations suggest that teenage mothers are facing a dual metabolic challenge," said Motil. "It may be they are still growing, themselves, which may cause an extra nutritional demand."

Motil and her colleagues wanted to find out more about teen nutrition during lactation. They measured body composition, dietary intakes, and milk production. The participants: 24 teenage mothers, half of whom breast-fed their infants. Eleven additional teens who had never been pregnant served as a control group. Barbara Kertz, patient service coordinator at the nutrition research center, organized the study.

Preliminary findings suggest that teenagers who nurse their infants continue to add muscle mass to their bodies, indicating ongoing growth.

"We found that nursing teens consumed more energy (calories), protein, and vitamin B6 than teen mothers who bottle-fed or teens who never had children," says Kertz. "They were taking in 23 percent more calories and vitamin B6 and 40 percent more protein." The teens' intake returned to regular levels after weaning. This research team also included nutritionist Corinne Montandon, who helped the girls keep a food journal to track the amounts and kinds of foods they ate. Montandon reviewed the journals for accuracy and sometimes provided a little advice. She cautioned one mother, for example, against trying to crash diet her way back to a pre-pregnancy figure.

Encouraging Breast-Feeding After Pregnancy

Knowing about teenagers' nutritional demands during breast-feeding fits into a bigger plan of encouraging all mothers to breast-feed--regardless of age. In fact, USDA's Food and Nutrition Service (FNS) has started a nationwide campaign to encourage breast-feeding.

The number of U.S. teenagers becoming pregnant has been declining, but many groups estimate half a million girls under 20 do give birth annually. For those who choose to raise their infants, breast-feeding can offer advantages such as protection against a broad range of infections and enhanced bonding.

Teenagers are less likely to chose breast-feeding than adults, however. During an FNS focus group on breast-feeding, women of all ages cited embarrassment and lack of family support as barriers to breast-feeding.

But teens face special problems, according to a survey by Alain Joffe, M.D., of the Department of Pediatrics at Johns Hopkins University Hospital. Joffe has studied breast-feeding among 250 inner city teens in Baltimore, Maryland. Susan Radius, a sociologist at nearby Towson University, was a co-author.

The researchers found teenage mothers who returned to high school had a hard time working nursing into their schedule.

Joffe said in his survey the best indicator of whether a teen would breast-feed successfully was having a breast-feeding mentor. That person could be her mother, aunt, or other older friend who had breast-fed successfully and could provide advice.

He added that for teens to accept breast-feeding they must know the benefits and feel confident about ways of dealing with obstacles. Some high schools, for example, allow new mothers special time to breast-feed.

Breast-feeding advice and public acceptance seem a long way from research. But these outside factors can have very real effects on the science. If fact, the researchers have to account for the extent of their teenage subjects' breast-feeding knowledge. That's why Kertz, a lactation consultant, met with the girls in their study from delivery onward, to provide breast-feeding basics.

Still, the researchers at the Houston center don't know exactly how the teens handled their breast-feeding before their study began. Theresa O. Scholl, who is with the University of Medicine and Dentistry of New Jersey, read Motil's paper on breast milk production. Scholl's career has focused on the effects of teen pregnancy and lactation on the health of girls and their infants.

"The differences between the growing teens and adult women in this study are huge. It's really impressive," says Scholl. "It might be good to do a follow-up study of the infants from birth to the first 6 months. That way, you could find out if the teen mothers were offering to nurse less often from the start and if that contributed to a reduction in milk flow."

Kertz agrees that the study's findings, like all scientific research, open the door to new questions.

"Breast-feeding is an issue of supply and demand," she says. "The more a mother breast-feeds, the more milk she'll have and the longer she'll be able to nurse. Most of the girls weaned their infants at 3 to 4 months. Was this an arbitrary decision to stop nursing, or did the young mothers lack the nutrients to continue?"

There are bigger questions, however--the most basic one being how real is the competition between growing teens and their infants for nutrients? Another is: Do the girls really continue to grow during their childbearing and nursing? Medical textbooks once said no; now the question is being revisited.

Scholl points to her studies of pregnant teens that measured growth of the lower leg only, rather than from head to foot. Lordosis, a natural bending of the spine during pregnancy, can cause errors in a head-to-foot measurement. These studies suggested strongly that growth continues during pregnancy.

Does it follow that continued growth in teens could affect breast milk volume? Scholl points out that, during pregnancy at least, nature often favors the mother during nutrient stress. Studies on famine and infant birth weight have suggested this natural advantage may have contributed to the survival of the human species.

"Nature wouldn't allow the mother to deplete all her resources," says Scholl. "If it did, she couldn't live to bear more offspring. Moreover, if the mother died, what would happen to her baby?"

More research will need to be done to say with certainty that teen growth causes nutrient competition that results in lower birth weights in newborns and less milk during lactation. But Scholl's work on teen births and Motil's work on teen nursing lend support to the theory that the body puts some of its nutrients on reserve to benefit the teenage mother.

If this proves to be true, physicians will want to be sure that teenage mothers are getting the extra nutrition they and their infants need to ensure breast-feeding success. - ByJill Lee, Agricultural Research Service Information Staff, 6303 Ivy Lane, Greenbelt, Maryland 20770, phone (301) 344-2781.

Source: USDA-ARS Children's Nutrition Research Center, Baylor College of Medicine.

Herbs Contraindicated in Pregnancy

Source: The Complete German Commission E Monographs, Therapeutic Guide to Herbal Medicines, Blumenthal, Busse, Goldberg, Gruenwald, Hall, Klein, Riggins and Rister, The American Botanical Council, Austin, Texas, Published in cooperation with Integrative Medicine Communications, Boston, Massachusetts, 1998.

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Donald Mattison

Author Donald Mattison, MD writes for the March of Dimes Foundation. For more information about the safe use of herbs during pregnancy see March of Dimes Foundation.




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