 |
 |
|
|
|
| |
March of Dimes Urges FDA to Ban Pregnancy-Related Health Claims on Herbal Products
WASHINGTON, DC, MARCH 30, 2000 -- The March of Dimes today urged the Food and Drug Administration not to allow the makers of herbal products and most other dietary supplements to promote these products as remedies for pregnancy-related conditions such as morning sickness or leg swelling.
"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 their fetuses," said Donald R. Mattison, M.D., medical director of the March of Dimes, speaking at an FDA public meeting.
The hearing was called by FDA after it decided to reconsider its January 6 ruling to classify morning sickness and leg swelling in pregnancy as being among many "common conditions associated with natural states or processes."
The March of Dimes wants this ruling reversed, Dr. Mattison said. He said pregnancy is a unique condition involving nine months of very complex changes in the mother's body. Although morning sickness and leg swelling are a normal part of pregnancy, he said, sometimes they indicate serious complications such as dehydration, preeclampsia (toxemia of pregnancy), kidney failure, liver disease, or severe dietary protein deficiency.
"Women cannot be expected to know when their symptoms have crossed the line from normal discomfort into a disease state," said Dr. Mattison. "Self-medication to alleviate these symptoms could give a woman a false sense of security and delay her from seeking a proper diagnosis and care from her physician."
The March of Dimes has a long-standing policy advising pregnant women not to take any prescription or over-the-counter medication without first consulting their physicians.
Herbal products and dietary supplements cannot claim to prevent or cure disease without prior FDA review. Multivitamins containing the B vitamin folic acid are permitted to state that it can help prevent serious birth defects of the brain and spine known as neural tube defects. The March of Dimes recommends that all women of childbearing age take a daily multivitamin with folic acid as part of a healthy diet.
Dr. Mattison said the March of Dimes has grave concerns about the safety of herbal products and most other dietary supplements for the health of fetuses and infants. "There has not been enough animal or human testing to demonstrate whether or not these products cause birth defects or other serious hazards to babies -- they are best avoided during pregnancy and breastfeeding," he said.
|
|
|
| |
|
|
|
|
