Statement by Doris Haire, President of the AmericanFoundation for Maternal and Child Health, New York tothe FDA Science Board November 17, 2000 I appreciate this invitation to share my concerns with the members of the FDA Science Board, and to ask the Board to urge the FDA to create an Interdisciplinary Obstetric Advisory Board comprised…
Author: birthtopics
USEFUL DEFINITIONS
The following definitions may be helpful when reading the package inserts of the drugs discussed in this web site. Acidosis: abnormal balance of cerebral oxygen (a pathologic condition in blood gases whereby there is accumulation of acid and hydrogen ions in the blood and tissues, decreasing the pH.) Afibrinogenemia: deficiency or absence of fibrinogen (coagulating factor in…
DRUGS NOT FDA APPROVED FOR OBSTETRICS
There have been no adequate and well-controlled studies to determine the delayed, long-term effects of the drugs listed below on pregnant women or on the neurologic, as well as general, development of children exposed to the drugs in utero or during lactation. Such use is defined by the FDA as “off-label” use. Following is a…
FDA APPROVED OBSTETRICS DRUGS: THEIR EFFECTS ON MOTHER AND BABY
© 2001 Doris Haire, President, American Foundation for Maternal and Child Health and Chair, Committee on Maternal and Child Health, National Women’s Health Alliance FDA USES ITS OWN DEFINITION OF SAFE Most Americans, including many health care providers, assume that if the FDA approves a drug for marketing then the FDA has determined that drug…
JUST HOW SAFE IS “SAFE”? How the F.D.A. Determines The “Safety” of Drugs
FEW AMERICANS REALIZE THAT: The approval of a drug by the U.S. Food and Drug Administration (FDA) does not mean that the FDA has approved the drug for general use. The FDA approves specific doses for the treatment of specific illnesses and conditions. Many health care providers, including doctors and nurses, have not been taught…
The WORLD HEALTH ORGANIZATION report, “CARE IN NORMAL BIRTH: A Practical Guide”
Following are the recommendations appearing on pages 34-37 of the Report: CLASSIFICATION OF PRACTICES IN NORMAL BIRTH, WHO This chapter classifies the practices common in the conduct of normal childbirth into four categories, dependent on their usefulness, effectiveness and harmfulness. The classification reflects the views of the Technical Working Group on Normal Birth. Arguments for…