United States
In 1979, the United States Food and Drug Administration (FDA) introduced a classification of fetal risks due to pharmaceuticals. This was based on a similar system that was introduced in Sweden one year earlier.
The United States FDA has the following definitions for the pregnancy categories:
| United States FDA Pharmaceutical Pregnancy Categories | |
| Pregnancy Category A | Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). |
| Pregnancy Category B | Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. |
| Pregnancy Category C | Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. |
| Pregnancy Category D | There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. |
| Pregnancy Category X | Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. |
| Pregnancy Category N | FDA has not classified this drug. |
One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be considered Pregnancy Category A in other countries are allocated to Category C by the FDA. See below.
The FDA has proposed updating its approach to labeling http://edocket.access.gpo.gov/2008/pdf/E8-11806.pdf
Read more about this topic: Pregnancy Category
Famous quotes related to united states:
“America—rather, the United States—seems to me to be the Jew among the nations. It is resourceful, adaptable, maligned, envied, feared, imposed upon. It is warm-hearted, overfriendly; quick-witted, lavish, colorful; given to extravagant speech and gestures; its people are travelers and wanderers by nature, moving, shifting, restless; swarming in Fords, in ocean liners; craving entertainment; volatile. The schnuckle among the nations of the world.”
—Edna Ferber (1887–1968)
“Vanessa wanted to be a ballerina. Dad had such hopes for her.... Corin was the academically brilliant one, and a fencer of Olympic standard. Everything was expected of them, and they fulfilled all expectations. But I was the one of whom nothing was expected. I remember a game the three of us played. Vanessa was the President of the United States, Corin was the British Prime Minister—and I was the royal dog.”
—Lynn Redgrave (b. 1943)
“Prior to the meeting, there was a prayer. In general, in the United States there was always praying.”
—Friedrich Dürrenmatt (1921–1990)
“To the United States the Third World often takes the form of a black woman who has been made pregnant in a moment of passion and who shows up one day in the reception room on the forty-ninth floor threatening to make a scene. The lawyers pay the woman off; sometimes uniformed guards accompany her to the elevators.”
—Lewis H. Lapham (b. 1935)
“It is said that the British Empire is very large and respectable, and that the United States are a first-rate power. We do not believe that a tide rises and falls behind every man which can float the British Empire like a chip, if he should ever harbor it in his mind.”
—Henry David Thoreau (1817–1862)