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FDA pregnancy categories

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Related terms
Background
Theory/evidence
Safety
Author information
Bibliography
Categories

Related Terms
  • Adequate protein diet, Barry Sears, carbohydrate, diet, fat, low carbohydrate diet, protein.

Background
  • The Zone diet is an unproven dietary regime, which has been popularized by Dr. Barry Sears through sales of his 1995 book, The Zone. Despite claims made in the book, there is little available research to support its overall benefit.
  • The Zone diet is a calorie-restricted diet that provides adequate protein, moderate levels of carbohydrates, essential fats and micronutrients spread through three meals and two snacks that approximately maintain the protein-to-carbohydrate ratio throughout the day.
  • Proponents believe that the Zone diet promotes optimal metabolic efficiency in the body by balancing the hormones insulin and glucagon. Insulin is responsible for converting, in the blood, incoming nutrients into cells. Glucagon regulates glucose in the liver. Overall, the Zone's food plan consists of a dietary intake of 40% carbohydrates, 30% protein and 30% fat.
  • Under this diet, recommended foods include fruits and vegetables (fresh or frozen), oatmeal (whole grain), protein powder (e.g. soybean isolate), chicken, turkey, lean beef, fish, low-fat cottage cheese, soy food, nuts (e.g. almonds, cashews, macademia, pistachios), extra virgin olive oil, natural sweeteners, such as fructose or stevia.

Theory / Evidence
  • Recent research seems to indicate that a low total caloric intake is associated with longer life expectancy. Based on animal studies, animals eating calorie-restricted diets may live 1.5 to 2 times as long as animals eating high-calorie diets. Theoretically, similar effects may occur in humans. The caloric restriction recommended by the Zone diet is below that of the average American and may be of benefit in weight loss and if maintained over decades in increasing life expectancy. On the other hand, athletes in training will likely suffer from decreased performance if restricted to the low calorie diet recommended by the Zone.
  • Despite proposed benefits, currently there are no high quality clinical trials available about the Zone diet or similar diets consisting of the recommended 40% carbohydrates, 30% fat, and 30% protein. The Zone diet is quite complex in terms of caloric restriction, ratio of carbohydrates/protein//fat, spacing of meals, preferential intake of certain fats, and avoidance or inclusion of a few specific foods.

Safety




Author information
  • This information has been edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).

Bibliography
  1. Cheuvront SN. The zone diet and athletic performance. Sports Med. 1999;27(4):213-228.
  2. Natural Standard: The Authority on Integrative Medicine.
  3. Sears B. The Zone Diet and athletic performance. Sports Med. 2000;29(4):289-294.

Categories
  • Category A: Controlled studies in pregnant women fail to demonstrate a risk to the fetus in the first trimester with no evidence of risk in later trimesters. The possibility of fetal harm appears unlikely. Examples may include: folic acid, vitamin B6 and thyroid medicine in moderation or in prescribed doses.
  • Category B: Either animal-reproduction studies have not demonstrated a fetal risk, but there are no controlled studies in pregnant women, OR animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester and there is no evidence of a risk in later trimesters. Examples may include: some antibiotics, acetaminophen (Tylenol), aspartame (artificial sweetener), famotidine (Pepcid), prednisone (cortisone), insulin (for diabetes), and ibuprofin (Advil, Motrin) before the third trimester. Pregnant women should not take ibuprofen during the last three months of pregnancy.
  • Category C: Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal effects or other) and there are no controlled studies in women, OR studies in women and animals are not available. Drugs should be given only if the potential benefits justify the potential risk to the fetus. These drugs may include prochlorperazine (Compazine), Sudafed, fluconazole (Diflucan) and ciprofloxacin (Cipro). Some antidepressants are also included in this group.
  • Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g. if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). Examples may include alcohol, lithium (used to treat manic depression), phenytoin (Dilantin) and most chemotherapy drugs to treat cancer. In some cases, chemotherapy drugs may be given during pregnancy.
  • Category X: Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. Examples may include: drugs to treat skin conditions like cystic acne (Accutane) and psoriasis (Tegison or Soriatane); a sedative (thalidomide); and a drug to prevent miscarriage used up until 1971 in the United States and 1983 in Europe (diethylstilbestrol or DES).

Copyright © 2011 Natural Standard (www.naturalstandard.com)


The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.

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