A literature review of Toxic Shock Syndrome is presented, including epidemiology, etiology, signs, symptoms and management, and its relationship to infection susceptibility in the Down Syndrome patient. A case of a Down Syndrome patient with Toxic Shock Syndrome is described, and the role of odontogenic infection is discussed.

Adolescent↗

PubMedDate not supplied

Osteoporosis: regulatory view.

Evaluation of drugs proposed for the prevention and treatment of osteoporosis is difficult. The Food and Drug Administration (FDA) has issued guidelines for the clinical investigation of drugs in this class. Estrogen has been approved for the treatment of postmenopausal osteoporosis. Administration of estrogen requires careful assessment of the risks and benefits for the individual patient. The smallest effective dose should be used. There are both potential risks and benefits for the concommitant administration of a progestin. Calcitonin has also been approved; however, the need for parenteral administration, the problem of antibody formation, and expense may limit the usefulness of the currently marketed preparations. Calcium has been recommended, but because it is considered a food supplement it has not been submitted to FDA for evaluation of its safety and efficacy as a drug in the treatment of osteoporosis. Other drugs under investigation include anabolic steroids, fluorides, vitamin D substances, biphosphonates, parathyroid hormone, and thiazides.

Calcitonin↗

PubMedDate not supplied

Surgical treatment of thoraco-abdominal aneurysms.

Explore the source record for details and available documents.

Adult↗

PubMedDate not supplied

The role of epidemiology in the regulation of oral contraceptives.

The U.S. Food and Drug Administration (FDA) has relied to a great degree on epidemiologic studies in the regulation of oral contraceptives (OC). These epidemiologic studies range from individual case reports of adverse reactions to case-control studies and cohort studies. Important findings about adverse reactions to OCs have been communicated through "labeling," which includes information leaflets provided as package inserts for physicians and patients. Also, the FDA communicates its position through publications in medical journals, the FDA Drug Bulletin, public advisory committee meetings, workshops, and symposia. The agency responds to new epidemiologic information; labeling guidelines are under continuing review and revision. Patterns of oral contraceptive use have been affected by the dissemination of this information. There has been a decline in the use of OCs, a shift to formulations with lesser steroidal content, and a greater emphasis on OC use in optimal groups, such as young, nonsmoking women. Considered for future epidemiologic studies that may have an impact on regulatory action are a clarification of the role of various progestins in regard to blood lipid alteration and atherogenesis, a delineation of the possible persistence of cardiovascular risk after termination of OC use, and further clarification in regard to neoplasia, particularly breast and cervical carcinoma.

Contraceptives, Oral↗