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The Notebook: a potpourri of items of interest gathered from FDA news releases, other news sources, and the Federal Register (designated FR, with date of publication). The Federal Register is available in many public libraries. It is also available electronically through GPO Access at the Government Printing Office.
Over-the-counter drug products containing silver-based ingredients are not generally recognized as safe and are misbranded, according to an FDA proposed rule. Many of these products are marketed for treating serious diseases such as AIDS, cancer, tuberculosis, and malaria. But the agency is not aware of scientific evidence that supports silver-based ingredients as disease treatment. Written comments on the proposed rule must be submitted by Jan. 13, 1997, to the Dockets Management Branch (HFA-305), FDA, Room 1-23, 12420 Parklawn Drive, Rockville, MD 20857. (FR Oct. 15)
A report on conjugated estrogens, used for estrogen replacement in women, is available free from FDA. The agency recently sought public comment on its preliminary analysis of the Premarin brand of conjugated estrogens to help decide which components should be included in the generic version of Premarin. "Preliminary Analysis of Scientific Data on the Composition of Conjugated Estrogens" (a 692k PDF file) is available on the World Wide Web at www.fda.gov/cder/; the document is also available through "fax on demand" at (1-800) 342-2722.
Conditions in cattle such as gastrointestinal roundworms, lungworms, eyeworms, grubs, lice, and mange mites may be treated with Dectomax (doramectin) 1% solution, says an FDA final rule. Cattle are not to be slaughtered within 35 days of treatment, and the product is not for use in dairy calves 20 months or older or in calves to be processed for veal. (FR Oct. 11)
A genetically engineered mouse that should boost understanding of Alzheimer's disease and ultimately allow for testing of drug therapies has been developed by University of Minnesota researchers. The mouse is the first to exhibit both behavioral characteristics of Alzheimer's dementia and protein-derived plaques like those in the brains of people with the disease. (Science, Oct. 4)
Children's test scores appear to improve when youngsters eat breakfast close to test time, according to Israeli research. A study examined 569 children, aged 11 to 13, of varying socioeconomic backgrounds. While eating breakfast two hours before a test did not appear to improve the children's cognitive functions, test scores improved significantly when children ate breakfast just half an hour before a test. (Archives of Pediatrics and Adolescent Medicine, October 1996)
Depression may increase a woman's risk for broken bones, suggests a National Institute of Mental Health study. Researchers found the hip bone density of women with a history of depression to be 10 to 15 percent lower than normal for their age--so low that their risk of hip fracture increased by 40 percent over 10 years. Excess cortisol secretion, a common feature of some forms of depression, is known to cause bone loss and could account for some of the observed deficits, the researchers say. (New England Journal of Medicine, Oct. 17)
FDA Consumer magazine (January-February 1997)