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.
Labels on all over-the-counter pain relievers will be required to warn consumers about risks posed by the interaction of heavy alcohol consumption and the use these products, under an FDA rule proposed last November. The products include aspirin, other salicylates, acetaminophen, ibuprofen, ketoprofen, and naproxen sodium. (FR Nov. 14)
The benefits from eating more fruits and vegetables far outweigh any risks from exposure to pesticides, says a panel sponsored by Canada's National Cancer Institute. The panel said using pesticides actually reduces cancer risk by making more fruits and vegetables available at lower prices. (Cancer, December 1997)
A single-dose treatment for pediatric ear infections has received FDA approval. Rocephin (ceftriaxone sodium) is an injectable antibiotic for treating acute otitis media, cited as the most frequent reason for doctor visits by children under 6. The new product is expected to be especially beneficial for children who cannot take oral medications or who have trouble complying with a dosing schedule. Hoffmann-La Roche Inc., of Nutley, N.J., markets Rocephin.
Though some studies suggest that zinc lozenges can reduce the length of a cold, a new analysis of six previous studies says the verdict is still out on zinc's benefits. The analysis says some earlier studies were flawed because it is difficult to produce a dummy tablet that has the same bitter taste as zinc lozenges. As a result, study participants who actually received a zinc tablet may have been tipped off by taste and were, therefore, unable to be objective about the severity of their cold symptoms. (Archives of Internal Medicine, Nov. 12)
The risk of death from heart disease and stroke may increase after eating a high-fat meal because of a significant rise in the body's production of a component called Factor VII, according to a Danish study. An increase in Factor VII can form vessel-blocking blood clots and cause heart attacks or strokes. The study showed that Factor VII levels decreased after a low-fat meal. (Arteriosclerosis, Thrombosis and Vascular Biology, December 1997)
Certain food products marketed as "organically produced" would have to conform to national standards under a U.S. Department of Agriculture proposal. Included is a program that would accredit inspectors to certify that farms and harvesting and handling operations comply with the standards. The deadline for comments on the proposal is March 16. [Editor's Note: USDA has extended the comment period to April 30, 1998.] Write to Eileen Stommes, Room 4007-So., AgStop 0275, P.O. Box 96456, Washington, DC 20090-6456; fax to 202-690-4632; or e-mail through the program's Website at http://www.ams.usda.gov/nop/ (FR Dec. 16)
A vaccine against anthrax bacteria, a deadly biologic agent, will be given to U.S. military personnel beginning this summer. FDA approved the vaccine in 1970. It has traditionally been given to veterinarians and others who work with livestock.
Adverse reactions to drugs or biologic agents affect up to 30 percent of hospitalized patients, according to a study at the University of South Alabama. Researchers also determined that as many as 29 percent of outpatients require hospitalization for adverse drug reactions. Study authors urge physicians to treat adverse reactions immediately and report them to MedWatch, FDA's surveillance system for adverse reactions, at 1-800-FDA-1088. (Journal of the American Medical Association, Dec. 10)
Federal research indicates that 80 percent of girls and 60 percent of boys don't get enough calcium in their teen years to form healthy bone density. So the Department of Health and Human Services has launched an educational program designed to reverse this trend. "A Crash Course on Calcium" includes a video featuring Olympic gold medalists Amy Van Dyken and Kristi Yamaguchi, a teacher's guide, a poster, and a "Clueless About Calcium" brochure that dispels myths such as that all dairy products are fattening. These materials are free to schools through the Website www.vpw.com or by calling 1-800-WHY-MILK.
FDA Consumer magazine (March-April 1998)