- Cereal's 'Immunity' Claim Outrages Experts
- FDA Rejects Cholesterol Drug Application
- Diabetes Drug Label to Address Safety Concerns: FDA
- Recalled Ground Beef Possibly Tied to Two Deaths
- Chronic Stress Triggers Bad Eating Habits: Study
- Second Successful Trial for Lupus Drug
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
Cereal's 'Immunity' Claim Outrages Experts
Health and nutrition experts are attacking Kellogg for claims that one of its cereals benefits children's immune systems because it contains increased levels of vitamins A, C and E.
Bold lettering on the front of Cocoa Krispies boxes claims the cereal "Now helps support your child's IMMUNITY," a declaration likely to catch the eye of parents worried about the danger the H1N1 virus presents to their children.
"The idea that eating Cocoa Krispies will keep a kid from getting swine flu, or from catching a cold, doesn't make sense," Marion Nestle, a nutrition professor at New York University, told USA Today. "Yes, these nutrients are involved in immunity, but I can't think of a nutrient that isn't involved in the immune system."
After she saw the cereal box claims in August, she sent a letter to the U.S. Food and Drug Administration, which has jurisdiction over false or misleading labeling. Nestle hasn't heard back from the agency.
Many others are outraged by the marketing tactic. The City of San Francisco sent a letter to the FDA asking that it make Kellogg prove its claim, USA Today reported.
The claim "was not created to capitalize on the current H1N1 flu situation," said Kellogg spokeswoman Susanne Norwitz. The cereal was developed "in response to consumers expressing a need for more positive nutrition."
FDA Rejects Cholesterol Drug Application
An application for a new cholesterol pill that combines Lipitor and Zetia has been rejected by the U.S. Food and Drug Administration because it wants more information about the manufacturing and stability of the combination drug.
The unusual decision was disclosed Monday by Merck & Co., which applied to the FDA in September for approval of the two-drug pill, the Associated Press reported. Lipitor and Zetia are approved for sale in the United States.
The FDA may only have minor questions about details of test results, or agency staff may have "found something they don't like," Steve Brozak, president of WBB Securities, told the AP.
Usually, the FDA accepts applications for experimental drugs and then reviews the extensive data that accompanies the applications. Information about how often applications are rejected up front wasn't immediately available.
"We do intend to refile" with additional data, Merck spokesman Ron Rogers told the AP.
Diabetes Drug Label to Address Safety Concerns: FDA
A drug used to treat type 2 diabetes, Byetta, may contribute to kidney malfunction, the U.S. Food and Drug Administration warned Monday as it moved to revise safety information on the label.
Over a three-year period, the FDA received 78 reports of kidney problems, including kidney failure, among patients using Byetta, it said in a statement. Some of the patients had pre-existing kidney disease, while others were at risk of developing kidney disease.
"Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems," said Dr. Amy Egan, of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research. "Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back."
Patients with any of these symptoms should notify their physician right away.
Because of the safety concerns, the FDA is working with drug make Eli Lilly and Co. to update prescribing information on the label.
Altered kidney function, which causes waste products to build up in the blood, can lead to serious or life-threatening conditions.