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- 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."
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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.
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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.
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Recalled Ground Beef Possibly Tied to Two Deaths
Fresh ground beef that was recalled because of possible E. coli contamination may be linked with two deaths and 26 illnesses, according to a U.S. Centers for Disease Control and Prevention official.
The recall includes nearly 546,000 pounds of fresh ground beef distributed by Ashville, N.Y.-based Fairbank Farms to stores from Maine to North Carolina. The ground beef was sold in a number of forms, from hamburger patties to meatloaf and meatball mix, the Associated Press reported.
One death involved a New York adult with several underlying health conditions, said Lola Scott Russell of the CDC. The other death was in New Hampshire, where a patient died from complications, according to state health officials.
The strain of E. coli that prompted the recall is 0157:H7, which infects about 70,000 Americans a year and kills 52, Russell told the AP.
The U.S. Department of Agriculture said customers with concerns should contact the stores where they buy their meat.
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Chronic Stress Triggers Bad Eating Habits: Study
Women under chronic stress are more likely to eat high-fat foods and to feel they lack control over their hunger and eating, say U.S. researchers who asked more than 600 overweight and obese women about their eating habits and the stress in their lives.
The University of California-San Francisco study also found that participants under chronic stress were more likely to rely on "rigid restraint" -- such as skipping meals and vowing to avoid fattening foods -- as a form of weight control, USA Today reported.
"We know from other research that these techniques tend to backfire and people end up overeating and gaining weight," said Elissa Epel, associate professor in the psychiatry department.
The study was presented at a recent meeting of the Obesity Society.
"Chronic stress really taxes people's ability to self-monitor their eating behavior. In our current environment of abundantly rich food, we need every ounce of conscious effort to manage our eating, because eating is an automatic behavior we can do too easily and too often if we're not mindful," Epel said, USA Today reported.
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Second Successful Trial for Lupus Drug
An experimental lupus drug called Benlysta (belimumab) was effective in its second large clinical trial, and drug makers Human Genome Sciences and GlaxoSmithKline will seek European and U.S. approval of the drug in the first half of 2010.
If approved, Benlysta would be the first new treatment for lupus in more than 40 years, The New York Times reported.
Benlysta succeeded in its first clinical trial in July. But the U.S. Food and Drug Administration said a second successful trial was needed in order to win approval for the drug. While the second trial was successful, the results weren't as good as in the first trial.
"The lupus community has waited for decades for one positive phase three trial of an investigative drug developed for lupus. Now we have two," Dr. Joan T. Merrill, a lupus expert at the Oklahoma Medical Research Foundation and investigator in the trial, said in a news release issued by Human Genome Sciences and GlaxoSmithKline, The Times reported.
Copyright © 2009 ScoutNews LLC. All rights reserved.
Published on: 11/03/2009
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