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 Todayreported.
"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 Todayreported.
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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.
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UN Targets Pneumonia Deaths
About $39 billion is needed over the next six years in order to greatly reduce pneumonia deaths among children, United Nations officials said Monday, the first World Pneumonia Day.
Pneumonia kills more children than AIDS, malaria and measles combined. UNICEF and the World Health Organization released a plan to save more than 5 million children from dying of pneumonia by 2015, the Associated Press reported.
Pneumonia accounts for about 20 percent of all child deaths worldwide every year, while AIDS causes about 2 percent of child deaths.
The new program features strategies ranging from vaccination to economic development efforts. There's a strong link between malnutrition and poverty and pneumonia deaths.
"This is very simply the biggest killer people never hear about," Orin Levine, a public health expert at Johns Hopkins Bloomberg School of Health, who has advised WHO and UNICEF, told the AP. But Levine added that "this is a big problem that can be solved."
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Domestic Pig's Genome Decoded
Scientists who decoded the DNA of the domestic pig say their achievement may help efforts to develop a new swine flu vaccine for pigs and also may prove useful in developing a variety of treatments for pigs and humans.
People and pigs are similar in size and makeup, and pigs are used in many kinds of human research, ranging from skin disorders and obesity to heart disease, theAssociated Press reported.
"The pig is the ideal animal to look at lifestyle and health issues in the United States," said team leader Larry Schook, a professor of biomedical science at the University of Illinois in Champaign.
The research was presented Monday at a meeting at the Wellcome Trust Sanger Institute in England, which was one of the groups involved in the international effort to document the genome of a red-haired Duroc pig, one of five major breeds used in pork production worldwide, the AP reported.
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