Generic Bupropion Antidepressant Safe, Effective: FDA
Teva Pharmaceuticals' version of generic bupropion extended-release tablets (marketed as Budeprion XL 300 milligram) is a safe and effective choice for the treatment of depression and meets all requirements for approval, the U.S. Food and Drug Administration said Wednesday.
The FDA launched an evaluation of the drug after it received reports of loss of antidepressant effect and new or worsening side effects in some patients who switched from the brand-name drug, Wellbutrin XL, made by GlaxoSmithKline.
The FDA reviewed adverse event reports and other data on the drug, made by Impax Laboratories of California and distributed by Teva, in order to assess its safety and effectiveness.
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Low-Calorie Diet May Protect Against Skin Cancer
A low-calorie diet may help prevent skin cancer, a U.S. study of mice suggests.
Researchers concluded that eating fewer calories prevented activation of two signaling pathways associated with the growth and development of cancer, while a high-calorie diet activated the pathways, CBC News reported.
The study was presented Tuesday at the annual meeting of the American Association for Cancer Research, in San Diego.
"These results, while tested in a mouse model of skin cancer, are broadly applicable to epithelial cancers in other tissues," said senior author John DiGiovanni, director of the department of carcinogenesis at the University of Texas M.D. Anderson Cancer Center, CBC News reported.
The mice in the study had precancerous skin lesions called papillomas and were fed four different diets. Two groups of mice ate calorie-reduced diets (15 percent and 30 percent) while the two other groups ate diets in which 10 percent and 60 percent of calories came from fat.
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Western Rider Push Toys and S'morestick Kits Recalled
About 9,000 Western Rider push toys are being recalled in the United States because surface paint on the toys contains excessive levels of lead, the Associated Press reported.
The Chinese-made toys were imported by Santa's Toy Corp. and sold at dollar and discount stores across the country between February 2005 and February 2008, the U.S. Consumer Product Safety Commission said. There have been no reports of illnesses. For more information phone 800-638-2772.
Another recall involves S'morestick Kits with chocolate pieces that contain milk that's not listed as an ingredient on the packaging. This could pose a health hazard for people with milk allergies. Grand Carnival L.L.C. has received one report of an allergic reaction, the AP reported.
The kits, sold in clear, plastic tubs with a "use by" date of 2/14/09, were distributed to Garden Ridge stores in Florida, Texas, Kentucky, Missouri, Tennessee, Oklahoma, North Carolina, South Carolina, Georgia, Illinois, Ohio, Virginia, Arkansas, Michigan, and Indiana. For more information, phone 877-305-3382.
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South Korea Declares Nationwide Bird Flu Alert
In response to a number of bird flu outbreaks since early April, the South Korean government on Wednesday issued a nationwide bird flu alert, Agence France-Presse reported. Troops have been deployed and firefighters put on standby as part of the effort to try to contain the spread of the disease.
There have been 20 confirmed outbreaks involving the H5 virus and the deadly H5N1 virus has been confirmed as the cause of at least six of them. The agriculture ministry is investigating 14 more suspected outbreaks of bird flu. There have been no reports of human infections.
So far, 2.2 million chickens and ducks have been slaughtered in and around infected farms, mainly in the South and North Jeolla provinces, AFP reported.
Troops are helping to cull chickens and ducks and are manning checkpoints to control movements in areas with reported infections. Firefighters have been told to be ready to help disinfect vehicles and farms or do other tasks.
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Heparin Contaminant May Have Been Added to Boost Profits: FDA
Batches of Baxter International Inc.'s blood thinner heparin may have been intentionally contaminated to increase profit, U.S. Food and Drug Administration Commissioner Dr. Andrew von Eschenbach suggested at a Senate hearing Tuesday.
"It was apparently, we suspect, done by virtue of economic fraud," he told a Senate Appropriations subcommittee that oversees FDA spending, Bloomberg news reported. However, after the hearing, von Eschenbach said his comments may have gone too far and noted that the FDA has no evidence the contamination was deliberate.
Since January 2007, 62 people have died due to allergic reactions or low blood pressure after receiving Baxter's heparin. Some samples of the company's heparin -- in which the main ingredient is made from pig intestines and imported from China -- were contaminated with a cheaper substance derived from animal cartilage.
The FDA hasn't pinpointed where in the supply chain the contaminant was added, but Baxter has said it appears to have occurred before the product reached the company's supplier, Bloomberg reported.
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Bisphenol A May Be Linked to Hormonal Problems: Report
The chemical bisphenol A, used in a wide range of consumer products including baby bottles, may be linked to a number of hormonal problems, says a preliminary report released Tuesday by the U.S. National Toxicology Program, the Associated Press reported.
When rats were fed or injected with low doses of the chemical, they developed precancerous tumors, urinary tract problems and early puberty, the report said. While these findings are based on tests with rats, the possible effects on humans "cannot be dismissed," said the group, which includes scientists from the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health.
A final version of the report will be released this summer. Some environmental groups said the findings confirmed their concerns, while chemical companies continued to insist bisphenol A is safe, the AP reported.
According to the CDC, more than 90 percent of Americans are exposed to trace amounts of the chemical, which leaches out of the linings of cans and other products made with it.
Last summer, a team of researchers assembled by the National Institutes of Health called for more research into how bisphenol A may affect humans. Last November, the FDA said there is "no reason at this time to ban or otherwise restrict its use," the AP reported.
Health Canada is looking into the health risks of bisphenol A and is expected to release its findings within the next few days.
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Suicides Halt Psychiatric Admissions to VA Hospital in Dallas
After four suicides so far this year, the VA Medical Center in Dallas has stopped admitting patients to its 51-bed psychiatric unit, the Fort Worth Star-Telegram reported.
The decision was made by Joe Dalpiaz, director of the Veterans Affairs Department's North Texas medical system. The decision was made "to give us an opportunity to stand down and reassess the environment and the processes in place," said Dr. Catherine Orsak, the hospital's associate chief of staff for mental health.
Dalpiaz "has been very vocal that this is not an assumption that there is blame to find or that (the suicides) could have been prevented. But it is an opportunity to look at things without the demands of an active inpatient unit," Orsak told the Star-Telegram.
Officials at VA headquarters in Washington, D.C., have started examining patient records and are scheduled to visit the psychiatric unit next week. The unit, which currently has nine patients, will refer new patients to the VA hospital in Waco and to private hospitals.
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