Health Highlights: Nov. 10, 2007
Mar. 23 -- Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
FDA Approves Products That Reduce Spread of Dangerous Bacteria
The spread of the deadly strain of staphylococcus bacterium known as MRSA away from hospitals and into schools and the general population has prompted the U.S. government to speed up the approval process of products designed to combat the antibiotic-resistant germ.
The Chicago Tribune reports that Deerfield Ill.-based Baxter International has announced U.S. Food and Drug Administration approval of an IV connection tube coated with an antimicrobial substance to prevent bacteria from entering the blood stream.
The FDA has established more streamlined procedures in the approval process, the newspaper reports. "This is becoming more of an issue, so we are developing guidance on it so when manufacturers submit information on their device it is appropriate information for the types of things we want to look at," the Tribune quotes William Maloney, an FDA reviewing physicist, as saying.
Maloney was involved in assessing an infection-resistant tube that would allow easier breathing for pneumonia patients. The tube, developed by C.R. Bard Inc. of Murray Hill, N.J., also received FDA approval las week.
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Drug Maker Reaches Settlement Over Off-Label Marketing Practices
While the decision by pharmaceutical Giant Merck & Co. to pay almost $5 billion to settle thousands of claims over whether the company's pain relief drug Vioxx caused heart damage, a smaller but nonetheless significant settlement was reached last week in a dispute between the U.S. government and Cephalon Inc., which makes sleep and pain drugs.
According to the Bloomberg News service, Cephalon, headquartered in Frazer, Pa., has announced it would plead guilty to one misdemeanor charge and pay $425 million to settle a federal investigation into its sales and marketing practices.
The criminal charge stems from a federal investigation into how Cephalon was promoting "off-label" sales and marketing practices for three of its drugs, Gabitril -- used to treat epilepsy-- narcolepsy drug Provigil and Actiq, which is marketed to relieve cancer pain. The government was also investigating whether Cephalon was attempting to delay generic drug competition, Bloomberg News said.
In 1999, the U.S. Food and Drug Administration declared 1,4-butanediol a class I health hazard because it can cause life-threatening harm, the AP reported.
Aqua Dots, made at a factory in China's Guangdong province, were sold in 40 countries, the wire service said.
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Lead Concerns Prompt Recalls of More Chinese Toys
The yellow sunglasses (no other colors are included in the recall) have the word "China" printed on the left side of the frame. The UPC #400007860896 and words "Fashion Sunglasses" and "Time to Play Every Day" are printed on the product's red hangtag. The glasses were sold at Dollar General stores across the United States from March 2005 through October 2007 for $1.
Consumers should immediately take the sunglasses and dolls away from children, the CPSC said.
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Smoking Plays Role in TB
A number of studies suggest that smoking may be a factor in about one-fifth of tuberculosis infections and deaths worldwide, Agence France-Presse reported.
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