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.
While physicians can prescribe drugs for uses beyond those approved by the U.S. Food and Drug Administration, pharmaceutical companies can't promote the drugs for those purposes, the Associated Press reported.
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Non-prescription Zyrtec-D Approved by FDA
The U.S. Food and Drug Administration approved on Friday the allergy drug Zyrtec-D for non-prescription use in people 12 and older. It combines the antihistamine Zyrtec with a nasal decongestant.
Zyrtec-D (cetirizine hydrochloride/pseudoephedrine) has been sold as a prescription drug since 2001. Sold by McNeil Consumer Healthcare, it's prescribed for relief of allergy symptoms, including runny nose, sneezing, itchy eyes and nose, and nasal congestion.
Zyrtec-D also is used for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring freer breathing through the nose.
Hay fever and other allergies are the sixth-leading cause of chronic disease, with about 50 million sufferers each year in the United States, according to the U.S. National Institute of Allergy and Infectious Diseases.
"The approval of this widely used drug for nonprescription use will enable many people to have access to another effective treatment for their allergy symptoms," Dr. Andrea Leonard-Segal, director of the FDA's Division of Nonprescription Clinical Evaluation, said in a prepared statement.
Common side effects of Zyrtec-D include drowsiness and dry mouth, the FDA said.
Because the drug contains pseudoephedrine, it is subject to sales restrictions imposed by the federal Combat Methamphetamine Epidemic Act, passed in 2005. These restrictions include limiting the amount that a person can buy, and tracking requirements imposed on stores distributing the product, the FDA said.
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U.S. Stores Ordered to Remove Aqua Dots
| U.S. stores have been ordered to remove Chinese-made Aqua Dots toys from their shelves because they contain a chemical that can turn into the dangerous "date rape" drug gammahydroxybutyrate (GHB) when ingested, the federal Consumer Product Safety Commission said. Aqua Dots are beads that can be arranged into designs that hold together when the beads are sprayed with water. At least two children in the United States and four children in Australia have been hospitalized after swallowing the beads, the Associated Press reported. An investigation has revealed that the toys were coated with harmful 1,4-butanediol -- widely used in plastics and cleaners -- instead of the specified 1,5-pentanediol, a nontoxic compound found in glue. |  |
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
| Two more recalls of Chinese-made toys and products with dangerous levels of lead have been announced by the U.S. Consumer Product Safety Commission. One recall involves 51,000 yellow children's sunglasses distributed by Dolgencorp Inc., of Goodlettsville, Tenn. The other recall involves 175,000 Curious George plush dolls distributed by Marvel Toys of New York City. The recalled 12-inch Curious George dolls are dressed to represent five themes: birthday, fireman, sweet dreams, tool time, and tool time with a soft face. The dolls were sold with a Curious George storybook or activity book at U.S. toy and discount department stores from December 2005 through August 2007. |  |
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.
Three separate reviews of research this year offered "sufficient evidence" of a link between smoking and TB, said Karen Slama, an expert with the International Union Against Tuberculosis and Lung Disease.
"Probably more than 20 percent of the global TB burden may be attributable to smoking," she told journalists at an international lung health conference Cape Town, South Africa. "Smoking may increase the risk by about 20 percent of either getting infected, getting the disease, or dying."
There's also evidence of a significant link between secondhand smoke and TB infection, AFP reported.
"Among people infected with TB, effective tobacco control can lower the number of people that go from (latent) infection to disease ... and death," Slama said. "Tobacco control can also reduce the pool of people that have TB. You can save millions of dollars in TB treatment costs."
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