Merck to Pay $4.85 Billion To Settle Vioxx Suits
U.S. pharmaceutical maker Merck & Co. will pay $4.85 billion to settle 27,000 lawsuits from plaintiffs who said they or family members were injured or died after taking Merck's pain medication Vioxx, The New York Times and other media reported Friday.
Merck halted sales of Vioxx in September 2004 after a study showed the drug increased users' risks of heart attack and stroke.
The deal is believed to be the largest drug settlement ever, the Associated Press reported. It would only become binding if 85 percent of all plaintiffs agreed to abandon their lawsuits and accepted the deal, the Times said.
Among the criteria needed to qualify for a portion of the settlement, litigants must have filed a claim by Nov. 8, 2007, provided medical proof of heart attack or stroke, and proof that they received at least 30 Vioxx pills, the AP reported.
Different settlement payments would be given to plaintiffs based on the severity of injury and the length of time a patient took Vioxx. It's expected that the average plaintiff would receive about $100,000, before legal fees and expenses, which usually consume 30 to 50 percent of a payment, the newspaper said.
Plaintiffs who don't accept the deal can continue to pursue their lawsuits against Merck.
Over the past two years, Merck has contested nearly 20 Vioxx civil trials across the country. The drug maker lost a $253 million verdict in the first case, but has won most of the other lawsuits. The company's annual Vioxx-related legal fees are running at more than $600 million a year, The Times 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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Most U.S. Children Don't Have Yearly Dental Checkup
In 2004, only 45 percent of Americans 20 or younger said they saw a dentist once a year or more, even though the American Academy of Pediatric Dentistry recommends most young people get at least two checkups a year, according to 2004 national survey data from the U.S. Agency for Healthcare Research and Quality.
The 2004 dental checkup rate was only slightly better than in 1996, when 42 percent of children had at least one dental exam a year.
Other findings from the 2004 survey:
- Only 31 percent of children from low-income families saw a dentist once a year, compared with 47 percent of children from middle-income families, and 62 percent of children from high-income homes.
- Only 33 percent of Hispanic children and 34 percent of black children saw a dentist each year, compared with 53 percent of white children.
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New Breathing Tube Reduces Pneumonia Risk
A breathing tube coated with a thin layer of silver that reduces the risk of pneumonia for hospital patients on ventilators has been approved by the U.S. Food and Drug Administration. Silver is known to have anti-microbial properties.
The Agento endotracheal tube, made by C.R. Bard Inc. of Murray Hill, N.J., is intended for use in patients who have to use a ventilator to breathe for 24 hours or more, said the FDA, which announced the device's approval Thursday.
Patients who have to stay on ventilators for long periods are at risk of exposure to hospital-acquired bacteria that can build up on the breathing tube or pass through to their lungs. This may result in ventilator-associated pneumonia (VAP).
VAP develops in about 15 percent of patients on ventilators and kills about 26,000 patients a year in the United States, according to the Centers for Disease Control and Prevention.
A clinical trial found that pneumonia developed in about 4.8 percent of patients using the Agento breathing tube, compared with 7.5 percent of patients using an uncoated tube.
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