Archive for March, 2010

Infantino Baby Slings Recalled in U.S., Canada After 3 Infants Died

On the heels of a warning that baby slings can kill infants, Infantino LLC has recalled 1 million of the products in the U.S. and 15,000 in Canada. At least three children died in these slings in 2009: a 7-week-old in Philadelphia, a 6-day old infant in Salem, Ore., and a 3-month-old in Cincinnati. Infantino is recalling two popular brands of the slings: the “Wendy Bellissimo” sold exclusively at Babies ‘R’ Us; and the “SlingRider” sold at Walmart, Burlington Coat Factory, Target, BJ’s Wholesale, and other stores since January 2003.

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FDA Tells Doctors To Temporarily Stop Using Rotarix

The Food and Drug Administration recommended Monday that doctors temporarily stop using GlaxoSmithKline PLC’s (GSK) Rotarix child vaccine after a virus was found in the product. The agency said it needed to learn more about parts of an extraneous virus that was found in the vaccine. Rotarix, approved for use in the U.S. in 2008, is typically given to babies at two and four months of age and is designed to help protect infants from a gastrointestinal illness caused by rotavirus.

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Cleviprex hypertension drug recall expanded

Medicines Co. expanded a voluntary recall of hypertension drug Cleviprex on Wednesday because of metal gunk in some vials. They could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues or cause inflammation. Reduced blood supply to tissues may lead to organ insufficiency in the brain, kidney, liver, heart or lungs. The drug’s manufacturer. is recalling another four lots of the drug, after it recalled 11 lots in December.

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FDA Rejects Amylin Diabetes Drug Byetta, Seeks More Info

The U.S. Food and Drug Administration denied approval of a long-acting version of diabetes drug Byetta, sold by Amylin Pharmaceuticals Inc. and Eli Lilly & Co., because the agency needs more information about the drug’s product label, risk-management plan and manufacturing process. The drug–commonly referred to as Byetta LAR, with a proposed brand name of Bydureon–is injected once a week as opposed to the twice-daily version on the market. It faces heavy competition in the diabetes market and the timing of its launch is seen as crucial to its eventual success.

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Plavix gets new FDA warning

The Food and Drug Administration said it was adding a new boxed warning to Plavix, an $8-billion-a-year drug sold by Bristol-Myers Squibb Co and Sanofi-Aventis SA. The new language will “warn about reduced effectiveness in patients who are poor metabolizers of Plavix,” the FDA said in a notice on its website. Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with heart disease by making platelets less likely to form blood clots.

Hissey Kientz announced launch of online legal documents database

The law firm of Hissey Kientz, LLP is pleased to announce the addition to its website of a new legal documents database containing medical studies, case law and other legal documents. The database will provide a resource for attorneys and clients concerning the firm’s practice areas, including mesothelioma and asbestos cases, the Duragesic or fentanyl pain patch and Fleet Phospho-soda. Continue reading ‘Hissey Kientz announced launch of online legal documents database’

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