Archive for January, 2011

Breast implants linked to rare lymphoma

Federal health officials announced Wednesday that they were investigating a possible association between saline and silicone gel-filled breast implants and a rare form of cancer known as anaplastic large cell lymphoma (ALCL). In a statement released in advance of a briefing for reporters, the FDA said it had found a “a very small but significant risk of ALCL in the scar capsule adjacent to the implant” after reviewing data and was asking doctors to report any cases of ALCL in women with breast implants.

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Tylenol Products Recalled

McNeil Consumer Healthcare, which makes Tylenol pain relief drugs, says it is recalling a number of lots of its Tylenol products as well as some lots of Sinutab, Benadryl, and Sudafed PE because the medications were made at a plant where production was suspended in April 2010. McNeil says in a news release posted on the FDA’s web site that the recalled products were made in a Fort Washington, Pa., plant that was closed because of concerns about equipment cleaning procedures.

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Researchers Say Not Everyone Needs Statins to Prevent Heart Disease

Millions of people take statin drugs to lower their cholesterol levels. And there’s been an even bigger push to use them to prevent heart disease since the cholesterol-busting statin drug Crestor was approved by the U.S. Food and Drug Administration as a way to stave off cardiovascular disease in those who don’t yet have it. But a group of British researchers found that people who are at low risk for heart disease — in this case, those who have never had heart disease and aren’t likely to develop it — may not benefit very much from taking statins.

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Glaxo Sees $3.5 Billion Charge Related to Avandia Claims, Sales Practices

GlaxoSmithKline Plc, the U.K.’s biggest drugmaker, said it will have fourth-quarter legal costs of 2.2 billion pounds ($3.5 billion) because of a U.S. investigation into sales practices for certain products and product-liability cases related to the Avandia diabetes drug. The company is setting aside additional provisions for the investigation by the U.S. attorney in Colorado into the company’s sales and promotional practices of certain products, London-based Glaxo said in an e-mailed statement today.

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Bristol-Myers, Sanofi Recall Hypertension Drug

Bristol-Myers Squibb Co. (BMY) and Sanofi-Aventis SA (SNY) recalled about 64 million tablets of hypertension drug Avalide because a manufacturing problem could affect the drug’s efficacy. It is the second significant recall of Avalide in recent months. In September, Bristol and Sanofi recalled about 60 million tablets.

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FDA orders lowering pain reliever in Vicodin

Federal health regulators are limiting a key ingredient found in Vicodin, Percocet and other prescription painkillers that have been linked to thousands of cases of liver damage each year. The Food and Drug Administration said Thursday it will cap the amount of acetaminophen in the drugs at 325 milligrams per capsule. Current products on the market contain doses of up to 700 milligrams.

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FDA seeks less acetaminophen in prescription drugs

U.S. health regulators are requesting a limit on the amount of acetaminophen in prescription pain medicines in an effort to curb the risk of liver damage. The move announced on on Thursday aims to limit combination drugs such as the opioids Percocet and Vicodin to 325 milligrams of acetaminophen per pill and calls for them to carry a “black box” warning about potential liver failure.

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