Archive for December, 2011

FDA advisers: Ortho Evra patch needs clearer label

U.S. drug advisers recommended that the label for Johnson and Johnson’s Ortho Evra birth control patch be simplified to better explain the risk of blood clots. Advisers to the Food and Drug Administration found that the current label for Ortho Evra inadequately reflects the risks women face by using it. The patch, approved in 2001, has been linked to an even higher risk as it contains a much greater amount of the hormone estrogen than a pill.

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The High Cost of Failing Artificial Hips

The most widespread medical implant failure in decades — involving thousands of all-metal artificial hips that need to be replaced prematurely — has entered the money phase. Medical and legal experts estimate the hip failures may cost taxpayers, insurers, employers and others billions of dollars in coming years, contributing to the soaring cost of health care. One troubled all-metal model, implanted in 40,000 patients in the United States, was recalled last year by the DePuy division of Johnson & Johnson. As of October, some 3,500 patients had filed a lawsuit involving that device.

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FDA Further Restricts Use of Sanofi’s Multaq

The Food and Drug Administration further restricted the recommended use of the heart-rhythm drug Multaq, which has been linked to an increased risk of death among some groups of patients. The safety agency’s latest advisory said that patients with a “permanent” version of the abnormal heartbeat called atrial fibrillation shouldn’t get the medicine, generically called dronedarone. The FDA’s safety communication Monday said the drug in those people “doubles the rate of cardiovascular death, stroke and heart failure.”

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GlaxoSmithKline sued over risks associated with Avandia

A St. Tammany Parish resident has filed a lawsuit against GlaxoSmithKline for its alleged failure to warn about risks associated with the antidiabetic drug Avandia. John Anderson took Avandia to treat his diabetes and states that the drug caused eye hemorrhages and a stroke on Aug. 20, 2011.

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McNeil Recall of Motrin® IB Tablets and Caplets

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (McNeil) is voluntarily recalling certain lots of MOTRIN® IB 24 count COATED CAPLETS, MOTRIN® IB 24 count COATED TABLETS and MOTRIN® IB 24+6 count COATED CAPLETS from retailers. McNeil is recalling these products because testing of product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date.

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Liquid Acetaminophen marketed for infants: Drug Safety Communication – Potential for Dosing Errors

The FDA is informing the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available. Giving the wrong dose of acetaminophen can cause the medication to be ineffective if too little is given or cause serious side effects and, possibly, death if too much is given. Acetaminophen is marketed under brand names such as Tylenol, Little Fevers,  Triaminic, Infant/Pain Reliever, Pedia Care, Triaminic Infants’ Syrup Fever Reducer Pain Reliever and other store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.).

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FDA warning on Multaq emphasizes risks for patients with permanent heart irregularity

Federal health officials have added new safety warnings to the heart rhythm drug Multaq after company studies linked the pill to higher rates of heart attack, stroke and death in a subset of patients. The new label, posted online Monday, highlights a study in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation, a condition in which the heart’s chambers pump out of sync.

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