Archive for September, 2010

Democrats unveil global drug safety bill

U.S. inspections of overseas pharmaceutical plants would increase and regulators would gain new recall power under proposals unveiled by Democrats in the House of Representatives on Monday. Representatives Henry Waxman, Frank Pallone, John Dingell and Bart Stupak said they released the measures to open discussion on ways to help the Food and Drug Administration better police the increasingly global marketplace for prescription drugs.

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U.S. warns Bristol Myers over Puerto Rico plant

U.S. health regulators have warned Bristol Myers Squibb Co (BMY.N) over repeated manufacturing violations at its facility in Puerto Rico and said future drug approvals could be at risk, according to a letter released on Tuesday. The problems, which include failures to take steps to prevent contamination or investigate subpar drug batches, show inherent weakness with the company’s quality controls, the Food and Drug Administration said in a letter to Bristol Chairman and Chief Executive Jim Cornelius.

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Study Sees Heart Risk in Meridia Diet Pill

A clinical trial of Meridia, a controversial diet pill, in nearly 10,000 overweight or obese older patients over many years found that the drug increased the risks of heart attacks and strokes while doing little to slim their waists. The study was paid for by Abbott Laboratories, Meridia’s maker, and published in The New England Journal of Medicine. The authors of the study concluded that the trial results did little more than show that patients with heart problems should not be prescribed Meridia.

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