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GlaxoSmithKline to Defend Paxil in Birth-Defect Case

GlaxoSmithKline Plc, the world’s second-biggest drugmaker, begins a trial in Philadelphia in what may be a test case for more than 600 lawsuits over claims its antidepressant drug Paxil causes birth defects. Patients and their parents claim internal company documents produced for trial show Glaxo failed to warn about the…

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FDA Requires Strong Amputation Warning on Promethazine

Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, the Food and Drug Administration said Wednesday. The drug, previously sold by Wyeth Pharmaceuticals Inc. under…

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Glaxo Withheld Paxil Birth-Defect Data, Witness Says

GlaxoSmithKline Plc, the world’s second-biggest drugmaker, withheld birth-defect data tied to its antidepressant drug Paxil from physicians as the number of reports grew, a psychiatrist testified. Doctors seeking information about birth defects linked to Paxil originally got the total numbers of side-effect reports about the issue from Glaxo, Dr. David…

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Glaxo Executive’s Memo Suggested Burying Drug Studies

An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial. “If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would…

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Glaxo E-Mails Over Paxil Study Must Be Turned Over

GlaxoSmithKline Plc’s e-mail with researchers studying birth defects allegedly caused by the drugmaker’s antidepressant Paxil must be turned over to a family suing over the drug. U.S. District Judge Nancy Gertner in Boston refused to block William Seale’s family from reviewing e-mails and other communications between Glaxo and Boston University…

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FDA Warns Bayer Maker of Yaz and Yasmin

U.S. health regulators have warned drugmaker Bayer over quality control issues at a plant that makes the key ingredient in Yaz and other popular birth control drugs. In a warning letter posted online Tuesday, the Food and Drug Administration said its inspectors uncovered testing problems at the company’s plant in…

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Utah Supreme Court Says Insurer Has to Pay Malpractice Policy

After years of legal wrangling, a 12-year-old Eureka, Utah boy who suffered brain damage at birth is a step closer to getting money to help compensate for his injuries. The Utah Supreme Court on Tuesday ruled an insurance company cannot invalidate the medical malpractice policy of the obstetrician who made…

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