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Vioxx: VIGOR Study Article: NEJM – Merck Controversy Continues
Study Authors Defend Their Research But NEJM Editors Are Not Convinced In the March 16, 2006 edition of The New England Journal of Medicine (NEJM) are two letters by authors of the…
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Drug Safety Oversight Board Needs Improvements, Says Leading FDA Adviser
Chairman Dr. Peter Gross Suggests Two Changes: Open Meetings And Public Representatives In mid-February 2006 Dr. Peter Gross, the outgoing chairman of the FDA’s drug-safety and risk-management advisory committee, said that the agency’s relatively…
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FDA Review Team: Stronger Warnings About Psychosis And Mania Needed On ADHD Drugs
Reports Of Hallucinations At Usual Doses Of Adderall, Concerta, Ritalin, and Strattera The FDA’s ADHD psychiatric review team is calling for stronger warnings on drugs used to treat attention deficit hyperactivity disorder (ADHD) to…
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Health Canada Issues Pregnancy Warning For Antidepressants
Newborns Whose Mothers Took SSRIs At Increased Risk Of Serious Lung Disorder On March 10, 2006 Health Canada issued a warning for women taking antidepressant drugs known as Selective Serotonin Re-uptake Inhibitors (SSRIs) —…
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Pfizer’s Painkiller Celebrex May Increase Heart Attack Risk, Like Vioxx and Bextra
New Zealand Study Indicates This Increased Risk Is "Class Effect" of COX-2 Inhibitors Pfizer Inc.’s painkiller Celebrex doubles a patient’s risk of having a heart attack, according to a report about a New Zealand…
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GlaxoSmithKline Will Revise “Black-box” Warning On Its Asthma Drugs Advair And Serevent
Novartis, However, Continues To Disagree With FDA About The Need To Change Label On Foradil GlaxoSmithKline has finally agreed with the FDA to revise a "black-box" warning on its asthma medications Advair and Serevent…