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Public Citizen Petitions FDA To Add Black-Box Warning On Impotence Drugs
Erectile Dysfunction Drugs Viagra, Cialis, and Levitra Linked to NAION Vision Loss In mid-October 2005 the consumer-advocacy group Public Citizen petitioned the FDA to add a "black-box" warning to the labels of Pfizer Inc.’s…
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After Two-year Search, FDA Names New Director For Office of Drug Safety
FDA Scientist Gerald Dal Pan Will Be Director of FDA Drug-Safety Office In October 2005 the FDA named staff scientist Gerald Dal Pan its new director of the agency’s Office of Drug Safety. This…
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FDA Wants Longer Studies Done Before Approving New Psychiatric Drugs
Will The FDA Stand Its Ground Against Big Pharma On This Change In Course? Leila Abboud and Anna Wilde Mathews, of The Wall Street Journal ("WSJ"), reported on October 18, 2005 that the FDA…
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Eli Lilly Sends “Dear Doctor” Letter Regarding Cymbalta and Liver Injury
FDA Warning: Cymbalta May Cause Liver Damage For Patients With Chronic Liver Disease On October 17, 2005 the FDA and Eli Lilly & Co. said in a MedWatch drug alert that the antidepressant Cymbalta…
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FDA To Hold Two-Day Direct-To-Consumer Advertising Meeting In November 2005
Public Meeting to Review Rules Concerning Prescription Drug DTC Advertisements The FDA is considering revising rules about, first, how much side-effect risk information prescription drug commercials must include and, second, whether all direct-to-consumer ("DTC")…
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1500 New Vioxx Lawsuits Filed Against Merck Since Late August
3,481 NJ Vioxx Cases, 2625 MDL Cases, 450 "Others": October 2005 AP Report Reporter Linda A. Johnson, through the Associated Press ("AP"), informed us on October 13, 2005 that Merck now faces more than…
