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Novantrone: FDA MedWatch Alert Regarding Heart Damage Risks
April 2005 "Dear Doctor" Letter Also Addressed an Increased Risk of AML In late May 2005 the FDA warned patients of the risk of heart damage from Serono’s multiple sclerosis drug Novantrone. In a…
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Pfizer Maintains There is No NAION / Blindness Risk from Viagra
Bayer Has Not Decided Whether to Add NAION Warning for Levitra On June 27, 2005 Pfizer Inc. issued a press release asserting that there is no evidence of any increased risk of developing non-arteritic…
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European Drug Regulators Want Increased Warnings on All COX-2 Inhibitor Drugs
Bextra: Suspension of Marketing in European Union to Continue In a June 27, 2005 press release issued by the European Medicines Agency (EMEA), the Agency’s Committee for Medicinal Products for Human Use (CHMP) said…
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Congressman Henry Waxman’s June 2005 NEJM Article About Vioxx and Merck’s Sales Tactics
Tells How Merck’s Drug Reps Did Their Vioxx "Spin" for Concerned Doctors In the June 23, 2005 issue of The New England Journal of Medicine (NEJM), is "The Lessons of Vioxx — Drug Safety…
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Possible Vioxx “Smoking-gun” Document Provides Basis for June 2005 AP Report
Internal Document: Merck Reportedly Considered Changing Vioxx Drug Formulation in 2000 On June 23, 2005 Theresa Agovino and The Associated Press (AP) reported that in 2000 Merck & Co.’s researchers considered reformulating Vioxx in…
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Drug Watch: FDA’s New Early-warning System Web Site
Emerging Side-effect Risk Alerts to be Posted by FDA Online In May 2005 the FDA announced the establishment of a new web site, called Drug Watch, which will serve as the FDA’s new online…
