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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…
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Black-box Warning for Celebrex and Other NSAIDs
FDA Requires Warning Label Changes for Painkillers In June 2005 the FDA advised Pfizer, the maker of Celebrex, and several other drug manufacturers that the package insert, or warning label, for their prescription NSAID…
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FDA’s Drug Safety Oversight Board Holds First Meeting
No Specific Drug-safety Issues Discussed at Board’s First Meeting On June 17, 2005 the FDA’s Drug Safety Oversight Board (DSOB) held its first meeting, the primary purpose of which was to allow the Board…
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Antipsychotic Risperdal Associated with Benign Tumors in Pituitary Gland
Another Possible Side Effect for Atypical Antipsychotic Class of Drugs On June 17, 2005 The Wall Street Journal reported that Risperdal, one of the so-called atypical antipsychotic drugs, has been associated with benign tumors…
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Toxic Epidermal Necrolysis (TEN) is Usually Due to Adverse Drug Reaction
Patients with Toxic Epidermal Necrolysis (TEN) Often Have Fatal Outcome Toxic epidermal necrolysis (TEN) is an infrequent, yet often fatal, severe systemic and cutaneous disease that is most often the result of an adverse…
