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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…
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Drug-induced Rhabdomyolysis and Acute Renal Failure (ARF) Cases On Increase
Rhabdomyolysis is Result of Skeletal Muscle Injury Caused by Drugs (and Other Things) The number of drug-induced rhabdomyolysis adverse event reports submitted to the FDA is rising, seemingly due to the introduction to market…
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Lilly Plans to Settle Most Zyprexa Legal Cases for $690 Million
Zyprexa Lawsuits Alleged Failure to Warn About Diabetes Side Effect Risk In the first part of June 2005, Eli Lilly & Co. said it had reached an agreement with certain groups of plaintiffs’ lawyers…
