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Biogen and FDA Warn of Severe Skin Reactions To Lymphoma Drug Zevalin
Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), and Erythema Multiforme (EM) In late October 2005 Biogen Idec Inc. and the FDA warned doctors about severe and sometimes fatal skin reactions that have been reported…
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New Jersey / NJ Vioxx Trial: Humeston Case Goes to Jury After Closing Arguments
Humeston v. Merck Verdict: Will The Jury Weigh In For The Plaintiff or Defense? Today, after a seven-week trial, a New Jersey state court jury in the Humeston v. Merck Vioxx case should hear…
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FDA Probably Will Not Require Longer Studies Of New Psychiatric Drugs
Advisory Panel Rejects FDA Proposal: Good Idea, But Wrong Approach In late October 2005 an FDA advisory panel rejected the agency’s recent proposal that would have required the drug companies to do longer-term studies…
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“Off-label” Prescribing of Psychosis Drugs For Alzheimer’s Has Risks
Careful Consideration Needed When Prescribing Zyprexa or Risperdal for Alzheimer’s-related Dementia Elderly patients with Alzheimer’s disease who are prescribed antipsychotic drugs such as Zyprexa and Risperdal have a higher risk of dying than patients…
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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…
