Category: Off-label Use / Prescribing
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Scios Says Two Deaths In Natrecor Trial Were Not Reported To FDA
Latest Natrecor News Increases Safety Concerns About J&J Heart Failure Drug The Scios unit of Johnson & Johnson (J&J) did not immediately report to the FDA two deaths from a clinical trial, or study,…
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“iPLEDGE” Registry for Accutane Patients Is Mandatory Starting In 2006
Primary Aim Is To Reduce Number Of Accutane-related Birth Defects Enrollment in the "iPLEDGE’ national registry for the anti-acne drug Accutane is mandatory starting January 1, 2006. This "iPLEDGE" registry concerns any and all…
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FDA’s David Graham Says U.S. Drug Safety System No Better in 2005
Graham Criticizes Agency’s Performance During The Year Since Vioxx Recall In November 2004 David Graham, associate director for science and medicine at the FDA’s Office of Drug Safety, criticized the FDA’s drug oversight practices…
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FDA Warns MS Patients Not to Use Leukemia Drug Campath
Reports of Severe Blood Disorder ITP In 3 Campath – MS Study Patients On November 30, 2005 the FDA issued a public health advisory warning against the use of Campath in patients with multiple…
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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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Controversy Over Safety of Heart Failure Drug Natrecor Continues
Doubting Its Safety, Dr. Eric Topol and Others Want Natrecor Recalled In the October 6, 2005 issue of The New England Journal of Medicine ("NEJM") appears a letter to the editor by Jonathan Sackner-Bernstein,…
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Scios / J&J to Educate Doctors Regarding Which Patients Should, and Should Not, Receive Natrecor
Guidance to Doctors Prompted by Natrecor Expert Panel or US DOJ Investigation of Sales Tactics? Johnson & Johnson’s Scios unit announced on August 22, 2005 the launch of a new program intended to educate…
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Natrecor: Medical Experts Adamant About Their Advice Given to Scios / Johnson & Johnson
Natrecor Advisory Panel Report is Probably Not What Drug Maker Expected, or Wanted In the August 9, 2005 edition of The New York Times, reporter Stephanie Saul succinctly characterized the current Natrecor situation: "Call…
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Johnson & Johnson Attempts to Restrict Prescribing Of Heart-failure Drug Natrecor
Drug Company Warns Doctors Against "Off Label" Use of Natrecor at Clinics Johnson & Johnson is apparently acting on some two-month old advice from an expert panel of cardiologists in attempting to restrict the…
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Scios Sends Second “Dear Doctor” Letter On Heart Drug Natrecor
Cardiologist Eric Topol Calls For Limited Use of Johnson & Johnson Drug Natrecor On July 13, 2005 the Scios division of Johnson & Johnson sent a second "Dear Doctor" letter about Natrecor, a heart-failure…