Category: “Dear Doctor” Letters
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Anti-Cancer Drug Herceptin Associated With Significant Risk of Cardiotoxicity
Genentech Says Its Breast Cancer Drug Can Increase Risk of Heart Problems The FDA and Genentech, Inc. have warned healthcare professionals by means of an August 2005 "Dear Doctor" letter of study data linking…
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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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Psoriasis Drug Raptiva Increases the Risk of Serious Infections
July 2005 "Dear Doctor" Letter Warns About Some Blood Disorders, Also Genentech Inc. and the FDA announced recently that the drug company had added a new warning for the psoriasis drug Raptiva about an…
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Duragesic Pain Patch: Johnson & Johnson Adds Warning to Label and Sends “Dear Doctor” Letter
FDA Follows With Public Health Advisory on Duragesic and Other Fentanyl Patches On July 8, 2005 Johnson & Johnson Inc. added warnings about possible misuse and abuse to its Duragesic pain patch package insert…
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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…
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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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Natrecor “Dear Doctor” Letter Seeks to Address Recent Safety Concerns
Letter Includes New Natrecor Label Revised in April 2005 Natrecor is a treatment, administered by injection, for patients with acutely decompensated congestive heart failure (ADHF) with dyspnea. Recent reports in medical journals have raised…