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• W4238049720 abstract "To the Editor:I believe that Dr Menendez1Menendez R. “Black box” warnings and drug surveillance.J Allergy Clin Immunol. 2007; 119: 759Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar misinterprets the “black box” warning. The Food and Drug Administration view is that the prescription drug label's (package insert) primary use is to provide essential information that the practitioner needs to use this drug safely and effectively.2Beach J.E. Faich G.A. Bormel F.J. for Hyman, Phelps & MacNamara, P.C., Washington, D.C.Black box warnings in Rx drug labeling: a survey of 206 drugs.Food Drug Law J. 1998; 53: 403-411PubMed Google Scholar, 3Murphy S. Roberts R. “Black box” 101: how the Food and Drug Administration evaluates, communicates, and manages drug benefits/risk.J Allergy Clin Immunol. 2006; 117: 34-39Abstract Full Text Full Text PDF PubMed Scopus (70) Google ScholarThe Food and Drug Administration has established 5 levels of cautionary information of which the black box is the highest level warning of potentially severe adverse effects. The “black box” warnings for long-acting β-agonists and topical inhibitors make it clear there is sufficient information of potential adverse events to raise concern about safety, but insufficient information to support removal from the market. The black box is there, hopefully, to ensure the physician becomes aware of the potential risk and the literature reporting these potential risks. The physician is responsible for informing the patient of the risks and benefits of a drug, but the ultimate decider of whether or not to take a drug is the patient or their surrogate.In carrying out this responsibility, the physician needs to assess the significance of evidence suggesting there is or is not a significant risk. The black box is an attention getter to help ensure physicians are aware of the potential risk and pass that information on to the patient. The black box raises questions. We physicians need to assess these questions as best as we can. Patients are entitled to know what we know (or should know) in language they can understand.Dr Menendez would like prospective drug surveillance. We do not have time to wait for that to become a useful reality. We have an obligation today to ensure our patients are aware of what we know relative to drug safety. That includes their becoming aware that our information is not necessarily clear one way or the other. The patient needs to make a decision whether to take a drug or not. The black box is for patient protection, and, in this imperfect world, it seems to do its job as well as anything could. To the Editor: I believe that Dr Menendez1Menendez R. “Black box” warnings and drug surveillance.J Allergy Clin Immunol. 2007; 119: 759Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar misinterprets the “black box” warning. The Food and Drug Administration view is that the prescription drug label's (package insert) primary use is to provide essential information that the practitioner needs to use this drug safely and effectively.2Beach J.E. Faich G.A. Bormel F.J. for Hyman, Phelps & MacNamara, P.C., Washington, D.C.Black box warnings in Rx drug labeling: a survey of 206 drugs.Food Drug Law J. 1998; 53: 403-411PubMed Google Scholar, 3Murphy S. Roberts R. “Black box” 101: how the Food and Drug Administration evaluates, communicates, and manages drug benefits/risk.J Allergy Clin Immunol. 2006; 117: 34-39Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar The Food and Drug Administration has established 5 levels of cautionary information of which the black box is the highest level warning of potentially severe adverse effects. The “black box” warnings for long-acting β-agonists and topical inhibitors make it clear there is sufficient information of potential adverse events to raise concern about safety, but insufficient information to support removal from the market. The black box is there, hopefully, to ensure the physician becomes aware of the potential risk and the literature reporting these potential risks. The physician is responsible for informing the patient of the risks and benefits of a drug, but the ultimate decider of whether or not to take a drug is the patient or their surrogate. In carrying out this responsibility, the physician needs to assess the significance of evidence suggesting there is or is not a significant risk. The black box is an attention getter to help ensure physicians are aware of the potential risk and pass that information on to the patient. The black box raises questions. We physicians need to assess these questions as best as we can. Patients are entitled to know what we know (or should know) in language they can understand. Dr Menendez would like prospective drug surveillance. We do not have time to wait for that to become a useful reality. We have an obligation today to ensure our patients are aware of what we know relative to drug safety. That includes their becoming aware that our information is not necessarily clear one way or the other. The patient needs to make a decision whether to take a drug or not. The black box is for patient protection, and, in this imperfect world, it seems to do its job as well as anything could." @default.
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• W4238049720 date "2007-03-01" @default.
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• W4238049720 title "Reply" @default.
• W4238049720 doi "https://doi.org/10.1016/j.jaci.2007.01.013" @default.
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