| The "black box" warning and allergy drugs. | |
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MedLine Citation:
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PMID: 16387582 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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In the past years, several drugs commonly used by allergy specialists have received a "black box" warning added to their package insert at the direction of the Food and Drug Administration (FDA). A "black box" warning is the highest level of 5 possible warning categories found in the package insert. The FDA has never articulated the basis for "black box" warnings. They generally appear to be based on clinical data, but occasionally can be based on serious animal toxicity. In the last several years, several drugs commonly used by allergists have received recommendations for "black box" warnings. Long-acting beta-agonists (salmeterol and formoterol) received "black box" warnings because of reports of the occurrences of severe asthma exacerbations in some patients with asthma, with some associated death. Topical calcineurin inhibitors (tacrolimus and pimecrolimus) received a recommendation for application of a "black box" warnings because of a possible increase of cancer developing in patients taking these drugs. Although the addition of a "black box" warning was recommended by the FDA Pediatric Advisory Committee for these 2 topical agents, the FDA has not yet implemented this warning. Informed consent principles require that a patient be adequately informed of the risks (among other components) of any recommended treatment. The risks, as described, of the long-acting beta-agonists and topical immunosuppressants should be presented to the patients to aid them in deciding whether they are willing to take these drugs when recommended by their physician. |
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Authors:
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Donald W Aaronson |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: The Journal of allergy and clinical immunology Volume: 117 ISSN: 0091-6749 ISO Abbreviation: J. Allergy Clin. Immunol. Publication Date: 2006 Jan |
Date Detail:
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Created Date: 2006-01-02 Completed Date: 2006-02-09 Revised Date: 2008-11-21 |
Medline Journal Info:
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Nlm Unique ID: 1275002 Medline TA: J Allergy Clin Immunol Country: United States |
Other Details:
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Languages: eng Pagination: 40-4 Citation Subset: AIM; IM |
Affiliation:
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Finch University School of Health Sciences, Chicago Medical School, Chicago, IL 60657, USA. doclaw@post.harvard.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adrenergic beta-Agonists
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adverse effects* Albuterol / adverse effects, analogs & derivatives Calcineurin / antagonists & inhibitors* Drug Labeling* Ethanolamines / adverse effects Humans Hypersensitivity / drug therapy* Immunosuppressive Agents / adverse effects* Informed Consent United States United States Food and Drug Administration* |
| Chemical | |
Reg. No./Substance:
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0/Adrenergic beta-Agonists; 0/Ethanolamines; 0/Immunosuppressive Agents; 18559-94-9/Albuterol; 73573-87-2/formoterol; 89365-50-4/salmeterol; EC 3.1.3.16/Calcineurin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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