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Early Signals of Harmful Drugs: Comment on “Potential Safety Signals and Their Significance”

Early Signals of Harmful Drugs: Comment on “Potential Safety Signals and Their Significance” The approval of drugs by the Food and Drug Administration (FDA) is appropriately based on the results of phase 3 clinical trials. Unfortunately, most of these trials are underpowered to detect any but the most commonly occurring adverse events. In the postmarketing phase (phase 4), the FDA relies primarily on submission of adverse reaction reports filed by physicians. To provide this information more rapidly to physicians and consumers so that they could use it to change or stop treatment with medications that might be harmful, recent legislation required the FDA to notify the public about “any new safety information or potential signal of a serious risk” based on recently analyzed adverse reaction reports filed with the agency. An important study1 in this issue of the Archives reveals that the information contained in the reported adverse reactions is of great value. Powers and Cook1 found that 48% of the signals resulted in label changes within 3 years of public notification. Given the value of these reports, it is hard to understand why the FDA warns prescribers and patients against taking any action based on this new information. For most, if not all, of these drugs, alternative (usually older) drugs with comparable efficacy and more established safety records can be found. This emphasizes the importance of using the postmarketing Adverse Event Reporting System (AERS) database in updating safety information following approval. Although the FDA has been advising against using the AERS signals for clinical decisions, they have just announced a new program for “Advancing Regulatory Science at the FDA.”2 There is a discussion in the document about finding new ways for being “better able to identify and accurately predict and reduce the magnitude and likelihood of risks associated with products.”2(p9) Unfortunately, there is no discussion about using currently available safety information in a much more patient-protective way that reduces risks. The study by Powers and Cook1 demonstrates the value of signal data. Now the FDA needs to marshal, not discourage, its use. Back to top Article Information Correspondence: Dr Wolfe, Director, Public Citizen's Health Research Group, 1600 20th St NW, Washington, DC 20009 (swolfe@citizen.org). Published Online: November 14, 2011. doi:10.1001/archinternmed.2011.544 Financial Disclosure: None reported. References 1. Powers A, Cook GE. Potential safety signals and their significance [published online November 14, 2011]. Arch Intern Med. 2012;172(1):72-73Google ScholarCrossref 2. US Food and Drug Administration. Advancing Regulatory Science at FDA. August 2011. http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf. Accessed October 6, 2011 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Internal Medicine American Medical Association

Early Signals of Harmful Drugs: Comment on “Potential Safety Signals and Their Significance”

Archives of Internal Medicine , Volume 172 (1) – Jan 9, 2012

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Publisher
American Medical Association
Copyright
Copyright © 2012 American Medical Association. All Rights Reserved.
ISSN
0003-9926
eISSN
1538-3679
DOI
10.1001/archinternmed.2011.544
Publisher site
See Article on Publisher Site

Abstract

The approval of drugs by the Food and Drug Administration (FDA) is appropriately based on the results of phase 3 clinical trials. Unfortunately, most of these trials are underpowered to detect any but the most commonly occurring adverse events. In the postmarketing phase (phase 4), the FDA relies primarily on submission of adverse reaction reports filed by physicians. To provide this information more rapidly to physicians and consumers so that they could use it to change or stop treatment with medications that might be harmful, recent legislation required the FDA to notify the public about “any new safety information or potential signal of a serious risk” based on recently analyzed adverse reaction reports filed with the agency. An important study1 in this issue of the Archives reveals that the information contained in the reported adverse reactions is of great value. Powers and Cook1 found that 48% of the signals resulted in label changes within 3 years of public notification. Given the value of these reports, it is hard to understand why the FDA warns prescribers and patients against taking any action based on this new information. For most, if not all, of these drugs, alternative (usually older) drugs with comparable efficacy and more established safety records can be found. This emphasizes the importance of using the postmarketing Adverse Event Reporting System (AERS) database in updating safety information following approval. Although the FDA has been advising against using the AERS signals for clinical decisions, they have just announced a new program for “Advancing Regulatory Science at the FDA.”2 There is a discussion in the document about finding new ways for being “better able to identify and accurately predict and reduce the magnitude and likelihood of risks associated with products.”2(p9) Unfortunately, there is no discussion about using currently available safety information in a much more patient-protective way that reduces risks. The study by Powers and Cook1 demonstrates the value of signal data. Now the FDA needs to marshal, not discourage, its use. Back to top Article Information Correspondence: Dr Wolfe, Director, Public Citizen's Health Research Group, 1600 20th St NW, Washington, DC 20009 (swolfe@citizen.org). Published Online: November 14, 2011. doi:10.1001/archinternmed.2011.544 Financial Disclosure: None reported. References 1. Powers A, Cook GE. Potential safety signals and their significance [published online November 14, 2011]. Arch Intern Med. 2012;172(1):72-73Google ScholarCrossref 2. US Food and Drug Administration. Advancing Regulatory Science at FDA. August 2011. http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf. Accessed October 6, 2011

Journal

Archives of Internal MedicineAmerican Medical Association

Published: Jan 9, 2012

References