Author Affiliation: Public Citizen's Health Research Group, Washington, DC.
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.
Wolfe SM. Early Signals of Harmful Drugs: Comment on “Potential Safety Signals and Their Significance”. Arch Intern Med. 2012;172(1):73–74. doi:10.1001/archinternmed.2011.544
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