Serious adverse reactions (ADRs) are associated with many drug products. As a corollary to the medical tenet first do no harm, the prevailing medical advice is for the patient or consumer to discontinue use of the medicine at the early signs or symptoms of a serious ADR. Most patient and consumers self-treat with medicines outside the physician’s supervision or, in the case of nonprescription medicines, as part of their independent self-care. Hence, the question: is drug labeling for use by patients, consumers and practitioners adequately labeled with the symptoms associated with emergent serious ADRs? A case assessment study of the current labeling of commonly used prescription and nonprescription medicines was undertaken to answer this question.
FDA approved labeling was obtained from the NIH resource labeling library DailyMed for prescription medicines, and from currently marketed carton labeling of nonprescription medicines. Listings of early signs and symptoms of serious conditions associated with the selected medicines were obtained from the Mayo Clinic Foundation online library. Serious diseases/conditions examined included drug-induced cataract, acetaminophen-induced liver injury, ibuprofen-induced drug allergy, prednisone-induced cataract, and vancomycin-induced nephrotoxicity. Matching of warnings in the Adverse Reaction, Precaution, and Patient Counseling or Patient Information sections of approved labels with the Mayo listings of emergent symptoms was done to determine deficiencies in the drug labeling for serious ADRs.
None of the selected examples of FDA approved labeling provided a full listing of the early-signs/symptoms of ADRs associated respectively with the selected medicines.
This case assessment study focused on four widely used Rx and OTC medicines, finding deficiencies in the presentation of approved patient and consumer information about early signs and symptoms of selected serious drug-induced adverse reactions, including cataract, drug allergy, nephrotoxicity, and liver disease.
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