Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals
| Autor: | David U. Himmelstein, Leah Zallman, Steffie Woolhandler, Karen E. Lasser, Orlaith Heymann, Sidney M. Wolfe, David H. Bor, Cassie Frank |
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| Rok vydání: | 2014 |
| Předmět: |
Male
Drug medicine.medical_specialty Prescription Drugs Time Factors Drug-Related Side Effects and Adverse Reactions media_common.quotation_subject Legislation Off-label use Food and drug administration medicine Drug approval Adverse Drug Reaction Reporting Systems Humans Marketing Medical prescription Intensive care medicine Prescription Drug User Fee Act Drug Approval Drug Labeling media_common United States Food and Drug Administration business.industry Health Policy Legislation Drug United States Product Recalls and Withdrawals Female Patient Safety business Drug approval process |
| Zdroj: | Health Affairs. 33:1453-1459 |
| ISSN: | 1544-5208 0278-2715 |
| Popis: | After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients' exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently. |
| Databáze: | OpenAIRE |
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