US Food and Drug Administration Safety Advisories and Reporting to the Adverse Event Reporting System (FAERS)
| Autor: | Richard L. Morrow, Colin R. Dormuth, Barbara Mintzes, Thomas J. Moore |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Canada
medicine.medical_specialty 030226 pharmacology & pharmacy Food and drug administration 03 medical and health sciences Patient safety Adverse Event Reporting System 0302 clinical medicine Adverse Drug Reaction Reporting Systems Medicine Pharmacology (medical) Adverse effect Pharmacology United States Food and Drug Administration business.industry Australia Odds ratio United Kingdom United States 3. Good health Clinical trial Health Communication Spontaneous reporting Emergency medicine Observational study Patient Safety business |
| Zdroj: | Pharmaceutical Medicine. 34:135-140 |
| ISSN: | 1179-1993 1178-2595 |
| Popis: | The US Food and Drug Administration (FDA) and other major regulators regularly issue safety advisories about licensed drugs with new adverse effects that have been documented through observational studies, clinical trials, and spontaneously reported adverse drug events. To assess the possible effects of a representative group of FDA Drug Safety Communications on the reporting of the specific adverse effect featured in the advisory on new cases reported to the FDA Adverse Event Reporting System (FAERS). We examined 16 FDA Drug Safety Communications issued from 2010 to 2015 that had not previously been the focus of advisories from regulators in the UK, Canada, or Australia. We compared the reports of the adverse effect in the 8 calendar quarters preceding the advisory and in the 4 quarters following. We measured change in reporting frequency by calculating the event reporting odds ratio (ROR) for the post-warning compared to the pre-warning periods. We defined a credible association of the advisory with increased reporting as a ROR ≥ 2.0 and p value of |
| Databáze: | OpenAIRE |
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