Evidence Supporting US Food and Drug Administration Drug Safety Communications
Menée à partir des données 1992-2000 de la cohorte européenne EPIC portant sur 451 743 personnes (âge moyen : 50,8 ans ; 71,1% de femmes ; durée moyenne de suivi : 16,4 ans), cette étude analyse l'association entre une consommation de boissons gazeuses sucrées ou édulcorées et la mortalité toutes causes confondues (41 693 décès) ou par cancer
The US Food and Drug Administration (FDA) is responsible for ensuring that approved drugs are safe and effective. However, the clinical trials that form the basis for FDA approval typically enroll fewer than 1000 patients and have follow-up durations of 6 months or fewer. Thus, most serious safety risks may only become evident after FDA approval. In fact, for approximately one-third of new drug approvals, the FDA issues a new safety communication or warning after initial approval.In this issue of JAMA Internal Medicine, Tau and colleagues characterize which data sources were used to identify the initial safety signals that were the basis of drug safety communications issued by the FDA between 2010 and 2018, and offer insight into the strength and reliability of the evidence underlying communications and warnings. They found that 38% of these communications were based on safety data ascertained from the FDA’s Adverse Event Reporting System (FAERS), 36% on clinical trial data, and 26% on other sources, including epidemiological studies using observational data. The FAERS data, the basis for the majority of communications, are publicly available and may offer early insights to inform drug safety surveillance that ideally should be confirmed using clinical trial or observational data sources. However, these data are limited because adverse event reporting to FAERS is voluntary for patients and clinicians, which leads to substantial nonreporting, and those events that are reported often lack key details and may not be definitively because of use of the drug.