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Keywords:

  • drug approvals;
  • clinical toxicology;
  • overdose labeling;
  • labeling revision;
  • pharmacoepidemiology

ABSTRACT

Purpose

Adverse drug reactions, including overdose are a major cause of morbidity and mortality, yet clinical toxicology data is limited at the time of drug approval. This study was conducted to determine the quality of clinical toxicology data available for newly approved pharmaceuticals and time to labeling revisions.

Methods

The labeling data of 100 new molecular entities (NMEs) approved between 2005 and 2011 was systematically reviewed. Initial approval data and subsequent labeling revisions were evaluated. The type and quality of clinical toxicology data present at the time of approval as well as the time to any labeling revisions was recorded. The presence of black box warnings and Risk Evaluation and Mitigation Strategies (REMS) was noted.

Results

Of the NMEs reviewed, 27 had agent-specific toxicology data at approval. General recommendations for overdose management were made in 45 cases. Eight pharmaceuticals had toxicology updates during the study period. The average time to labeling revision was 27.4 months. Expanded adverse effects from case reports comprised 7/8 of the updates, and animal data was added in one case. Over a third of the NMEs had a black box warning or REMS status, suggesting potential for significant human toxicity.

Conclusions

Our study suggests there is a paucity of clinical toxicology data at the time of drug approval, with a notable lag time between initial approval and labeling revisions. This lack of toxicology data limits the ability of providers to optimally care for poisoned patients. Copyright © 2013 John Wiley & Sons, Ltd.