Database size and power to detect safety signals in pharmacovigilance.

Most regulatory agencies and pharmaceutical companies focus the majority of their pharmacovigilance on safety signal identification in large databases. GlaxoSmithKline (GSK) has > 100 drugs marketed worldwide. In order to determine which database has the highest statistical power to detect safety signals in three large global databases, ten GSK marketed drugs were randomly selected for review in the three databases.

Effect of consumer reporting on signal detection: using disproportionality analysis.

Pharmacovigilance objectives and activities are designed to protect the health of consumers and are generally based on data acquisition from spontaneous adverse event reports (SADRs). SADRs come from different sources, including healthcare professionals, consumers, lawyers, other pharmaceutical companies, regulatory agencies and so on. Pharmacovigilance activities derived from SADRs include signal detection and description of the safety profile of the drug.

Hyponatremia and syndrome of inappropriate anti-diuretic hormone reported with the use of Vincristine: an over-representation of Asians?

Purpose: This retrospective study used a pharmaceutical company's global safety database to determine the reporting rate of hyponatremia and/or syndrome of inappropriate secretion of anti-diuretic hormone (SIADH) among vincristine-treated patients and to explore the possibility of at-risk population subgroups.

Method: We searched the Eli Lilly and Company's computerized adverse event database for all reported cases of hyponatremia and/or SIADH as of 1 November 1999 that had been reported during the use of vincristine.

Results: A total of 76 cases of hyponatremia and/or SIADH associated with vincristine use were identified.