Hypoglycemia was not previously known to be a linezolid-associated adverse reaction. A case report describing symptomatic hypoglycemia in a linezolid recipient prompted a review of the US Food and Drug Administration Adverse Event Reporting System, which demonstrated a relationship between linezolid and hypoglycemia. A warning with this information was added to the linezolid package insert.

         Adverse drug reaction (ADR) is one of the most life threatening problems, and the economic burden of ADR is considerable. The main objective of this study was to assess the attitude of the Kerman health system staff, to evaluate their knowledge of the spontaneous reporting system and to identify the reasons for low reporting rate. In this descriptive study, a Persian translated questio...

OBJECTIVE To analyze the association between pioglitazone use and bladder cancer through a spontaneous adverse event reporting system for medications. RESEARCH DESIGN AND METHODS Case/noncase bladder cancer reports associated with antidiabetic drug use were retrieved from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) between 2004 and 2009 and analyzed by th...

Adverse drug reactions are causing a substantial amount of hospital admissions and deaths, which cannot be underestimated. Although a great effort has been put on the pre-marketing review during pharmaceutical product development, it cannot identify all possible adverse drug reactions. Currently, post-marketing surveillance is conducted through centralized volunteering reporting systems. Howeve...