USA – FDA Warns of Dosing Errors With Compounded Injectables

The US Food and Drug Administration (FDA) last week warned that differences in how drugmakers and compounders label the strength of injectable drugs may lead to dangerous dosing errors.

« Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently, » FDA writes.

For small volume parenteral drugs and biologics, FDA recommends that strength per total volume be the primary and most prominent expression of strength, followed by strength per milliliter enclosed by parentheses.

According to FDA, two recent MedWatch reports cited medication errors that led to patients overdosing on compounded injectables that featured strength per milliliter more prominently on the labels than the strength per total volume.

In one case, a patient was accidentally administered 50 times the prescribed dose of fentanyl. In that case the IV bag containing the compounded drug was labeled 50 mcg/mL in large font with the strength per total volume (2,500 mcg/50 mL) underneath it in smaller print, which the MedWatch report cited as the cause of the error…