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MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 13, 2007.
This announcement describes a fatal overdose of a protease inhibitor in an infant and discusses how to prevent such occurrences.
New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; September 15, 2010.
This announcement describes revised dosing recommendations designed to prevent overdosing immunocompromised pediatric patients.
Tavernise S. New York Times. January 15, 2015.
This newspaper article discusses an investigation into how a saline solution that had been manufactured specifically for training purposes was inadvertently distributed and used for actual care and led to patient harm and death.
Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Silver Spring, MD: US Food and Drug Administration; September 29, 2018.
US Food and Drug Administration. March 8, 2019.
Errors of commission during complex procedures can contribute to patient harm. Drawing from an analysis of medical device reports submitted to the Food and Drug Administration, this announcement seeks to raise awareness of common adverse events associated with surgical staplers and implantable staples. User-related problems include opening of the staple line, misapplied staples, and staple gun difficulties. Recommendations include ensuring availability of various staple sizes and avoiding use of staples on large blood vessels.