Summaries of safety labeling changes approved by FDA-boxed warnings highlights March-June 2016.

Summaries of safety labeling changes approved by FDA-Boxed warnings highlights, January-March 2017.

As part of FDA’s MedWatch program, important changes to the safety labeling of drugs and therapeutic biologics, including boxed warnings, are posted on the agency’s website. Boxed warnings are ordinarily used to highlight (1) an adverse reaction so serious in proportion to the potential benefit from the drug that it is essential that the reaction be considered in assessing the risks and benefit...

Summaries of safety labeling changes approved by FDA-Boxed Warnings Highlights October-December 2014.

Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study

Objective To determine if drugs approved through the Food and Drug Administration's expedited development and review pathways have different rates of safety related label changes after approval compared with drugs approved through standard non-expedited pathways.Design Retrospective cohort study.Setting FDA public records, January 1997 to April 2016.Participants 382 FDA approved drugs.Main outc...

Update on the safety and efficacy of commercial ultrasound contrast agents in cardiac applications

Ultrasound contrast agents (UCAs) are currently used throughout the world in both clinical and research settings. The concept of contrast-enhanced ultrasound imaging originated in the late 1960s, and the first commercially available agents were initially developed in the 1980s. Today's microbubbles are designed for greater utility and are used for both approved and off-label indications. In Oct...

Medication safety: opening up the black box.

To cite: Mintzes B. BMJ Qual Saf 2013;22:702–704. Medication-related adverse events are a major cause of disability and death, and one of the most common reasons that patients attend hospital emergency departments. Much of this harm is preventable, either because a less hazardous treatment is available, the medicine is not really needed, or it is inappropriate for this specific patient. Many in...