Coverage of FDA medication boxed warnings in commonly used drug information resources.

Practical Considerations for Prescribing Benzodiazepines and Opioids.

INTRODUCTION The Food and Drug Administration is responsible for evaluating and approving the medications we prescribe. The FDA reviews post-market experience and monitors adverse drug reactions or unexpected effects. One of the strictest warnings the FDA can apply to a medication is a Boxed warning or Black Box warning. “Drugs that have special problems, particularly ones that may lead to deat...

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...

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...

Black Box Warnings in Prescription Drug Labeling:

Prescription drugs are unavoidably associated with adverse effects, but the benefits of using such drugs outweigh the accompanying risks so long as the expert judgment of a licensed practitioner is first applied in the decision to use a drug for a particular patient. Most risks for prescription drugs appear in descending order of importance in the drug’s labeling, i.e., the package insert. The ...

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