Study Claims FDA Is Inconsistent in Applying Black Box Warnings

The FDA has been inconsistent in applying black box warnings (BBWs) to drugs within the same class of products and patients may be unaware of potential safety concerns as a result, a new study says. The warnings, which highlight major risks and are the strongest drug-related safety notice the agency can add to a product’s label, have been applied by the FDA to more than 400 products. But in many cases, one product has received a BBW while other similar drugs have no mention anywhere in their labeling of the same safety concern, a study published this month in the Journal of General Internal Medicine found.
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