In the United States, a boxed warning (also sometimes called a "black box warning") is a type of alert that appears on the package insert for certain prescription drugs. The U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.
Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns. It is not necessarily true that a physician and patient will have a conversation about a drug's boxed warning after it is issued. For instance, an FDA-mandated boxed warning decreased rosiglitazone use by 70%, but that still meant 3.8 million people were given the drug. Later research indicated that after receiving an FDA advisory, there was a decrease in rosiglitazone use, due to a combined effect of media exposure, advisory, and scientific publications, whereas pioglitazone (with a similar advisory) did not similarly decrease in use. This challenges the idea that physicians and patients will have a conversation after a boxed warning is issued. Throughout the country, boxed warnings will be translated into prescription patterns differently by different physicians.
In 2005, the FDA issued a boxed warning regarding the risk of atypical antipsychotics being prescribed among elderly patients with dementia. This advisory was associated with a decrease in use of antipsychotics, especially in elderly patients with dementia.
Read more about Boxed Warning: Examples
Famous quotes containing the words boxed and/or warning:
“Is it the lumberman, then, who is the friend and lover of the pine, stands nearest to it, and understands its nature best? Is it the tanner who has barked it, or he who has boxed it for turpentine, whom posterity will fable to have been changed into a pine at last? No! no! it is the poet.... All the pines shudder and heave a sigh when that man steps on the forest floor.”
—Henry David Thoreau (1817–1862)
“We have not the motive to prepare ourselves for a “life-work” of teaching, of social work—we know that we would lay it down with hallelujah in the height of our success, to make a home for the right man. And all the time in the background of our consciousness rings the warning that perhaps the right man will never come. A great love is given to very few. Perhaps this make-shift time filler of a job is our life work after all.”
—Ruth Benedict (1887–1948)