black box warning


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A cautionary label for all therapeutic agents and/or products—and relevant literature—that the FDA regards as being hazardous to health if incorrectly administered

black box warning

A written advisory supplied by a pharmaceutical company to health care professionals whenever a medication causes any serious side effect(s). Under U.S. federal regulations, this advisory is mandatory and must be highlighted by “a prominently displayed box.”
References in periodicals archive ?
Antipsychotics already carry black box warnings about increased mortality in this population.
Panel members then voted 15-8 in favor of adding a black box warning to convey this information to prescribers.
In addition to withdrawing the drugs or adding a black box warning, the FDA may consider making COX-2-selective NSAIDs second-line drugs, adding contraindications in selected patient populations, and requiring a patient medication guide to be dispensed with all prescriptions.
There were 68,121 prescriptions for patients 17 years old and younger in the United Healthcare database in the year before the October 2004 black box warning, compared to 61,561 afterward.
Black box warnings on hormone therapy products prescribed for postmenopausal women should be updated to include data from a recent trial suggesting that combination therapy does not prevent mild cognitive impairment, the Food and Drug Administration has advised.
Pediatric Antidepressant Drugs and Black Box Warnings 115
The new black box warning also contains language on screening and monitoring for TB, including for patients who tested negative for latent infection, the companies noted.
Emergency physicians should not let the black box warning on droperidol discourage their use of the drug in agitated patients, Dr.
The prominent black box warning at the front of the package insert contains a new requirement that patients of childbearing potential must have two negative urine or serum pregnancy tests with sensitivity of at least 25 mIU/mL before the drug is prescribed, even though Soriatane (acitretin), unlike the antiacne drug Accutane (isotretinoin), isn't typically used in women with childbearing potential, Dr.
As a result, EpiCeram should not present the same concerns associated with both of these treatments, including the recent Black Box warning the FDA now requires on immunosuppressants.
Despite the many studies showing that Reglan was associated with tardive dyskinesia, the drug's manufacturers did not warn of it on the label until 2004, and did not add the Black Box warning until February 2009.