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J Allergy Clin Immunol. 2006 Jan;117(1):40-4.

The "black box" warning and allergy drugs.

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Finch University School of Health Sciences, Chicago Medical School, Chicago, IL 60657, USA.


In the past years, several drugs commonly used by allergy specialists have received a "black box" warning added to their package insert at the direction of the Food and Drug Administration (FDA). A "black box" warning is the highest level of 5 possible warning categories found in the package insert. The FDA has never articulated the basis for "black box" warnings. They generally appear to be based on clinical data, but occasionally can be based on serious animal toxicity. In the last several years, several drugs commonly used by allergists have received recommendations for "black box" warnings. Long-acting beta-agonists (salmeterol and formoterol) received "black box" warnings because of reports of the occurrences of severe asthma exacerbations in some patients with asthma, with some associated death. Topical calcineurin inhibitors (tacrolimus and pimecrolimus) received a recommendation for application of a "black box" warnings because of a possible increase of cancer developing in patients taking these drugs. Although the addition of a "black box" warning was recommended by the FDA Pediatric Advisory Committee for these 2 topical agents, the FDA has not yet implemented this warning. Informed consent principles require that a patient be adequately informed of the risks (among other components) of any recommended treatment. The risks, as described, of the long-acting beta-agonists and topical immunosuppressants should be presented to the patients to aid them in deciding whether they are willing to take these drugs when recommended by their physician.

[Indexed for MEDLINE]

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