Drug safety- FDA concern about black box warning

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Dear Members,

According to the Code of Federal Regulations, a boxed warning is defined and utilized as:

Special problems, particularly those that may lead to death or serious injury, may be required by the Food and Drug Administration to be placed in a prominently displayed box. The boxed warning ordinarily shall be based on clinical data, but serious animal toxicity may also be the basis of a boxed warning in the absence of clinical data. If a boxed warning is required, its location will be specified by the Food and Drug Administration. The frequency of these serious adverse reactions and, if known, the approximate mortality and morbidity rates for patients sustaining the reaction, which are important to safe and effective use of the drug, shall be expressed as provided under the “Adverse Reactions†section of the labeling.

(Code of Federal Regulations. Title 21: Food and Drugs. Volume 4, Part 201.57(e). http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/cfr_2002/aprqtr/pdf/21cfr201.57.pdf.)

Tarun Wadhwa