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Date: | Wed, 23 Nov 2005 08:29:36 -0800 |
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http://www.medscape.com/viewarticle/517424
Inconsistent Adherence to Black Box Warnings: A Newsmaker Interview
With Anita Wagner, PharmD, DPH
Laurie Barclay, MD
Nov. 18, 2005 — Editor's Note: Physicians often fail to comply with
Food and Drug Administration (FDA) black box warnings for drugs,
especially with regard to laboratory monitoring, according to the
results of a large survey reported online in the Nov. 18 issue of
Pharmacoepidemiology and Drug Safety.
The Investigators in this retrospective study analyzed automated
claims data from 929,958 enrollees in 10 geographically separated U.S.
health plans. Specifically, they looked at use of 216 black box
warning drugs and drug groups. From Jan. 1, 1999, through June 30,
2001, 42% of enrollees received at least one drug carrying a black box
warning. In nearly half of all cases where the black box warning
included recommendations for baseline laboratory monitoring, these
recommendations were not followed. There were few instances of
prescribing during pregnancy of drugs absolutely contraindicated in
pregnancy, and almost no coprescribing of contraindicated drugs with
the two QT-interval-prolonging black box warning drugs evaluated.
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