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Over 200 Medicines Include Black Box Warnings in Their Prescribing Instructions

FDA Prescribing Warnings Often Ignored, Harvard Study Finds

BOSTON, MA -- December 2, 2005 -- Some doctors disregard urgent alerts known as black box warnings when prescribing medicines, a recent Harvard report found (Pharmacoepidemiol Drug Saf 2005 Nov 18). A black box warning is the Food and Drug Administration's strongest drug labeling message. This prominent alert is included in the prescribing instructions contained within the package insert, and must also appear in any advertisements for the drug. It is for high risk prescription drugs that may cause serious injuries or death.

The study analyzed the health records of about 930,000 patients in ten health care plans over a 30-month period. About 40% of these patients took medications that had black box warnings. The researchers classified the black box warnings as applying to all patients, to children, to women only, or to women of childbearing age. Some warnings required prescription drug users to take laboratory tests, and others mentioned harmful drug interactions.

The doctors' compliance with black box warnings varied, ranging from 0.3% to 49.6%, depending upon the drug. They were most lax about drug monitoring. Almost half the patients were not given laboratory tests that were recommended in black box warnings before drug treatment could begin. Too often, patients were not tested on an ongoing basis, especially for liver enzyme or potassium levels. However, the doctors did a better job in helping patients avoid harmful drug interactions with other medications.

Widespread Use of Black Box Warnings

Over 200 medicines include black box warnings and it is difficult for doctors to know what is important, according to Anita Wagner, an assistant professor at Harvard Medical School and the lead author of the study. In a recent interview, she suggested several ways to improve the effectiveness of black box warnings (Medscape Medical News, November 18, 2005, Inconsistent Adherence to Black Box Warnings: A Newsmaker Interview With Anita Wagner). These are:

  • Have black box warnings clearly state the magnitude of risk and the evidence that underlies any monitoring recommendation.
  • Make black box warning content easy to understand for both clinicians and patients.
  • Create systems such as alerts in electronic medical records when a high-risk drug is prescribed.

The authors of the Harvard study concluded that current black box warnings are not effective. They stressed the need for improving black box warnings and for finding better methods of ensuring the safe use of high-risk medicines.

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