"Black-box" Warnings Are Forgotten Or Ignored By Some Doctors

The So-called Black Box Is FDA's Highest Form Of Drug Safety Alert

In the February 14, 2006 edition of the medical journal Archives of Internal Medicine there is a report that many patients are told by their doctors to use prescription drugs with "black-box" warnings in situations contrary to the drug-safety information and guidance set forth in those warnings.

Black-box warnings are the highest form of drug safety alert and, because of their importance, usually appear at the top of a drug's package insert, or label.  Typically the black-box warning brings attention to serious side effects associated with the drug, and provides guidance about how to minimize the risks of those side effects -- such as to not prescribe a particular drug with another drug, or to patients with certain pre-existing medical conditions.

In this study report published by the Archives of Internal Medicine, researchers examined the health records of 324,548 outpatients seen at several Boston-area medical clinics from January 1, 2002 to December 31, 2002.  The researchers found that 33,778 patients were prescribed a medication that had a black-box warning; of those, 2,354 prescriptions were contrary to the guidance set forth in the subject black-box warning.

In about 1,000 cases, the patients were simultaneously taking one or more drugs that the black-box warning said should be avoided so as to prevent a possible drug-drug interaction.  It is presumed that in most of those situations the black-box warning was forgotten by the prescribing doctor.

Interestingly, most of the instances which involved a black-box drug, about 90%, also involved prescribing the black-box drug to treat a disease or medical condition for which use of that drug was not even approved by the FDA. This type of prescribing is commonly referred to as "off-label" use.  In some of those cases, just as the doctor decided to use his or her own discretion as opposed to relying on the FDA-approved use, it is presumed that the prescribing doctor may have purposely chosen to ignore a black-box warning.

While this study found that the number of patients who received a black-box drug in a situation contrary to the substance of the black-box warning is relatively small, i.e., compared with the total number of outpatient prescriptions examined for the study, according to the researchers "the absolute number of outpatients at risk is substantial."

As always, we urge patients to know about the serious side effects, and the symptoms thereof, which are associated with any prescription drug they are taking.  To that end, we provide this listing of side effects and drug interactions for reference.

(Posted by: Tom Lamb)