Doctors Prescribe Treatments Despite Blackbox Warnings
Many patients are prescribed drugs with "black box" warnings -- the strictest warning FDA can administer -- even if the drugs are not appropriate for their medical needs, according to a study published Tuesday in the Archives of Internal Medicine, the Wall Street Journal reports.
Researchers led by Cambridge Health Alliance and Harvard Medical School examined the health records of 324,548 outpatients from Boston-area medical clinics who were given at least one prescription from Jan. 1 to Dec. 31, 2002. They found that 33,778 patients were prescribed a medication that had a black box warning.
The warnings -- often found at the top of a drug's label and featured in the Physician's Desk Reference guide -- emphasize important drug guidelines, such as cautioning against a drug being prescribed with certain other drugs or advising against prescribing a drug to patients with particular medical conditions. Of the 33,778 prescriptions, researchers found that 2,354 were written in violation of a black box warning.
About 90% of the violations involved instances where a medication was prescribed for a person with a condition for which the drug was not recommended. About 1,000 patients were taking other medications that could have interacted with the drug listing the black box warning.
Researchers said that in some cases, physicians intentionally might have chosen to override a black box warning. They found that patients who were female and older than 75 and who took several medications were more likely to be given a drug in violation of a black box warning.
Although the overall number of patients who received a drug in violation of a black box warning is relatively small, researchers said that when compared with the total number of outpatient prescriptions dispensed in the study, "the absolute number of outpatients at risk is substantial." Researchers said that one solution to decrease medical errors would be for the FDA to "make these warnings more specific so they are more readily understandable by providers" (Corbett Dooren, Wall Street Journal, 2/14).
An abstract of the study is available online.
