HEALTHBlack box, black holeAlthough efforts are made to alert physicians to new drug risks, those warnings are often swallowed up in an overabundance of information.By Susan J. Landers, amednews staff. April 18, 2005. More than three billion prescriptions are written per year, and each and every one of them comes with a complicated instruction manual known as a package insert. "Package inserts were intended to inform physicians about the risks and benefits of a drug," AMA Trustee Cecil B. Wilson, MD, recently told a Senate panel investigating drug safety. "Unfortunately, today's package insert has become a long and complicated legal document rather than a useful resource for physicians." Further obscuring matters is the fact that package inserts are intended to convey the gravest of alerts associated with about 500 drugs on the market -- the black-box warnings. How to keep up with new drugs is difficult enough, but add to that the need to stay abreast of postmarketing prescribing changes, and information overload is likely to swamp even the most careful prescriber. It is also becoming apparent that the health benefits promised by some pharmaceutical products could be overshadowing equally important safety concerns. Promoting the safe use of drugs already marketed now has the attention of Congress, the Food and Drug Administration, pharmaceutical companies, physicians and patients -- thanks to the recent high-profile withdrawal of the popular pain medication Vioxx (rofecoxib) and the addition of black-box warnings to its close Cox-2 inhibitor relatives, Bextra (valdecoxib) and Celebrex (celecoxib). The publicity generated by those changes would make it nearly impossible for physicians and patients to miss them. But often times, label changes receive far less public scrutiny. As a result, working to keep up with the advisories can lead to the prescriber's information overload. For example, last fall a label change was made to Strattera (atomoxeline hydrochloride), a drug for treating attention-deficit/hyperactivity disorder, and a black-box warning was added to the injectiable contraceptive Depo-Provera (medroxygrogesterone acetate). [...]Full text of American Medical News content is available to AMA members and paid subscribers.
Copyright 2005 American Medical Association. All rights reserved.
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