Author Affiliations: Center for Drug Evaluation and Research Policy, Food and Drug Administration, Rockville, Md.
In this issue of THE JOURNAL, Lasser and colleagues1
examine the timing and nature of the black box warnings added to labeling,
as reflected in the Physicians' Desk Reference, and
of removal of drugs from the market to address the question of whether clinicians
should hesitate to prescribe new drugs that may have unrecognized adverse
drug reactions (ADRs). Premarketing trials in a few thousand (usually relatively
uncomplicated) patients do not detect all of a drug's adverse effects, especially
relatively rare ones. Frequent postmarketing labeling changes are therefore
inevitable and should be anticipated. Sometimes the new information is so
important it fundamentally changes the place of the drug in therapy (eg, leads
to second-line status) and sometimes the postmarketing discoveries cause the
drug to be withdrawn.
Temple RJ, Himmel MH. Safety of Newly Approved DrugsImplications for Prescribing. JAMA. 2002;287(17):2273–2275. doi:10.1001/jama.287.17.2273