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May 1, 2002

Safety of Newly Approved Drugs: Implications for Prescribing

Author Affiliations

Author Affiliations: Center for Drug Evaluation and Research Policy, Food and Drug Administration, Rockville, Md.

JAMA. 2002;287(17):2273-2275. doi:10.1001/jama.287.17.2273

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the drug in therapy (eg, leads to second-line status) and sometimes the postmarketing discoveries cause the drug to be withdrawn.