To the Editor: Dr Lasser and
colleagues1 concluded that the safety of a new agent cannot
be known with certainty until it has been on the market for several
years. They defined a serious ADR according to changes in the
Physicians' Desk Reference. The most common causes of such
changes were hepatic toxicity, hematologic toxicity, and cardiovascular
toxicity. We believe that the problem of drug safety may be even greater than Lasser et al suggest.
Hampson JP, Harvey JN. Postmarketing Surveillance and Black Box Warnings. JAMA. 2002;288(8):955-959. doi:10.1001/jama.288.8.955