NCPA - National Center for Policy Analysis

Debate Over Drug Labels

May 3, 2000

Those tightly folded sheets of paper describing the risks and benefits of drugs have become a source of controversy. The medical jargon, which the Food and Drug Administration requires, confuses many patients -- with the result that the warnings go unread.

Even doctors are failing to read them, experts warn.

  • Duke University cardiologist Robert Califf estimates that less than 1 percent of physicians have seen a label in the last year.
  • One result is that in less than two years three widely-prescribed drugs have been pulled from the market -- in part because doctors ignored the package inserts.
  • Another is that people on medications sometimes die from drug interactions and other factors for which clear warnings were included in the literature.
  • The FDA contends it is aware of the problem and is trying to make package inserts more user-friendly, more informative and more consistent.

Experts say that doctors prescribe dozens of drugs and largely rely on their memories to avoid problems caused by drug interactions. But with doctors writing three billion prescriptions a year, that filtering method is bound to fail from time to time. Experts advise patients to beware and read the insert material carefully themselves.

Source: Rita Rubin, "Complex Drug Labels Bury Safety Messages," USA Today, May 3, 2000.


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