Are Drug Warning Labels Effective Enough?

March 27, 2000

At Least Two Drugs Companies Would Probably Say "No"

ROCKVILLE, MD-Two prescription drugs were either restricted or removed from the market last week prompting questions of whether the warning labels issued with the drugs are being overlooked. The withdrawal of Rezulin and the restrictive usage of Propulsid have prompted the Food and Drug Administration (FDA) to renew its efforts to make sure the labeling process is effective. Currently when a drug is packaged, it includes an information sheet explaining the drug's usage, warnings, and possible side effects. For example, Propulsid was marketed for severe nighttime heartburn in adults and its label was strengthened five times since it was approved to warn physicians about prescribing it to patients at risk of heart problems. Yet the FDA found several fatal cases of children who were prescribed Propulsid and cases of adults with potential heart conditions who had been prescribed the drug.

In each case, once problems started to occur, the FDA and the marketing company relabeled the drug. The label was reworded and physicians were notified either through FDA press releases or letters sent directly by the marketing company. Whether this is an effective means of communication, though, seems to be questionable. Doctors are overwhelmed by paperwork and a new drug information sheet may go unnoticed. The FDA believes the problem stems from the majority of physicians referencing the Physicians' Desk Reference, a monthly publication, instead of the actual drug labels.