FDA Moves to Simplify Drug Warning Labels

Sheryl Gay Stolberg / New York Times 22dec00

The Food and Drug Administration announced plans yesterday to simplify the warning labels that doctors rely on in prescribing medications.

Agency officials and drug safety experts say the move could help reduce deadly medication mix-ups and other prescribing errors.

The labels, called package inserts, are written by pharmaceutical companies,

and approved by federal regulators, to give doctors the fine print about prescription drugs: their approved uses, dosages and possible side effects, including potentially dangerous interactions with other medications. But the inserts are cumbersome, and doctors often ignore them.

"Physicians told us that they weren't using the current label because its format is just too dense," said Dr. Jane E. Henney, the commissioner of the FDA. She said the proposed changes, which will highlight safety warnings, would "clearly be helpful in terms of reducing medical errors."

With more and more new prescription drugs being approved each year, and more prescriptions being written, experts say patients face a growing risk that they will be killed or injured by the medications that are supposed to help them. Doctors have a hard time keeping up with all the new medicines on the market, and with FDA warning letters about their risks.

"The pharmaceutical industry invests millions, hundreds of millions of dollars in new products, but neither their labeling nor the FDA's warning letters have been able to optimize the way these new medicines are used," said Dr. Raymond Woosley, chairman of the pharmacology department at Georgetown University. "The package insert is not a very user-friendly source of information for physicians."

So the FDA is proposing new rules that would create an easy-to-read format for doctors to follow, in much the same way the agency simplified food labels for consumers in the early 1990s.

The plan, which will not become final until President-elect Bush takes office, calls for the package inserts to highlight safety warnings and new additions to drug labels. Recently approved medicines will also be flagged, so that doctors can pay special attention to the way they work in combination with the other drugs their patients take.

Woosley and other drug safety experts say the proposed rules, if adopted, would be helpful for doctors. But they said labeling changes alone could not solve the complicated problem of medication errors. In a report issued last year, the Institute of Medicine, an arm of the National Academy of Sciences, said medical errors killed as many as 98,000 Americans each year. The report said that as many as 7,000 deaths were attributable to medication errors, which include the prescribing or dispensing of the wrong drugs. By contrast, about 6,000 people die each year in workplace injuries.

But the problem is more than a matter of labeling. Pharmacists sometimes misread doctors' handwriting. Many drugs have names that sound alike, causing confusion for doctors and nurses. And in a fragmented health care system, doctors often do not know what other drugs their patients are taking.

"Even with the perfect label," Woosley said, "drugs may still not be used perfectly."

The FDA's 231-page proposal, which is to be published in today's Federal Register, is now open to public comment for 90 days