U.S.

Drugs Getting Better Labels

By CBSNews.com staff CBSNews.com staff

December 21, 2000 / 4:18 PM EST / CBS

U.S. health officials, moving to prevent dangerous prescribing errors, on Thursday proposed a new, easier-to-read format for the complex prescription drug labels written for doctors.

The updated labels should reduce the time doctors spend looking for information, making it more likely that patients will receive the safest and most effective treatment, the Food and Drug Administration (FDA) said.

The proposal "will make important information available in a clear, consistent and readable format that is essential to proper prescribing practices," FDA Commissioner Jane Henney said in a statement.

Drug labels for physicians, which actually are folded leaflets sometimes pages long placed inside product packages, contain detailed information, including warnings about side effects and possibly dangerous interactions with other medicines.

An FDA study found that physicians thought the labels were lengthy, complex and hard to use.

The FDA action comes after a string of drugs were pulled from the market at least in part because doctors apparently were not following the agency's advice on the labels.

For example, heartburn drug Propulsid came off pharmacy shelves this year after dozens of deaths in patients who were taking other medicines known to interact with the drug. The label explicitly warned about possibly dangerous drug combinations that could cause heart problems.

Under the FDA plan, new labels would feature a "Highlights" section with important information and provide the location for further details, the FDA statement said.

The proposed new labeling is expected to reduce practitioners' time spent looking for information, decrease the number of preventable medical errors, and improve treatment effectiveness.

Wrongly prescribing drugs is one of the types of medical errors blamed for as many as 98,000 deaths per year.

The FDA's proposal would apply only to "relatively new" prescription drug products, partly because doctors are least familiar with the most recently approved products, the agency statement said.