FDA looks to move beyond black-box warning

WASHINGTON, Nov. 18 (UPI) -- A Food and Drug Administration official is calling for a new approach beyond black-box warnings to ensure physicians correctly prescribe drugs.

The move comes in light of a new study that found that many doctors do not follow the guidelines stated on labeling.

"Black-box warnings do not work well, at least not reliably so across the board, to communicate the risks," Anita Wagner, of Harvard Medical School's Department of Ambulatory Care and Prevention and one of the study's investigators, told United Press International.

The study found "that compliance with (black-box warnings) was highly variable," Wagner and colleagues wrote in the Nov. 18 issue of Pharmacoepidemiology and Drug Safety.

The finding "indicates the need for better methods of ensuring the safe use of medications that are considered to carry serious risks," Wagner's team added.

The report is the first attempt to quantify how often medications with black-box warnings are typically prescribed. The study surveyed nearly 930,000 ambulatory-care patients enrolled in 10 different health plans across the United States between 1999 and 2001 and found that approximately 42 percent received a prescription for a black-box warning drug.

When physicians did not follow the recommendations contained in the black-box warning, most of the time it involved a failure to obtain baseline laboratory monitoring.

Wagner said that improving the communication of drug risks would require collecting more information on the way medications are used in everyday practice and more data on what influences physicians' prescribing habits and helps them adhere to safety recommendations.

Making the content of black-box warnings more uniform could help, Wagner said. "There are so many of them, it makes it hard for prescribers to know what is important," she said. "The content varies widely and the way they are written varies widely."

Wagner said one thing that might aid industry is if the FDA clarified how it determines when to place a black-box warning on a drug. "We don't know which instances prompt FDA to put a black-box warning on drugs, so knowing more of the evidence would be of interest to industry," she said.

Another way to help communicate the black-box warning risks would be automated alerts given to patients at the point they obtain their drugs, Wagner said. She noted this would require a complete and current list of drugs that carry black-box warnings and recommended that the FDA establish such a database.

The agency may be moving in that direction. Dr. Paul Seligman, director of the FDA's Office of Pharmacoepidemiology and Statistical Science who wrote an accompanying commentary, told UPI the agency agrees with the recommendations made by Wagner and colleagues, including establishing a database of black-box warning drugs.

"We're actually moving towards ... having all labelings on an electronic database that's readily accessible to consumers and practitioners," Seligman said.

In the commentary, Seligman wrote, "It is time for a national strategy that drives the development of standardized methods for monitoring for side effects, and that leads us to best practices in education, risk communication and evaluation."

The strategy he envisions would involve the FDA, manufacturers and healthcare providers working together.

"The Centers for Education and Research on Therapeutics, one of which conducted this study, under the auspices of the Agency for Healthcare Research and Quality, offer an excellent venue convening academia and the leadership of organized medicine, medical educators, the pharmaceutical manufacturers and regulatory and public health agencies to chart a path forward," he wrote.

Jeff Trewhitt, spokesman for the Pharmaceutical and Research Manufacturers of America, told UPI his organization could not comment because they had not yet seen the study.