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October 2006 Issue

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UC Team Develops New, Faster Online Approach to Communicate FDA Drug Withdrawal Warnings

By Jill Hafner
Published October 2006

UC has developed a faster approach for informing consumers online when the Food and Drug Administration (FDA) withdraws a medication.

The new approach works with, a commercialfree, consumer health Web site produced by Ohio’s three medical research universities—UC, Case Western Reserve and Ohio State.

“Information about drug withdrawals may not reach patients quickly enough to prevent potentially dangerous side effects,” explains Peter Embi, MD, lead author on the UC-based study published in September’s online edition of the Journal of Medical Internet Research.

“Given the public’s growing use of the Web for health information, it’s important that Web-based consumer health content is kept up to date,” he adds, “particularly that involving withdrawal of a potentially harmful medicine.

“However,” says Embi, assistant professor of medicine and a researcher at UC’s Institute for the Study of Health, “it’s been shown that many sites don’t update their content for days, or even weeks, following an FDA drug withdrawal.

“Our new approach,” he says, “allows just one person to modify affected Web pages in less than an hour and within hours of an FDA drug withdrawal announcement.”

Embi says he hopes this new method will encourage other Web sites carrying critical consumer health information to adopt a similar 24-hour response standard to drug withdrawals.

“There’s evidence that patients continue to use medications for some time after their withdrawal, which occasionally causes harmful effects,” Embi explains, “so it’s important to inform the public as quickly as possible.”

Before developing the new approach, Embi and his team evaluated NetWellness’s previous update process following the FDA’s withdrawal of the painkilling, antiinflammatory drug Vioxx (rofecoxib) on Sept. 30, 2004.

Notified of the Vioxx withdrawal, NetWellness staff searched the site for the drug and related terms. References to Vioxx information were temporarily pulled and evaluated by medical experts. Content was either changed and reposted or permanently removed.

The researchers found that while this original process was ultimately effective, it took nearly three weeks and considerable human input to complete content changes after the Vioxx withdrawal.

To improve on this, the research team developed their new approach and then tested it following FDA withdrawal of the antiinflammatory drug Bextra (valdecoxib) on April 7, 2005.

The results were significantly better than with the previous approach, they say. In just 18 hours after the drug recall, all instances of Bextra on NetWellness were updated and active, says Embi.

The new method, initiated by the FDA’s automated MedWatch E-List alert and combined with modified technology and people processes, allows updates of all relevant NetWellness pages with minimal manual input and within 24
hours of a drug recall. Now when the FDA issues a drug withdrawal, the NetWellness team receives a MedWatch E-List alert, allowing them to immediately check the site’s database for instances of the drug name.

Instances are then hyperlinked using an automated find-andreplace function built into the site’s content management system.

Simultaneously, pages containing these references receive a hyperlinked warning box indicating important information about the withdrawn drug.

All hyperlinks point directly to a new NetWellness “warning” page containing information about the FDA alert and to additional links to either the FDA or the drug manufacturer’s Web site.

A recent study in the Journal of the American Medical Informatics Association reports that the majority of Web-based sources, including the popular consumer health site, took several days to update the Bextra drug information. A subscription-based health information Web site,, took 268 days to update Bextra content.

Embi plans to further automate this new update method by developing similar responses to other types of FDA health warnings relevant to consumers.

Study coauthors included Doris Haag, Charles Kishman, Stephen Marine and Mark McCuistion, all from UC, and Prasad Acharya, from Wright State University.

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