FDA launches drug safety information Web site

This resource, which was required by a 2007 law, is now only a click away.

By Susan J. Landers — Posted Nov. 17, 2008

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The Food and Drug Administration has a new Web page intended to provide one-stop shopping for postmarket drug safety information. Many physicians say the agency has, to a large extent, succeeded in its mission.

The site provides links to an array of data, including information on drug labels; medications that have risk evaluation and mitigation strategies; postmarket studies; information from MedWatch; and quarterly reports on drugs being evaluated for safety issues.

The development of the Web site (link) is one of the many requirements of the Food and Drug Administration Amendments Act of 2007. The measure was enacted last fall to help correct numerous drug safety problems that have plagued the agency over the past few years.

"By placing Web links to these up-to-date resources on a single page, we're helping consumers and health care professionals find drug safety information faster and easier," said Paul Seligman, MD, MPH, associate director of safety policy and communication in the agency's Center for Drug Evaluation and Research. "This type of communication is aimed at helping consumers and health care professionals make well-informed decisions about medication use."

The AMA has advocated for improved risk communication between the FDA and physicians for several years, and provided numerous comments leading up to passage of the drug safety law.

A round of applause

Curt Furberg, MD, PhD, professor of public health sciences at Wake Forest University Baptist Medical Center in Winston-Salem, N.C., praised the site. "It's a wonderful compilation of very relevant information," he said. Dr. Furberg, a close observer of the drug safety scene, served for several years on the FDA's Drug Safety and Risk Management Advisory Committee.

"You can get drug-specific information, including warning letters, which I try to monitor, but it's a pain to remember to go in there and see what's new," he said. "This [site] has everything in it."

However, after exploring the site further, he did find a flaw.

"The only communications are those of the FDA," he said. "I wish they had a section on other safety communication.

For example, the FDA had not posted a recent study by Dr. Furberg and others that concluded that inhaled anticholinergics were associated with a significantly increased risk of cardiovascular death or stroke among patients with chronic obstructive pulmonary disease.

Dr. Furberg sent the FDA a copy of the paper, which was published in the Sept. 24 Journal of the American Medical Association.

Overall, though, the site appears to be "a reasonable starting point, which will hopefully get better with time, experience and feedback from physicians and the general public," said David Fassler, MD, clinical professor of psychiatry at the University of Vermont in Burlington.

After reviewing the information on antidepressants, Dr. Fassler found "the site isn't terribly user-friendly. A simple search returns more information than most people want or need."

Keith Roach, MD, associate professor of clinical medicine and public health and epidemiology at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City, was an enthusiastic reviewer. "I like it," he said. "It's nicely organized. It has all the package inserts in one spot, which is great, so you don't need to have your PDR handy.

"It's definitely going to be a bookmark on my screen." Dr. Roach also favored the site's link to the National Institute of Health's MedlinePlus, which he called "my preferred place to get unbiased patient care information."

If he had to fault the drug safety site, it would be for providing "almost too much information."

All seem to agree that the unknown element is, now that the site has been built, will physicians and others come?

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