FDA Logo links to FDA home page
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

horizonal rule

Email this Page
To a Friend
email a friend


MedWatch: Managing Risks at the FDA

By Michelle Meadows

When the Food and Drug Administration approves a medical product, it means the agency has determined that the benefits of the product outweigh the risks. "But every product the FDA approves carries some risk," says Norman Marks, M.D., director of the FDA's MedWatch program. "And sometimes there are risks that only come to light after a product gets on the market and is used in larger numbers of patients who differ from those studied before approval. They may differ in the complexity of their health problems or other medications that they use, for example."

That's where MedWatch comes in.

MedWatch, the FDA's safety information and adverse event reporting program, plays a critical role in the agency's postmarketing surveillance--the process of following the safety profile of medical products after they've begun to be used by consumers. Through MedWatch, a voluntary program, health professionals report serious adverse reactions and problems related to drugs, biologics, medical devices, dietary supplements, cosmetics, and infant formulas.

"Consumers can also send in reports, but we encourage them to work with a health professional to submit because we'll get a much richer report," Marks says. "Health professionals have clinical information that will help us better evaluate the report."

Marks adds, "What we mean by 'serious' adverse reactions is death and disability, life-threatening problems, hospitalization, congenital anomalies, and other problems that aren't listed on the label as known side effects." MedWatch also accepts reports of product quality problems with drugs or devices, suspected product tampering or counterfeit drugs, medication errors due to packaging problems or name confusion, and any other unexpected problems with the product that could pose a safety risk.

Once the FDA receives early signals of possible safety issues, the agency can rapidly identify problems and take appropriate actions, including broadcasting new safety information as "MedWatch alerts."

MedWatch alerts in 2003 include:

"The FDA's MedWatch program has two main goals," Marks says. "We want to facilitate the reporting of problems in to the agency and we want to get safety information out to the public." MedWatch receives about 22,000 reports each year. The agency has a number of ways to alert the public about important information. The MedWatch Web site pulls as much safety information together as possible to make it easier for the public to find. MedWatch sends e-mail notification of all safety alerts and monthly safety labeling changes for drugs to a growing e-mail list of both health care professionals and consumers. By 2003, the number of subscribers to the MedWatch e-mail list jumped to 32,000, from the 5,000 people who signed up in 2000. People on the list receive safety alert summaries by e-mail, with a hyperlink that directs them to more detailed information. Names and e-mail addresses of MedWatch subscribers are not shared with other organizations.

MedWatch also works with 161 "MedWatch partner" organizations to widely disseminate new safety information. For example, the American Pharmacists Association receives e-mail notification of MedWatch safety alerts and includes this information in its own weekly e-mail bulletin, sent to over 64,000 pharmacists nationwide. FDA alerts also appear on a Web site called Pharmacist.com, a joint project of the American Pharmacists Association and the National Association of Boards of Pharmacy.

The MedWatch program is also exploring opportunities to work with large health care systems that are already collecting adverse event and medication error reports. "This will facilitate the receipt of these reports by the FDA," Marks says. "We also work with partners like the American Association of Nurse Anesthetists to encourage their members to report to the FDA. It can be hard to get busy health professionals to report, but what we hope is that they see the whole process working--reports coming in from them and the resulting new safety information going back to them in order to make their work easier and their patients safer."

After the FDA evaluates reports, the result may be safety alerts, letters to health care professionals, labeling changes, product withdrawals, or further postmarketing research. When the FDA receives a MedWatch report, it is entered into a powerful database that allows a safety evaluator to compare it to similar reports. As few as a handful of signals, sent in from locations as diverse as Idaho, Arizona, Florida, and Vermont, may trigger a careful investigation by the FDA and a manufacturer.

"We want the public to know that we depend on their reports," Marks says. "They could prompt important actions that improve the public health."

How to Report to MedWatch

Log onto the MedWatch site to download the reporting form. You can:


horizonal rule