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U.S. Food and Drug Administration

MedWatch: FDA's 'Heads Up'
on Medical Product Safety

by John Henkel

When the Food and Drug Administration approves drugs and other medical products, the agency takes every precaution to make sure these products are safe when they are marketed.

But that's not always the end of the story. The true picture of product safety actually evolves over the months and even years that make up a product's lifetime in the marketplace. Because the clinical trials that help gauge product safety are conducted on small groups of patients--usually ranging from a few hundred to several thousand--problems can remain hidden, only to be revealed after hundreds of thousands or even millions of people use the product.

For example, clinical trials can't assess the effects of every new drug in combination with other approved drugs. So it is possible that a patient could have a serious reaction from a new drug when taken with another drug in a combination that was not tested in trials.

That's why, through the MedWatch program, FDA conducts "postmarketing surveillance" of medical products to identify safety concerns and take necessary action. MedWatch depends on doctors, dentists, nurses, pharmacists, and other health professionals to pass on to FDA details of serious adverse reactions and medical product problems.

MedWatch reports played major roles in recent decisions to remove the painkilling drug Duract (bromfenac sodium) from the market following reports of deaths and injuries. FDA also moved to withdraw the blood pressure treatment Posicor (mibefradil dihydrochloride) after learning of serious adverse reactions.

"To withdraw a drug or device from the marketplace is a very significant step, and it's something that is done only when necessary," says Michael Friedman, M.D., FDA lead deputy commissioner. "But when such an action occurs, it proves that the postmarketing surveillance system is working just as it should." He adds that most of the agency's postmarketing actions are less severe than withdrawal from the market. Educational efforts such as labeling changes or letters to health professionals warning of new concerns are more typical responses.

The agency has had a postmarketing surveillance program in place since 1961. It replaced an earlier system sponsored by the American Medical Association. FDA's system eventually evolved into five separate reporting forms for different products, such as drugs or medical devices. In 1993, then-FDA Commissioner David A. Kessler, M.D., citing confusion with the multiple forms, moved to consolidate them, and MedWatch was born. Since then, MedWatch has logged more than 85,000 voluntary reports, mostly from health professionals. (The agency also has a separate mandatory reporting system required by law for medical product manufacturers and certain health-care facilities.)

The MedWatch program has four goals:

While participation in MedWatch is voluntary, FDA encourages anyone aware of a serious adverse reaction, including consumers, to make a MedWatch report.

"Health professionals are helpful to us because they usually have the clinical or medical documentation we need to assess the situation," says Dianne Kennedy, FDA's MedWatch director. "Often, consumers don't have detailed information. However, consumers certainly can make reports, but whenever possible, they should work with a health professional in filling out a report." She adds that in cases where consumers are embarrassed or have other reasons why they do not want to report a problem through a health professional, FDA still wants the information and encourages consumers to make the report alone.

Products covered under MedWatch include drugs, biologics (such as blood products), and medical devices (such as heart valves or kidney dialysis machines). FDA also wants reports of serious reactions due to dietary supplements, infant formulas, and medical foods (such as low-nitrogen products used by patients with severely reduced kidney function). Adverse reactions to artificial sweeteners, preservatives, and other food additives also should be reported.

'Serious Adverse Reaction'

The key point to remember when making a MedWatch report is that the adverse reaction should be serious. FDA does not want reports of all adverse reactions, especially ones that are listed in a product's labeling, such as a minor rash following drug therapy. "All drugs have side effects," says Kennedy. "If we were to get reports of all adverse reactions, we'd be overwhelmed, making it difficult for us to focus on the issues with the most public health impact." She says patients can avoid making an unnecessary report by asking their doctors or pharmacists what side effects to expect from products.

Report to MedWatch only if one or more of the following occurs:

FDA emphasizes that it is not necessary to prove that a medical product caused an adverse reaction--a suspected association is sufficient reason to make a report.

FDA also wants to know about defective or malfunctioning medical products. Any concerns about quality, performance or safety of any drug or device warrant a MedWatch report. Some product problems may occur during manufacturing, shipping or storage. For example, a pharmacist may notice an off-color tablet in a drug container. A consumer may hear a rattling noise in a bottle, possibly indicating broken glass. Or a nurse may notice a wiring defect on a medical device.

The identity of patients and other persons making MedWatch reports is kept confidential. The agency has regulations in place to preserve privacy.

What does FDA do with the information from MedWatch reports? "All reports are entered into a postmarketing surveillance database and are evaluated by a postmarketing safety evaluator," says Kennedy. Once an adverse event or product problem is identified, the agency can initiate various actions, including:

MedWatch reports also may prompt the agency to require manufacturers to conduct postmarketing studies on a product or to make manufacturing facilities available for inspection.

Getting the Word Out

The MedWatch program relies on a collaborative network of about 140 health professional and trade organizations to spread the word about MedWatch to their constituents and to encourage participation. The list of these MedWatch "partners" reads like a Who's Who of the health profession, with collaborators such as the American Medical Association, the College of American Pathologists, and the National Association of Chain Drug Stores. Partners help by inserting the MedWatch form into their journals or newsletters and sharing important new safety information from FDA with their members.

"We're now going directly to the major pharmacy chains, and several have already joined us as partners," says Gale White, MedWatch deputy director. She says it makes sense to have pharmacies as partners so the agency can have another direct route to patients and any adverse reactions that may occur.

Meanwhile, Kennedy says the MedWatch program has proven its value repeatedly by helping patients escape illness or even death. "The bottom line," she says, "is that we have this system in place and it works."

John Henkel is a staff writer for FDA Consumer.

How to Make a MedWatch Report

FDA offers several ways for health professionals or consumers to submit MedWatch reports:

Reports of serious adverse reactions or problem products also may be made to product manufacturers, where, by law, they must be reported to FDA.

If you have any questions about the reporting process, call 1-800-332-1088; press "0" or wait on the line. Or send questions by e-mail to

Other Kinds of Reporting

Though FDA accepts MedWatch reports for a variety of medical products, there are two product categories that have different ways of reporting. They are:

FDA Consumer Magazine (November-December 1998)

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