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U.S. Department of Health and Human Services

Drugs

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MedWatch: Managing Risks at the FDA

When the Food and Drug Administration approves a medical product, 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 adverse reactions, product problems, and use errors 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."

MedWatch especially encourages the reporting of serious adverse reactions. 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, device use errors, 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."

Examples of MedWatch alerts for 2003 include:

  • Viga Tablets: The FDA announced a voluntary recall of Viga tablets by Best Life International of Clarkston, Wash. The tablets were sold as a dietary supplement with claims to increase sexual performance. The FDA warned consumers against using the product, which was found to contain the prescription drug sildenafil, even though the ingredient is not listed on the drug's label. Sildenafil is the active ingredient contained in Viagra, a drug available by prescription for treatment of erectile dysfunction. People who are taking nitrates for heart disease should not take sildenafil
  • An unsuspecting user of Viga tablets could develop life-threatening lowering of blood pressure.
  • Gynecare Intergel Adhesion Prevention Solution: Gynecare Worldwide, a division of Ethicon Inc. of Somerville, N.J., voluntarily withdrew this product and urged customers to immediately stop using the device. The product is intended to be used in gynecological surgery to reduce post-surgical adhesions. There were postmarket reports of several serious problems, including postoperative pain and the need for repeat surgeries.
  • Risperdal (risperidone): Janssen Pharmaceutica Products L.P. of Titusville, N.J., announced important changes to Risperdal, a treatment for schizophrenia. The labeling was updated to include a warning of cerebrovascular problems, including stroke, in elderly people with dementia. The update is based on data from four clinical trials. The company also reminded health professionals that, like other antipsychotic drugs, Risperdal is not indicated to treat dementia.

"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 25,000 voluntary reports each year, which are evaluated along with reports received from manufacturers.

The agency has a number of ways to alert the public about important safety information. The MedWatch Web site is an example of one way the agency broadcasts safety information. MedWatch sends e-mail notification of all safety alerts for drugs, biologics, dietary supplements, and devices, as well as monthly safety labeling changes for drugs, to a growing e-mail list of both health care professionals and consumers. By 2004, the number of subscribers to the MedWatch e-mail list jumped to 45,000, 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. It is easy to sign up. Just visit the MedWatch home page at www.fda.gov/medwatch and click on "Join the E-list." Names and e-mail addresses of MedWatch subscribers are not shared with other organizations.

MedWatch also works with 170 "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 database that allows a safety evaluator to compare it to similar reports. As few as a handful of reports 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. "Their reports may prompt timely actions that protect and improve public health."


How to Report to MedWatch

Log onto the MedWatch site to learn the different ways to submit a report: