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ADVERSE EVENTS AND PRODUCT DEFECTS REPORTING

 WASHINGTON, June 3 /PRNewswire/ -- The Food and Drug Administration today announced a program to improve the safety of drugs, biologics, medical devices, dietary supplements, medical foods, infant formulas and other regulated products by encouraging health professionals to report serious adverse events and product defects.
 The new program -- called MEDWatch -- is a comprehensive approach to FDA's post-marketing surveillance and is aimed at more involvement by health professionals and a better focus of their reporting.
 Clinical trials that precede product approval typically include safety data on several hundred or several thousand patients. Once on the market, the much wider use of the drug or medical device occasionally brings out additional data on the safety and efficacy of the product that can have a bearing on its use. The purpose of MEDWatch is to bring this information to FDA's attention as soon as it is gathered by health professionals.
 "MEDWatch is not just a new FDA system; it is a way of making reporting of adverse events and product problems a part of the culture of health care providers," said FDA Commissioner David A. Kessler, M.D. "Physicians, nurses and others who care for patients are the first to know when a drug or medical device does not perform as it should. The sooner they report it to FDA, the faster the agency can analyze the problem and take corrective action."
 The American Medical Association, Pharmaceutical Manufacturers Association, Public Citizen Health Research Group and more than 50 other organizations representing health professionals have agreed to promote the program to their members by special mailings, ads and other means.
 As part of MEDWatch, the agency has developed several ways to make it easier for health professionals to report adverse events involving almost all regulated products. Concerns with vaccines will continue to be reported separately through the Vaccine Adverse Events Reporting System.
 An important part of MEDWatch is a simplified reporting form that replaces five other forms previously issued for the same products.
 The self-addressed, one-page form, which can be folded and mailed postage-free, will be made widely available in several publications, including the Physicians' Desk Reference, the FDA Medical Bulletin and AMA Drug Evaluations.
 In addition, the agency has established for adverse event information a special 24-hour, seven-day-a-week toll-free telephone line. Health professionals will also be able to make their reports electronically by computer.
 FDA keeps track of the performance of drugs, biologics and medical devices on the basis of mandatory reports -- from manufacturers and device distributors and user facilities -- and voluntary reporting by health care professionals.
 FDA has repeatedly identified side effects that did not emerge during the clinical trials of drugs. Adverse drug reaction reports led to the recall of such drugs as suprofen, which in 1986 was found to cause flank pain syndrome, and temafloxacin, which last year was linked to hemolytic anemia in some patients.
 Two years ago, FDA discovered a potentially fatal latex sensitivity that prompted an alert to health professionals. In 1992, voluntary reports by health professionals about product quality problems resulted in 52 drug recalls. In addition, manufacturers voluntarily accepted many FDA recommendations for corrective actions to improve the quality of their products.
 However, in a typical year fewer than one-third of all adverse drug reaction reports and fewer than one-half of medical device problems reported to FDA involve serious patient outcomes. Moreover, a survey has indicated that as many as 50 percent of physicians are not aware of FDA's adverse events reporting system.
 MEDWatch is designed to stimulate voluntary reporting by all health care professionals, and to focus them on adverse events that represent a serious health hazard.
 To encourage maximum participation in the program, the agency will hold next year a special conference on medication- and device-induced problems for academics and practitioners. FDA will also make a sustained effort to keep health professionals informed about the use of their MEDWatch reports, and it will encourage medical, pharmacy, dental and nursing schools to include in their curricula lectures on adverse event and product problem recognition and reporting.
 Adverse events that should be reported include the patient's death, life-threatening illness or injury, hospitalization, disability, congenital anomaly and experiences that required intervention to prevent permanent impairment of health. MEDWatch also needs to be informed about suspected contamination, questionable stability, defective components and poor packaging or labeling of regulated products.
 FDA is one of the eight Public Health Service agencies in HHS.
 -0- 6/3/93
 /NOTE: Attention TV broadcasters: please use open caption for the hearing impaired./
 /CONTACT: Mike Kubic of the Food and Drug Administration, 301-443-3285 or, after hours, 301-365-7626/


CO: Food and Drug Administration ST: District of Columbia IN: MTC SU:

DC-KD -- DC007 -- 4874 06/03/93 10:19 EDT
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Date:Jun 3, 1993
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