BETHESDA, Md. -- The FDA on Thursday unveiled its newMEDWatch system to encourage health care providers to reportto the agency adverse reactions to commercial drugs andbiologics and medical devices.

In a special communication in the Journal of the AmericanMedical Association dated Wednesday, FDA CommissionerDavid Kessler said: "If an adverse event occurs in perhaps onein 5,000 or even one in 1,000 users, it could be missed inclinical trials, but pose a serious safety problem when releasedto the market. Moreover, patients taking marketed drugs inconjunction with other drugs may experience interactions notrevealed during the premarketing phase."

Although reporting goes back to the 1950s and has beencentralized in the FDA since 1970, "in a typical year, fewer than1 percent of doctors report adverse events," Kessler said onThursday. One survey showed that barely one-half of allphysicians knew about the agency's old adverse reactionreporting system.

"Crude estimates suggest that only 5 to 10 percent of seriouseffects are reported," added James Todd, executive vicepresident of the American Medical Association (AMA).

Sidney Wolfe, a physician and director of the Public CitizenHealth Research Group, put it more graphically: "Lives andhealth are needlessly lost as a result of the pitifully lowadverse reaction reporting." In 1980, he said, the high bloodpressure drug Selecrin was pulled off of the market after eightmonths because of patients having severe kidney problems.Had one-fifth instead of one-tenth of the reactions beenreported, "the drug would have come off the market in fourmonths, and hundreds of thousands of people who wereinjured would have been spared," Wolfe said.

Besides simple bad reactions, "there are thousands of veryclinically threatening adverse reactions between drugs," saidWolfe, explaining that one drug can slow metabolism ofanother, resulting in an overdose of the second drug when anormal dose has been given.

At the heart of MEDWatch is the consolidation of six separatereporting forms into a single two-sided sheet, an incredible featfor a federal agency. Kathryn Zoon, director of the Center forBiologics Evaluation and Research (CBER), pointed out thatrequesting ot-release information on the form would provevaluable to the biotechnology industry.

A single mailing address at the FDA, as well as an electronicmailbox and a fax number, will also help simplify reporting.

The FDA is working with other institutions to aggressivelypublicize MEDWatch to doctors and other providers. Forexample, the AMA will alert all of the medical specialtysocieties and contact the deans of medical schools, said theAMA's Todd.

Kessler emphasized that doctors should report serious eventsrather than all adverse reactions, but that they should alsoreport suspicions that a medication may be involved in aserious event. "The Food and Drug Administration does notexpect you to wait until the evidence is compelling," he said.

By "serious" the FDA means a reaction that is fatal or life-threatening, that results in persistent or significant disability,that requires or prolongs inpatient hospitalization, or thatnecessitates medical or surgical intervention to precludeimpairment of a body function or permanent damage to a bodystructure.

Five to 8 percent of reports that the FDA receives concernbiologics, Jerome Donlon, director of FDA's Office ofEstablishment, Licensing and Product Surveillance at CEBR, toldparticipants at a workshop for biologics manufacturers.Regulations that will require reporting by biologicsmanufacturers are expected to be in place this fall, and "therules will be identical and compatible with those for drugs."Manufacturers are often unaware of adverse reactions. Yet theFDA could provide manufacturers with valuable information,such as the medical details of adverse events. The FDA isconducting a one-year pilot study to test its ability to quicklyput reports in manufacturers' hands.

The first phase will begin July 1. Interested manufacturersshould immediately contact MEDWatch, FDA, 5600 FishersLane, Rockville, MD 20852-9787.Manufacturers who want details on how to submit adversereaction reports to the FDA should contact John Nazario at(301) 295-9094.

-- David C. Holzman Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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