Furberg, Moore and Psaty write that the new office should: Estimate the number and cause of serious injuries and death: No one at the FDA is routinely collecting such information, nor is anyone else in the government.

"It makes no more sense to monitor drug safety without knowing the extent of serious injuries than to have a National Highway Transportation Safety Administration that operated without information about automobile accidents or a Federal Aviation Administration (FAA) that does not know how many airplane crashes have occurred."

Identify new serious adverse reactions: The reports of adverse reactions are handicapped by limited physician participation, they say.

The FDA estimates that only 1 percent of adverse events are ever reported. For example, an average of 82 adverse reactions are reported each year for digoxin toxicity, which includes serious arrhythmias, but a systematic study of Medicare records found 202,211 hospitalizations in a seven-year period for digoxin-adverse reactions. Digoxin is prescribed for heart failure.

Some adverse reactions are disguised because an event might naturally be expected with the disease being treated. For example, it was hard to detect that flecainide -- a drug given for life-threatening ventricular tachycardia or fibrillation -- itself caused cardiac arrest.

Monitor the effectiveness of previous safety alerts: The FDA has no organized program to be sure that important warning messages are being communicated to doctors and the general public -- and whether they are being heeded. Even boxed warning labels have little effect.

"Safety monitoring should include surveillance of the most important known and expected risks and regular public reporting on the response of the public and prescribing physicians."

Operate an early warning system: The system would focus on the medical pr
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Contact: Robert Conn
Rconn@wfubmc.edu
336-716-4587
Wake Forest University Baptist Medical Center
20-May-1998