From: Reuters
Published December 12, 2007 12:52 PM

Wide Solvay heart drug use poses danger: FDA staff

BELTSVILLE, Maryland (Reuters) - An experimental Solvay SA drug for a potentially fatal heart ailment could lead to deaths if used broadly in the population, a U.S. medical reviewer will argue on Wednesday.

The assessment comes as a U.S. Food and Drug Administration advisory panel mulls whether to recommend approval of the intravenous drug for atrial fibrillation (AF).

The committee will vote later this afternoon on whether to advise approval of the drug, known generically as tedisamil.

In AF, the heart's upper chambers do not pump effectively, putting patients at risk for blood clots and strokes. About 2.2 million Americans suffer from the condition.

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"With widespread use if approved: There will be deaths from ventricular arrhythmias (abnormal heartbeat rhythm); there will be deaths from bradycardia (slow heart beat) and hypotension (low blood pressure)," Thomas Marciniak, FDA's medical team leader for the cardiovascular and renal unit, said in a document prepared for the advisory panel meeting.

"What will happen to safety in real-world use, particularly considering the complex dosing?" he wrote.

FDA staff reviews a company's application ahead of agency advisory meetings. An expert panel then makes a recommendation. Typically, the FDA follows those recommendations.

A Solvay official presented a plan to control risks of the drug if it is approved, by monitoring patients and employing a data safety board to continually assess benefits and risks.

The plan "should effectively mitigate the concerns related to the use" of the drug by "pro-actively addressing the known risks," said Earl Sands, the Belgian company's chief medical officer for U.S. research.

(Reporting by Kim Dixon; editing by John Wallace)

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