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Pulzium: A matter of risk

Regulation

Pulzium: A matter of risk

FDA's Cardiovascular and Renal drugs advisory committee unanimously voted to recommend against approval of Pulzium tedisamil from Solvay S.A. to convert patients from atrial fibrillation to sinus rhythm based in part on what is known about the product, and even more on what isn't known.

The committee was worried by arrhythmias that occurred in patients who received Pulzium, and felt that results from Solvay's trials can't be generalized to the patients who would be exposed to the compound in the U.S.

In addition, the committee expressed concerns that the complex dosing and administration

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