Wyeth-Ayerst's Cordarone IV Approved In USA

Wyeth-Ayerst Laboratories, a division of American Home Products, has received marketing approval in the USA for its injectable antiarrhythmic Cordarone IV (amiodarone), for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically stable ventricular tachycardia (VT) in patients refractory to other therapies.

Cordarone IV can also be used to treat patients with VF/VT for whom oral Cordarone (which has been available in the USA since 1985) is indicated, but who are unable to take oral medication. The injectable product will have seven-year exclusivity by virtue of it being granted orphan drug status, the company points out. The IV form now becomes available in more than 100 countries; its full US approval came through only after two instances of "approvable" recommendations by Food and Drug Administration advisory committees.

Hypotension Most Common Side Effect - Seen In 16% The most common side effect in these trials was hypotension (noted in 16% of patients) but this required discontinuation of therapy in only 1.6%. Label warnings indicate this side effect. Cordarone IV is contraindicated in patients with cardiogenic shock, marked by sinus bradycardia and/or second- and third-degree AV block in the absence of a functioning pacemaker.