Downed Pharmaceutical’s Black Box Located
September 6, 2000
RANSON, NJ—Scientists announced late Wednesday evening that the black box warning of the ill-fated medication Seldane (terfenadine) had been located near the top of its package insert, and that its contents, still fully intact, reveal the terrifying final seconds of its brief market run.
"What appears to have happened is that some users of the medication were developing serious or even fatal arrhythmias as a consequence of its use," said recovery effort supervisor G. Allen Jackson, Pharm D.
Transcript of Black Box Contents
|...[Terfenadine] undergoes extensive metabolism in the liver by a specific cytochrome P-450 isoenzyme. This metabolic pathway may be impaired in patients with significant hepatic dysfunction (alcoholic cirrhosis, hepatitis) or who are taking drugs such as ketoconazole or erythromycin (a macrolide antibiotic), or other potent inhibitors of this isoenzyme. Interference with this metabolism can lead to elevated terfenadine plasma levels associated with QT prolongation and increased risk of ventricular tachyarrhythmias (such as torsades de pointes, ventricular tachycardia, and ventricular fibrillation) at the recommended dose...|
"This led to a sudden crippling of Seldane's credibility as a marketable pharmaceutical, as well as a critical loss of support from several of its funding engines."
All told, at least 17 deaths were attributed to Seldane before rescue workers were able to fully remove the devastated product from warehouses across the nation in Januray 1997.
The nonsedating antihistamine, once popular among travelers to high-allergen areas, disappeared from pharmacies almost overnight, remaining as a cautionary tale of what researchers like Jackson term "flying off the shelves."
The unsuccessful attempt at that time to safely land the drug at Hoechst Marion Roussel (now Aventis) headquaters in Ranson, NJ, was followed by the equally tragic demise of Hismanal (astemizole), a similar nonsedating antihistamine, whose black box warning still awaits discovery by concerned scientists in this country and abroad.
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