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Downed Pharmaceutical's
Black Box Located
Contents reveal medication's terrifying final moments
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.
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Transcript of Black Box Contents
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...[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...
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"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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