a special program of the National Emergency Medicine Association (NEMA)
Week: 562.5 Guest: Dr. Bob Temple, Assoc. Dir. For Medical Policy. FDA Center for Drug Evaluation and Research Topic: Ban on Seldane Producer/Host: Steve Girard
NEMA: A ban on Seldane....coming up...
SPOT: 15 years in the prevention of heart disease, stroke and trauma- the National Emergency Medicine Association. Call 800-332-6362.
NEMA: Seldane, a non-drowsy anti-histamine, was one of the most popular drugs of its kind.... but the U.S. Food and Drug Administration has announced a ban on Seldane. Dr. Bob Temple of the agency's center for drug evaluation and research, says problems occurred when Seldane reacted with some anti-biotics and anti-fungal medications....
TEMPLE: The toxicity is that it interferes with the electrical properties of the heart, and makes people susceptible to a kind of rhythm that can be life threatening. It's a kind of what's called ventricular tachycardia, which is a rhythm that sometimes makes you dizzy, sometimes makes you faint, and sometimes is lethal.
NEMA: The maker of Seldane is protesting the ban, but it's not likely to win. That same company is now producing Allegra, a new, non-drowsy anti-histamine, which is the same as Seldane, without the reactive substance. Dr. Temple says it's just a case of playing it safe...
TEMPLE: It's just that, in this case, we felt that the potential risk... after all, it's a matter of life or death... and that we didn't think there should be any risk of this kind, when it was so completely unnecessary.
NEMA: Dr. Bob Temple of the FDA. I'm Steve Girard, for The Heart of the Matter.