Seldane (terfenadine), manufactured by Marion Merrell Dow, had been approved the year before, and Hismanal (astemizole) was already under F.D.A. review.
For example, Seldane, an antihistamine, and the gastrointestinal drug Propulsid both triggered a potentially fatal heart arrhythmia more often in women than in men.
A tabloid took an inventory of the drugs she carried round with her, listing Aldactazide, Decadron, Demerol, Imipramine, methocarbamol, Prilosec, Propulsid, Seldane, Synthroid, temazepam, Vicodin and Xanax.
Sepracor developed derivatives of two allergy drugs, Seldane and Claritin, which are now sold as Allegra by Aventis and as Clarinex by Schering-Plough.
As doctors investigated this unusual case, they uncovered previous reports of dangerous irregularities in heartbeat among Seldane patients.
For example, she said, it was mainly women who suffered life-threatening abnormalities in heart rhythm when they took the antihistamine Seldane in combination with erythromycin, a common antibiotic, or ketoconazole, an antifungal agent.
Schering-Plough doggedly pursued the approval of Claritin, spurred, no doubt, by the phenomenal success of Seldane.
She was taking the antihistamine Seldane (not for allergies but for a sinus condition) and then began using an antifungal drug, ketoconazole, to prevent a vaginal yeast infection.
Later they found that risk in Seldane patients to be associated with ketoconazole or erythromycin, a widely used antibiotic.
In August 1990, at the F.D.A.'s urging, Seldane's manufacturer, Marion Merrell Dow, sent letters to doctors warning of these potentially fatal drug interactions, and in 1992 the F.D.A. ordered warning statements, outlined by a prominent black box, to appear at the top of the label and packaging on Seldane and Hismanal.
Both Seldane and Hismanal were already on the market, and neither caused cancer in animals.
