Pharmacists interviewed by SN differ over whether the Food and Drug Administration will actually recall Seldane, a widely prescribed antihistamine, because of rare, but potentially deadly side effects.
The FDA announced Jan. 13 that it was proposing to recall Seldane, which it said can cause fatal heart-rhythm abnormalities, particularly when it is taken with erythromycin and ketoconazole.
Seldane, a product of Hoechst Marion Roussel, Kansas City, Mo., was marketed in 1985 as the first prescription antihistamine to relieve the effects of seasonal allergies -- including sneezing, tearing, runny nose and itching -- without causing the drowsiness of older antihistamines.
"It's interesting that they'd take action against Seldane because another antihistamine, when administered with some erythromycin, can cause the same problems as Seldane," said Vern Shaffer, pharmacy manager at Bi-Lo Foods & Pharmacy's Sandy Plaza location in DuBois, Pa.
"The product has been out there for a significant length of time with fairly minimal side effects. People haven't been dropping like flies. I think it will stay out there," said Bill Marth, director of pharmacy at Schenectady, N.Y.-based Price Chopper Supermarkets.
"The product has been considered relatively effective for 10 years. As long as the caution is taken not to utilize it with those two preparations, why would you recall it? It's no more unsafe then it was six months ago," Marth said.
But another pharmacist disagreed, pointing out that newer, safer allergy medications had supplanted Seldane.
"Allegra is out now and it does essentially the same thing as Seldane without the possible side effects. Also, Seldane just went generic. It's not as important a drug to the manufacturer anymore. I don't think they'll put up a strong fight," said Cyrus Miller, director of pharmacy at Schwegmann Giant Super Markets, New Orleans.
The FDA approved Allegra last July. It is also manufactured by Hoechst Marion Roussel. Another allergy medication, Nasalcrom, marketed by McNeil Consumer Products, Fort Washington, Pa., was approved for over-the-counter use this month.
"There is not the same need for Seldane. That's the tack the FDA is going to take," Miller said. He added sales of Seldane have dropped recently.
The FDA rarely bans drugs, although manufacturers often withdraw drugs on their own. The agency has issued several warnings before about the dangers of Seldane, but has not acted to take the drug off the market.
Some pharmacists SN surveyed were surprised to hear that the FDA was threatening to recall Seldane in light of the fact that the agency had just approved a generic version of Seldane to be marketed by the Ivax Corp. of Miami. "There's a lot of money at stake," Shaffer said. "That's another issue altogether."
The FDA said it was proposing to withdraw approval of Seldane, Seldane D and generic versions of the drugs because several newer antihistamines now available are considered safer.
The New York Times reported that "Seldane can cause dizziness and fainting when the heart-rhythm irregularity is short-lived. But if the irregularity persists, it can lead to potentially fatal rhythms known as ventricular tachycardia and ventricular fibrillation."
According to Dr. Robert J. Temple, an FDA official, the agency knew of 40 documented cases of serious heart-rhythm abnormalities that Seldane had apparently caused and that led to eight deaths.
Seldane manufacturers have 30 days to request a hearing to contest the action, and Hoechst Marion Roussel, which sells $440 million of the drug worldwide, said it would fight the action.
According to data compiled by IMS America, a market research firm in Totowa, N.J., from January through November 1996, Seldane's total sales in the US were more than $189 million. More than seven million prescriptions were filled for Seldane during that period.
Price Chopper's Marth said Seldane is not dangerous if consumers heed the proper warnings.
"When customers fill their prescriptions, pharmacists should tell them there are other medications [erythromycin and ketoconazole] that shouldn't be taken simultaneously with Seldane. If used properly according to the manufacturer's guidelines, it shouldn't present a problem. Seldane is an excellent product -- I take it myself."
