Antihistamine drug withdrawn by manufacturer

Astemizole, an antihistamine that has fallen out of favour with consumers in the wake of warnings about its safety and the emergence of less dangerous alternatives, is being withdrawn from worldwide markets by its manufacturer, Janssen Pharmaceutica of Titusville, New Jersey.

Greg Panico, a spokesman for Janssen Pharmaceutica, which is owned by Johnson and Johnson, said that the withdrawal was a voluntary business decision. “The decision to voluntarily discontinue it recognises that the allergy marketplace is crowded with a number of other drugs,” Mr Panico said. “it was a business decision.”

Existing supplies of astemizole are not being removed from pharmacies' shelves, but the drug will no longer be manufactured.

Last year the US Food and Drug Administration warned that astemizole—marketed under the brand name Hismanal—could cause fatal arrhythmias when given in high doses or in combination with certain other common drugs.

“We certainly indicated that we were very concerned about the product,” said John Jenkins, director of one of the administration's drug evaluation offices, “and that we would find it most beneficial to patients if they would withdraw the marketing.”

The withdrawal marks the second time in two years that an allergy drug has been taken off the market after safety concerns. Seldane—a once a day high dose formulation of the drug terfenadine—which was also found to cause fatal arrhythmias in combination with other drugs, was ordered to be removed from pharmacy shelves by the Food and Drug Administration at the end of 1997.

Hismanal: no longer on the market

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