In ending a controversy over a recent Food and Drug Administration decision, the maker of an asthma inhaler containing metaproterenol announced yesterday that it would stop over-the-counter sales of its product.
Boehringer Ingelheim Ltd., makers of Alupent metered-dose mist inhalers, notified the FDA on Monday that it would take the step, after an agency advisory panel recommended Friday that the FDA return the drug to prescription-only status and asked the company to halt television ads for the product. The Ridgefield, Conn., firm stopped its TV campaign later Friday night.
The FDA switched the inhalers to over-the-counter status last Oct. 26, without consulting its Pulmonary-Allergy Drugs Advisory Committee and without being prompted by a manufacturer. Boehringer began selling the inhalers over the counter in January. Dorsey Laboratories, which markets the drug as Metaprel, did not promote over-the-counter sales.
The FDA said that Alupent's safety and effectiveness when used as directed is not in question, based on more than a decade of prescription sales. Many physicians, however, said they feared that over-the-counter sales, particularly to children and teen-agers, would lead to overuse and possible injury or death.
Boehringer said it is asking pharmacies to dispense the aerosols only by prescription. Other retailers, particularly supermarkets, which alone account for up to 30 percent of all over-the-counter sales, are being asked to remove the inhalers from their shelves and await instructions.
The company said it took the action not because of any concern over the safety or effectiveness of the aerosols, but to give the medical community time "for a further review" of the issue.