The Food and Drug Administration was rebuffed yesterday when one of its advisory panels voted, 4 to 3, to recommend that the agency return Alupent, a popular inhaler for asthma victims, to prescription-only status.
The FDA's Pulmonary-Allergy Drugs Advisory Committee also unanimously called for an end to television advertising of the inhalers because it said the ads can do "the greatest harm" to some asthmatics by encouraging improper use.
Alupent is the Boehringer-Ingelheim Ltd. trade name for metaproterenol, which for a decade had been available only by prescription until the FDA made it an over-the-counter drug last October.
Dr. James P. Mann, the FDA official most responsible for the switch, did not consult the panel beforehand. He told members yesterday that he hadn't expected any controversy over his decision, and, if he had, he would have run it by them.
But the switch set off a storm, particularly among organizations of pediatricians, allergists and lung specialists. They feared that the change would lead to overuse and misuse of the drug--particularly by children, teen-agers and adults not under supervision of a doctor--that in turn could cause irregular heartbeat and heart stoppage.
The prescription drug's label had advised against allowing children under 12 to use Alupent because of a lack of evidence of safety and efficacy.
The panel will take up the issue again in June. FDA officials did not comment on what action they would take.