The Food and Drug Administration has officially returned asthma inhalers containing metaproterenol sulfate to prescription status seven months after an agency official decided virtually unilaterally to switch them to over-the-counter status.
The official's decision sparked a controversy because it was made without consulting the agency's Pulmonary-Allergy Drugs Advisory Committee. Last month, the committee recommended, 4 to 3, that the agency return the inhalers to prescription status. Subsequently, Boehringer Ingelheim, which markets the drug as Alupent, announced it would take it off the over-the-counter market.
Some physicians had expressed concern that the drug could be misused if sold over the counter, particularly by children and teen-agers, and could lead to heart conditions or even death.
In announcing its decision in Friday's Federal Register, the FDA said it had decided that "reservations exist within the medical community" about whether the drug "can be safely marketed without the prescription limitation and professional supervision of the drug's use in asthma patients." It also said the drug's approval "has led to unintended confusion and controversy that, if allowed to continue, may disrupt the relationship between physicians and their patients and produce unnecessary anxiety among asthma sufferers" seeking relief through an over-the-counter drug.