The Food and Drug Administration has issued an alert warning physicians and pharmacists that it has received reports of inadvertent oral administration of the aerolized drugs Foradil and Spiriva.
The agency has received information on 30 cases of oral administration of the two drugs. Most of these reports did not indicate an adverse event, but one did involve difficulty breathing following oral ingestion. Another case involved hospitalization resulting from exacerbation of chronic obstructive pulmonary disease (COPD).
The Foradil Aerolizer (formoterol inhalation powder), a long-acting, selective β-2 adrenoreceptor agonist manufactured by Novartis Pharmaceuticals Corp., is indicated for the scheduled maintenance therapy for asthma and COPD and for the prevention of exercise-induced bronchospasm on an as-needed basis. The Spiriva HandiHaler (tiotropium inhalation powder), a long-acting anticholinergic agent manufactured by Boehringer Ingelheim Corp., is indicated for the scheduled maintenance therapy for asthma and COPD.
The misadministration occurs because these capsules resemble those typically taken orally. In addition, the capsules are supplied in packages that do not prominently display “NOT FOR ORAL USE.” Swallowing instead of inhaling the capsules may lead to delayed onset of action, reduced efficacy, and inadequate drug delivery, the FDA warned.
The FDA is working with the manufacturers to resolve the problems. In the meantime, the agency recommends:
▸ Counsel patients about the potential for confusion and how to avoid it.
▸ Avoid dispensing the capsules for inhalation without the inhalation device.
▸ If the capsules for inhalation are dispensed separately as unit-dose capsules, affix a cautionary label or statement indicating “FOR INHALATION USE WITH SPECIAL INHALER ONLY.”
▸ Advise patients to store the capsules for inhalation together with the inhaler.
▸ Highlight the “FOR INHALATION USE ONLY” statement on the product package and container if possible.