FDA Cautions Against Swallowing Tiotropium and Formoterol Capsules

Yael Waknine


February 29, 2008

February 29, 2008 — Many patients receiving treatment for asthma and chronic obstructive pulmonary disease (COPD) are swallowing capsules of inhalation powder rather than placing them in inhalation devices, the US Food and Drug Administration (FDA) announced today in a public health advisory.

Although reports to the FDA and the National Poison Control Center indicate that few patients experienced adverse events from capsule ingestion, this method of administration will not treat a patient's respiratory condition, according to an alert sent today by MedWatch, the FDA's safety information and adverse event reporting program.

The contents of tiotropium bromide inhalation powder (Spiriva, Boehringer Ingelheim) and formoterol fumarate inhalation powder (Foradil, Novartis) capsules should be inhaled using the HandiHaler and Aerolizer devices, respectively, thereby ensuring delivery of the medication to the lungs.

Patients should be instructed regarding the correct use of these devices and advised to consult the informational leaflet provided with the prescription if needed.

Those who do not appear to improve with treatment should be asked whether they are swallowing the capsule rather than inhaling it.

Tiotropium bromide inhalation powder is indicated for the long-term, once-daily maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema.

Formoterol fumarate inhalation powder is indicated for the long-term, twice-daily treatment of bronchoconstriction associated with COPD. It also may be used for the maintenance treatment of asthma and the prevention of bronchospasm in patients aged 5 years and older with reversible obstructive airway disease, including nocturnal asthma.

Adverse events related to use of tiotropium and formoterol inhalation powder capsules should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.


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