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U.S. Department of Health and Human Services

Drugs

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Public Health Advisory: Important Information on the Correct Use of Spiriva and Foradil Capsules

2/29/2008

FDA is issuing this public health advisory to highlight the correct use of Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) capsules. Spiriva and Foradil capsules are to be used in the HandiHaler (Spiriva) and Aerolizer (Foradil) devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung disease (COPD), including chronic bronchitis and emphysema. The medication in the Spiriva or Foradil capsules is specifically designed to be inhaled through inhalation devices. Both Spiriva and Foradil will not treat a patient’s breathing condition if the contents of a capsule are swallowed rather than inhaled.

FDA is highlighting for patients the following information on the correct use of Spiriva and Foradil capsules:

  • Do not swallow the Spiriva or Foradil capsules.
  • The contents of Spiriva and Foradil capsules are only to be inhaled using their respective inhalation devices.  Remove the capsule from the blister package and place the intact capsule into the inhalation device prior to inhalation.
  • Follow the instructions contained in the patient information leaflet provided with your prescription explaining how to use the Spiriva Handihaler or Foradil Aerolizer

Doctors, nurses, and pharmacists should discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer.  If a patient who is prescribed Spiriva or Foradil does not experience breathing improvement, the health care provider should ask the patient if he or she is swallowing the medicine rather than inhaling it.

FDA and the American Association of Poison Control Center’s (AAPCC) National Poison Data System have received many reports of patients swallowing Foradil and Spiriva capsules rather than placing the capsules in the inhalation devices.  Reports of ingestions indicate that few patients experienced side effects from the swallowed capsules.

The Spiriva HandiHaler and Foradil Aerolizer patient information includes highlighted statements stating that the capsule contents are to be inhaled and not swallowed.  FDA will continue to monitor the incorrect use of Spiriva Handihaler and Foradil Aerolizer and, as needed, will continue to work with the manufacturers to improve the medication labeling and promote patient education for the correct use of these medications.