Important Information on the Correct Use of Spiriva and Foradil Capsules - Full Version
On February 29, 2008 the Food and Drug Administration issued a public health advisory titled: Important Information on the Correct Use of Spiriva and Foradil Capsules.
I am Pat Clarke from F-D-A's Center for Drug Evaluation and Research.
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 capsules are to be used in the HandiHaler device and Foradil capsules in the Aerolizer device. These devices deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung disease and bronchitis. 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 National Poison Control Center 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.
We urge healthcare providers and patients to report serious side effects that may be associated with the use of Spiriva or Foradil capsules to us at the FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot GOV slash M-E-D-W-A-T-C-H.
Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash C-D-E-R.
Date created: March 3, 2008