Important Information on the Correct Use of Spiriva and Foradil Capsules
Important Information on the Correct Use of Spiriva and Foradil Capsules
Important Information on the Correct Use of Spiriva and Foradil Capsules
2008-03-03
On 29, February 2008 , the Food And Drug Administration (FDA) the American's equivalent to the Saudi Food and Drug Authority (SFDA) 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.
Both products Spiriva (tiotropium bromide inhalation powder) Capsules and
Foradil (formoterol fumarate inhalation powder) 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 and bronchitis.
Both products will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled.
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 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 .
REPORT ADVERSE DRUG REACTIONS TO THE SAUDI FDA
The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at:
