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Spiriva, Foradil Often Misused, FDA Says

Mar 4, 2008 | Parker Waichman LLP

Spiriva and Foradil capsules, drugs used in inhalation devices to treat breathing problems, have been accidentally swallowed by some patients.  The frequent incorrect use of Spiriva and Foradil capsules has prompted the Food & Drug Administration (FDA) to issue a Public Health Advisory about the correct way to use these drugs.

Spiriva, manufactured by Pfizer and Boehringer Ingelheim Pharmaceuticals,  is a once-daily inhaled maintenance prescription treatment for chronic obstructive pulmonary disease (COPD).  Foradil, marketed by Schering-Plough and Novartis AG, is approved to treat COPD, Asthma and Exercised-Induced Bronchospasm.

According to the FDA Public Health Advisory, 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, 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.

The FDA said in its Public Health Advisory that both the agency 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 FDA has advised doctors, nurses, and pharmacists to discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer. The FDA also said that  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.


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