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Published on 3 March 2008

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FDA warning over respiratory drugs

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The Food and Drug Administration (FDA) has issued a warning over the drugs used by patients suffering from chronic obstructive lung disease, including chronic bronchitis and emphysema.

The watchdog released a Public Health Advisory on the correct use of Spiriva and Foradil capsules.

The medications are designed to be inhaled through the Spiriva HandiHaler and Foradil Aerolizer inhalation devices to help patients with breathing problems.

But the FDA and the American Association of Poison Control Center’s (AAPCC) National Poison Data System have received reports of patients swallowing the capsules rather than putting them in the devices.

So far none of the people have suffered any serious side-effects, but the regulator is warning that the capsules will not treat respiratory conditions if they are swallowed rather than inhaled.

A statement from the FDA said: “Healthcare professionals should discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer.

“Patient information includes highlighted statements noting that the capsule contents are to be inhaled and not swallowed.

“The FDA will continue to monitor reports of the incorrect use of these medications and, as needed, will continue to work with the manufacturers to improve the medications’ labelling and promote patient education for the correct use of these medications.”

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“One of the most important functions and services of the clinical pharmacist is patient education to ensure proper drug use.” – Dr Manal El-Hamamsy, Faculty of Pharmacy, Ain Sham University, Cairo, Egypt



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