BehindTheMedspeak: Inhale — Don't Swallow

Today's Wall Street Journal is the only major news outlet that carried a story about the FDA's just–issued warning to health–care professionals about inadvertent misuse of two asthma medications, Foradil (above) and Spiriva (below).

It seems that the FDA has received 30 reports of people swallowing their Foradil capsules instead of placing them in their Aerolizer for inhalation.

So far there have been two reports to the agency of people ingesting their Spiriva instead of inhaling it.

The FDA said that of the 32 total incidents, one person reported breathing difficulty after swallowing a capsule and another was hospitalized with breathing problems.

A third person died but the agency said that was unrelated to the misuse.

Or so the manufacturer would have it believe, no doubt.

The FDA said both producs resemble capsules that are typically taken orally and that neither product prominently displays a "not for oral use" warning.

Changes in labeling and packaging are in progress.

Here's the story, by Jennifer Corbett Dooren.

Warning Sounded Over Incorrect Use Of 2 Asthma Drugs

The Food and Drug Administration warned of the inadvertent misuse of two asthma medications.

The agency said some consumers accidentally swallowed the medications rather than consuming them with an inhalation device.

The FDA posted an alert to health-care professionals on its Web site.

The agency said it has received 30 reports concerning the inadvertent oral use of Foradil Aerolizer, made by Switzerland-based Novartis AG and two reports of accidental misuse of Spiriva HandiHaler, made by Germany-based Boehringer Ingelheim.

Foradil products are marketed in the U.S. by Schering-Plough Corp. of Kenilworth, N.J. Representatives from Boehringer weren't available to comment.

Officials in the U.S. office of Novartis had not seen the FDA letter and couldn't immediately comment on it.

The FDA said of the 32 reports, one person reported breathing difficulty after swallowing a capsule rather than inhaling it and another patient was hospitalized with breathing problems.

There was also one reported death, but the agency said it was unrelated.

The FDA said both products resemble capsules that are typically taken orally and that neither product prominently displays a "not for oral use" warning or prominently states they are for "inhalation use only."

The FDA said it is working with both manufacturers to make labeling and packaging changes.

For now, the FDA recommends that pharmacists dispense the capsules and the inhalation device together.

The agency also recommends if the capsules and devices are dispensed separately that the capsules be affixed with a label stating, "For inhalation use with a special inhaler only."

The FDA approved Foradil Aerolizer in February 2001 for scheduled maintenance treatment of asthma and chronic obstructive pulmonary disease as well as for the prevention of exercise-induced bronchospasm on an as-needed basis.

Spiriva HandiHaler was approved in January 2004 for the scheduled, maintenance treatment of asthma and chronic obstructive pulmonary disease.