1 / FDA Consume r Hea l t h In fo r ma t ion / U . S . F ood and D r ug Admin i s t r a t ion
NOVEMBER 18 , 2008
Consumer Health Information
Here is a Food and Drug Adminis-
tration (FDA) update on recent safety
issues with asthma medications.
INCORRECt USE OF FORADIl
In February 2008, FDA issued a
Public Health Advisory to highlight
the correct use of Foradil capsules.
Foradil Aerolizer (formoterol fumar-
ate inhalation powder) is approved
to prevent wheezing and breath-
ing problems caused by asthma and
chronic obstructive pulmonary dis-
The medication in Foradil capsules
is specifically designed to be inhaled
through the Foradil Aerolizer inha-
lation device to deliver the medicine
to the lungs. FDA and the American
Association of Poison Control Cen-
ter’s National Poison Data System
have received reports of people swal-
lowing the capsules rather than plac-
ing them in the inhalation device.
Few patients have experienced side
effects from swallowing the capsules.
But the medication won’t work if the
of nose), and to prevent exercise-
induced asthma. Singulair is part of
a class of “anti-leukotriene” drugs.
These drugs act by blocking the activ-
ity of leukotrienes, chemicals that are
involved in airway inflammation.
In the past year, Merck & Com-
pany, Inc. has updated the patient
information for Singulair to include
these postmarketing adverse events:
tremor, depression, suicidal thinking
and behavior (including suicide), and
In March 2008, FDA issued an early
communication about an ongoing
safety review of Singulair. The agency
is investigating a possible association
between the use of Singulair and
behavior/mood changes, suicidal
thinking and behavior, and suicide.
Early communications are in keep-
ing with FDA’s commitment to inform
the public about its ongoing safety
reviews of drugs. An early commu-
nication does not mean that FDA has
concluded that there is