reports today that a US FDA panel has concluded that the risks of two asthma
drugs outweigh the benefits of their usage in children and adults.
two drugs of concern are GlaxoSmithKline PLC 's (GSK) asthma drug Serevent as
well as Novartis AG's (NVS) and Schering-Plough Corp.'s (SGP) Foradil.
the panel did not recommend that the FDA revoke its approval of these drugs for
being marketed and sold in the United States.
some members said among other things that the labels need to be modified to
tell doctors to use Serevent and Foradil with an inhaled corticosteroid, as
recommended by the current guidelines.
Co-use of corticosteroid seems to reduce risks.
The following is cited from the FDA
for those who are interested in knowing more about these drugs.
Advair Diskus, Advair HFA, Brovana,
Foradil, Perforomist, Serevent Diskus, and Symbicort Information
(Long Acting Beta Agonists)
On November 18, 2005, FDA alerted
health care professionals and patients that several long-acting bronchodilator
medicines have been associated with possible increased risk of worsening
wheezing (bronchospasm) in some people, and requested that manufacturers update
warnings in their existing product labeling. This information has now been
included in updated labeling.
On March 2, 2006, FDA approved new
safety labeling and Medication Guides for patients for Serevent Diskus (salmeterol
xinafoate) and Advair Diskus (fluticasone propionate; salmeterol
xinafoate). On June 19, 2006, FDA approved new safety labeling and a
Medication Guide for patients for Foradil (formoterol fumarate), and also
approved Advair HFA. Symbicort Inhalation Aerosol (budesonide; formoterol
fumarate dihydrate) was approved on July 21, 2006. Perforomist Inhalation
Solution (formoterol fumarate) was approved May 11, 2007.
March 5, 2008 Update: On November 28, 2007, a Pediatric Advisory Committee (PAC)
meeting was held. At this meeting, FDA raised concerns about the safety
of long-acting beta2 adrenergic agonists (LABAs) in pediatric patients with
asthma. The PAC has agreed with an FDA recommendation to continue
assessment of the risks of LABAs and seek advice from a future advisory
In January, 2008 FDA requested
manufacturers of Advair Diskus, Advair HFA, Brovana Inhalation Solution,
Foradil Aerolizer, Perforomist Inhalation Solution, Serevent Diskus, and
Symbicort Inhalation Aerosol to provide information regarding controlled
clinical studies conducted with these products in order to further evaluate the
safety of LABAs when treating asthma.
The manufacturers have indicated it
will take several months to submit the requested information. Following review
of this information, FDA plans to bring the issue of the benefit/risk
assessment of LABAs in adults and children to an advisory committee in the fall
or winter of 2008.
Labels and Medication Guidesfrom [email protected] (Medication Guides can be found at
the bottom of the labels)
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