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General Health : Drug News Last Updated: Apr 20, 2011 - 9:38:09 AM


Two asthma drugs’ risks outweigh benefits
By Ben Wasserman
Dec 11, 2008 - 1:58:20 PM

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CNN 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.

 

The 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.

 

But the panel did not recommend that the FDA revoke its approval of these drugs for being marketed and sold in the United States.

 

Instead, 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 committee ( http://www.fda.gov/ohrms/dockets/ac/oc07.htm#pac).  

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 Guides from Drugs@FDA (Medication Guides can be found at the bottom of the labels)

·          Advair Diskus

·          Advair HFA

·          Brovana

·          Foradil Aerolizer

·          Perforomist

·          Serevent Diskus

·          Symbicort

Patient Information Sheets

·          Fluticasone propionate; Salmeterol xinafoate (marketed as Advair Diskus) [ HTML] [ PDF] (updated 5/15/2006)

·          Fluticasone propionate; Salmeterol xinafoate (marketed as Advair HFA) [ HTML] [ PDF] (posted 7/5/2006)

·          Formoterol fumarate (marketed as Foradil Aerolizer) [ HTML] [ PDF] (updated 7/5/2006)

·          Salmeterol xinafoate (marketed as Serevent Diskus) [ HTML] [ PDF] (updated 5/15/2006)

Other Information

·          Historical Information

Date created: March 3, 2006, updated April 1, 2008





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