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FDA Safety Update: Asthma Medications

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Safety of Long-Acting Beta Agonists (LABAs) continued...

In 2005, FDA issued a Public Health Advisory that alerted health care professionals and patients that LABA medicines may increase the chance of severe asthma episodes and death when the episodes occur. In this advisory, FDA highlighted several recommendations about LABA drugs. For example, LABAs should not be the first medicine used to treat asthma.

In 2006, the manufacturers of Advair Diskus, Foradil Aerolizer, and Serevent Diskus updated product labels with these warnings. Since that time, several additional products containing LABAs have been approved, including Symbicort, Perforomist (formoterol fumarate), and Brovana (arformoterol tartrate). The labels for these products contain similar warnings regarding severe asthma episodes and death.

At a November 2007 Pediatric Advisory Committee meeting, FDA raised concerns about the safety of LABAs in children with asthma. 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 to further evaluate their safety. Following the analysis of this data, FDA plans to discuss the benefit and risk of LABAs at a public advisory committee meeting in December 2008.

Advice for patients …
Patients should understand the risks of LABAs and talk with their health care professional about their concerns.

The FDA Public Health Advisory: Advair Diskus, Advair HFA, Brovana, Foradil, Perforomist, Serevent Diskus, and Symbicort Information, may be found at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm.

Anaphylaxis and Xolair

Xolair (omalizumab) is approved for treating moderate to severe persistent asthma related to allergies in patients whose symptoms are not controlled with inhaled corticosteroids. In February 2007, FDA requested that Genentech add a boxed warning to the Xolair product label. The boxed warning emphasizes that Xolair may cause anaphylaxis, an allergic reaction that may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat.

Advice for patients …
It's important to know that patients may develop this reaction after any dose of Xolair, even if there was no reaction to the first dose. Also, anaphylaxis after administration of Xolair may be delayed up to 24 hours or more after the dose is given.

Patients who take Xolair should know the symptoms of anaphylaxis, and should also know how to initiate emergency self-treatment.

For more information about topics for your health, visit the FDA Consumer Information Center (www.fda.gov/consumer). 

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