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FDA Panel Wants Restrictions on Two Asthma Drugs

Dec 12, 2008 | Parker Waichman Alonso LLP

A U.S. Food and Drug Administration (FDA) panel has called for restrictions on two asthma treatments:  Serevent and Foradil.  Both belong to a class  of drugs known as long-acting beta-agonists.  Both contain a drug that relaxes muscles around airways, said WHEC TV, but may also mask symptoms that can prompt deadly asthma attacks.  Although the expert 27-member panel found Serevent and Foradil drugs present greater risks than benefits and should not be used in the treatment of asthma, the inhaler drugs will likely not be pulled, said WebMD Health News.

The panel suggested the FDA alert physicians to not prescribe Serevent and Foradil as a stand-alone treatment for patients of any age, said WebMD; however, the drugs’ use in chronic obstructive pulmonary disease (COPD) remains unaffected.  The panel backed Symbicort and Advair, finding the benefits were greater than the risks, added WebMD.

NBC noted that with 20 million Americans suffering from asthma, it is critical they receive appropriate treatment at the first sign of an attack, noting that the panel was reviewing the benefits and risks—such as hospitalization and death—of a variety of asthma medications.  

NBC pointed out that Advair, Serevent, Foradil, and Symbicort are all long-lasting medications that might reduce reliance on rescue inhalers.  But, an FDA study found that long-lasting drugs present a two-to-seven times greater risk over other medications for severe complications and death, especially in women, African-Americans, and children under 12. Doctors recommend, said NBC, that these drugs be used in collaboration with inhaled cortico-steroids, which treat inflammation.   In Symbicort and Advair, the steroid is built in.  Advair was the only one of the four drugs with no increased risk, reported NBC.

Angel Waldron of the Asthma and Allergy Foundation of America told NBC that, “Removing them or limiting access to them would be setting us back about fifteen years in asthma care,“ but not all experts agreed.  One recommended Serevent and Foradil be pulled and all four banned for children.  Another felt the benefits “far outweighed” the risks, said NBC, which noted of 60,000 patients studied, 20 suffered asthma-related deaths.

Medical guidelines and the drugs' labeling recommend long-acting beta-agonists only be used with inhaled steroids to minimize airway inflammation; the combination lowers risks to levels experts find acceptable, reported WebMD Health News.  But studies reveal most asthma patients tend not to use inhaled steroids as prescribed when taking them separately from beta-agonists and patients receive relief from beta-agonist inhalers, leading many to use them alone—a practice called monotherapy—which raises the drugs’ risks, according to the FDA studies, said Web MD.

"I think the label should be greatly strengthened to say that monotherapy for asthma should basically be contraindicated" for Serevent and Foradil, Daniel Notterman, MD, a member of the advisory panel from the department of molecular biology at Princeton University, told Web MD Health News.  

Notterman was not alone, and the FDA panel agreed with him in a 17-to-10 vote, saying Serevent and Foradil’s risks outweigh benefits when used alone.  The panel found voted unanimously that neither drug be used in younger children four to 11 years old, said Web MD Health News.  

"The data is that single use is dangerous," David Schoenfeld, PhD, a panelist and professor of medicine from Massachusetts General Hospital, told Web MD.  

Because Advair contains both a beta-agonist and steroids, thus reducing the risk of airway passage inflammation,  the pane backed that drug.  However, there was disagreement among panel members regarding Advair’s use in children.  The fourth drug, Symbicort, is not generally prescribed for children said Web MD.