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US FDA Panel Recommends Restrictions on Two Asthma Drugs

A U. S. Food and Drug Administration (FDA) panel has called for restrictions on two asthma drugs, Serevent and Foradil and said the widely prescribed drug Advair is safe to use.

Both drugs Serevent and Foradil belong to a class of drugs known as long-acting beta-agonists and contain a drug that relaxes muscles around airways, and which may also hide symptoms that can prompt deadly asthma attacks.

Long-acting beta-agonists are recommended to be used with inhaled steroids to minimize airway inflammation as the combination lowers risks to levels experts find acceptable. But most asthma patients tend not to use inhaled steroids as prescribed and many use them alone, a practice called monotherapy which raises the drugs' risks. "The data is that single use is dangerous," said David Schoenfeld, PhD, a panelist and professor of medicine from Massachusetts General Hospital.

The expert 27-member panel reached this decision based on evidence of asthma-related deaths and serious complications with the continued use of Glaxo's Serevent and Novartis AG's Foradil for adults, adolescents and children with asthma.

GlaxoSmithKline Plc's Advair AstraZeneca Plc's Symbicort were deemed safe with the panel unanimously backing Advair's use in adults and a 23-3 vote with one abstention for adolescents. The panelists felt there was too little data to guide them in the case of children and voted 13-11 with three abstentions on Advair's safety for children 4-11.

Dr. Fernando Martinez, director of the Arizona Respiratory Center at the University of Arizona said, "There is no doubt the advent of long-acting beta agonists has improved the lives of the majority of patients ... it would be in my opinion irresponsible to withdraw this medicine."

The panel recommended that the FDA ask physicians to not prescribe Serevent and Foradil as a stand-alone treatment for patients of any age, however, the drugs' use in chronic obstructive pulmonary disease (COPD) remains unaffected. The risks were found to be greater in women, African-Americans, and children under 12.

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

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."

Glaxo Chief Medical Officer Ellen Strahlman said the company was concerned "it is possible that Serevent would be severely restricted and deny patients needed treatment for optimal care of their asthma."

Novartis and Schering-Plough, in a joint statement, said, "We believe this opinion is inconsistent with clinical evidence," the companies said referring to the panel's finding that Foradil's risks exceeded its benefits