FDA Cracks Down on Dangerous Asthma Drugs

18 February 2010 (Last Updated February 18th, 2010 18:30)

The US Food and Drug Administration (FDA) has cracked down on the use of long-acting beta agonists (LABAs) alone as treatments for asthma in children or adults after research showed that the long-acting medicines could lead to hospitalisation or even death. Manufacturers will be required

The US Food and Drug Administration (FDA) has cracked down on the use of long-acting beta agonists (LABAs) alone as treatments for asthma in children or adults after research showed that the long-acting medicines could lead to hospitalisation or even death.

Manufacturers will be required to include this warning in the product labels of these drugs, which are used to improve a patient’s ability to breathe freely and reduce the symptoms of asthma by relaxing muscles in the lung’s airways.

The drugs involved include the single-agent products Serevent and Foradil and combination medications Advair and Symbicort, which also contain inhaled corticosteroids.

FDA Centre for Drug Evaluation and Research Division of Pulmonary and Allergy Products director Badrul Chowdhury said that although these medicines play an important role in helping some patients control asthma symptoms, their use must be limited.

“Our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalisations and death,” Chowdhury said.

The FDA will require manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids and will also seek input on the design of these studies at a public advisory committee meeting in March.

In addition to these actions, FDA will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices.

Advair and Serevent are marketed by GlaxoSmithKline, Foradil by Novartis AG and Symbicort is marketed by AstraZeneca.