FDA Panel: Ban 2 Popular Asthma Drugs

KEYWORDS:
• ADRENERGIC AGONISTS BETA
• ADRENAL CORTEX HORMONES
• ANTIASTHMATIC AGENTS
• ASTHMA
• BUDESONIDE
• DRUG REACTION, ADVERSE
• FLUTICASONE
• FORMOTEROL
• SALMETEROL
• UNITED STATES FOOD AND DRUG ADMINISTRATION

A panel of advisors to the US Food and Drug Administration (FDA) recommended that the agency ban the marketing of 2 popular asthma drugs that have been associated with an increased risk of rare but serious adverse events and, in some cases, death.

Asthma treatments containing long-acting β-agonists alone are associated with an increased risk of rare but serious adverse events.

(Photo credit: Ted Grudzinski/AMA)

The panel was charged with assessing the risks and benefits of certain asthma treatments, specifically the long-acting β-agonist (LABA) drugs formoterol and salmeterol and combination products containing both a LABA and an inhaled corticosteroid (formoterol plus budesonide and salmeterol plus fluticasone). Previously, the FDA’s Office of Drug Safety and the agency’s pulmonary and allergy drug products division had made contradictory recommendations concerning LABAs.

The panel, which consisted of members from 3 committees that advise the FDA on drug safety, pediatric issues, and pulmonary and allergy drugs, recommended that the …