From rxpgnews.com
FDA Panel to Discuss Safety Issues With Long-Acting Beta Agonists
By FDA Advisory Committe
May 4, 2005, 08:53
FDA's Pulmonary-Allergy Drugs Advisory Committee will meet July 13 to address new safety issues with long-acting beta agonist bronchodilators.
The committee will discuss 'the implications of recently available data related to the safety' of the class, which includes Schering-Plough's Foradil (formoterol) and GlaxoSmithKline's Serevent (salmeterol).
Serevent was one of several agents singled out during a Nov. 18 Senate Finance Committee hearing on the Vioxx withdrawal as having unaddressed safety issues.
Serevent "has the unfortunate property that, I believe at least, it increases the risk of somebody that has asthma dying because of their asthma," Office of Drug Safety Associate Director for Science David Graham asserted during the meeting.
There have been reports of deterioration of asthma control and respiratory arrest with the long-acting beta agonists.
Serevent labeling includes a boxed warning that there was a "small but significant increase in asthma-related deaths" in the SMART trial. "Given the similar mechanisms of action of beta-2 agonists, it is possible that the findings seen in the SMART study may be consistent with a class effect," labeling adds.
Both Serevent and Foradil carry extensive class labeling on safety, including warnings against use in patients with worsening or deteriorating asthma and warnings regarding paradoxical bronchospasm.
There has also been concern about a heightened risk of cardiovascular complications of beta agonists' class labeling includes a warning on cardiovascular effects.
The committee is slated to discuss essential use designations for respiratory drugs on July 14.
FDA's meeting notice states "the committee will discuss the continued need for the essential use designations of prescription drugs for the treatment of asthma and chronic obstructive pulmonary disease under 21 CFR 2.125."
The agency recently issued a final rule for removal of essential use designations for CFC-containing albuterol products. The rule states that such products must be off the market by Dec. 31, 2008.
The rule is in line with the advisory committee's June 10, 2004 recommendation that withdrawal of CFC-containing albuterol products should not occur prior to Dec. 31, 2006.
The Pulmonary-Allergy Drugs committee will also meet June 6 to review Chiron's inhaled cyclosporine Pulminiq for prevention of lung transplant rejection.
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