FDA Panel: 3 Asthma Drugs Can Stay
At Issue: Concern That Drugs May Increase Risk of Asthma Attacks
July 13, 2005 -- An FDA advisory panel recommended Wednesday that three
popular asthma drugs -- Serevent, Advair, and Foradil -- continue to be sold in
The FDA often follows the advice of its advisory panels, but it's not
required to do so.
All three drugs are long-acting medications. Serevent and Advair contain an
active ingredient called salmeterol.
Foradil has a different active ingredient but is in the same class of drugs.
Panelists stopped short of recommending a "black box" warning for
Foradil, which is the most serious type of warning placed on prescription
medications. That type of warning now appears on the labels of Serevent and
But the panel recommended that Foradil's package insert mention possible
safety concerns because Foradil is in the same class of drugs.
In August 2003 the FDA added a black box warning to Serevent and Advair.
At the time, the FDA stated that the warning label for Serevent and Advair
was based on a "small but significant increased risk of life-threatening
asthma attacks or asthma-related deaths seen in patients taking salmeterol in a
recently completed U.S. study."
The 28-week study was halted in January 2003 by Serevent's maker,
FDA safety reviewer David Graham, MD, voiced concern about Serevent -- as
well as other drugs unrelated to asthma -- during congressional drug safety
hearings last November.
The FDA asked for the panel's advice on the topic.
Regulators were concerned that the drug's warnings were not strong or
specific enough because of data suggesting that the drug's risks may be higher
Today, experts expressed worry about the results in blacks but said they
don't have enough evidence to make a more specific warning about the drug.
Researchers don't know whether apparent safety differences are due to genetic
factors, disparities in access to medical care, or both.
Several experts also said they were reluctant to add a race-based warning
that could drive blacks away from the drug.
Speakers at today's meeting voiced some concerns about the class of asthma
"I have significant concern that it is a class effect," said Steven
E. Gay, MD, director of pulmonary and critical care medicine at the University
of Michigan Health System and a member of the panel.
"I have concerns that until proven otherwise we have to make ourselves
believe that formoterol [Foradil's active ingredient] may act the same
way," said Gay.
"The bottom line is we have no idea one way or the other. It's just an
unknown whether formoterol would have similar findings or not," said Robert
Myers, MD, head of the FDA office responsible for evaluating respiratory
Drug Companies' Responses
Drug company officials expressed confidence in their products.
Serevent and Advair are both made by GlaxoSmithKline. Foradil is made by
Novartis and marketed in the U.S. by Schering-Plough.