UPDATE 4-US FDA calls for stronger warnings on asthma drugs
Fri Nov 18, 2005 08:51 PM ET
By Deena Beasley, Reuters news service
LOS ANGELES, Nov 18 (Reuters) - U.S. regulators on
Friday asked the makers of three popular asthma medications to add new warnings to their labels stating that the drugs could
increase the chances of severe asthma episodes that could result in death. The
warnings involve long-acting bronchodilator medicines Advair and Serevent, made by GlaxoSmithKline (GSK.L: Quote, Profile, Research) , and Foradil from Novartis AG (NOVN.VX: Quote, Profile, Research) . Patients use them daily to relax bronchial muscles and prevent asthma attacks. In
a public health advisory issued on its Web site, the U.S. Food and Drug Administration said drugs in the class known as long-acting
beta 2-adrenergic agonists should only be used after other medicines fail to control asthma. The FDA said that even though
long-acting beta 2-adrenergic agonists decrease the frequency of asthma episodes, these medicines may make asthma episodes
more severe when they occur.
GlaxoSmithKline, Europe's biggest drug maker, disagreed with the proposed labeling changes, saying they were inconsistent with the standard
of care for asthma treatment, which could put many patients at risk of uncontrolled asthma.
Guidelines from the National Institutes of Health currently
recommend steroids and long-acting beta 2-adrenergic agonists, as initial therapy for moderate to severe persistent asthma.
"These proposed labeling changes would reserve the most effective asthma treatment
-- the combination of inhaled corticosteroids and long-acting beta agonists -- until after a patient has failed on other treatment
options and, therefore, may be at risk for severe outcomes, such as exacerbations and potentially death," Glaxo said in a
The new safety alert could have a material impact on
profits at Glaxo, which relies on its asthma franchise for about 15 percent of total sales, Prudential Equity analyst Tim
Anderson said in a report.
Schering-Plough Corp. (SGP.N: Quote, Profile, Research), which markets Foradil in the United States, said it is still discussing the proposed label changes with the FDA. "Safety
is the most important thing ... patients should be discussing this with their doctors," said Schering spokeswoman Mary-Fran
Asthma is a chronic lung disease that afflicts about
15 million Americans, nearly 5 million of them children. The disease can cause episodes of wheezing, coughing and breathing
difficulty. Severe asthma attacks can kill.
In July, an advisory panel to the FDA said the three
asthma drugs were safe enough to stay on the market.
Glaxo's Serevent and Advair already come with "black
box" warnings related to one study showing Serevent patients had a higher, albeit small, risk of life-threatening asthma attacks
and deaths. The panel urged that Novartis' medicine Foradil, part of the
same class of drugs, should carry a similar warning.
Worldwide sales of Advair totaled $4.5 billion last
year, making it Glaxo's top-selling product. Serevent sales were $639 million in 2004, while sales of Foradil were $320 million. Shares of Glaxo fell 4 percent to
close at $49.92 on the New York Stock Exchange, while shares of Novartis rose 0.6 percent to close at $54.19.
(Additional reporting by Julie Steenhuysen in Chicago and Pete Harrison in London and Deena Beasley in Los Angeles)
The relative silence of the press as to the harm done
by are capitalistic pharmaceutical industry for the sake of profits, while the media has banner headlines of murders, as though
one type of unnecessary death is OK, while the other isn’t, this is the result of business community owning the press. Over 50,000 people die from COX-2 inhibitors in the US and those deaths are in amount of space buried in
comparison to the 2 murders by O.J. Simpson or the death on the Space Shuttle. And
those two are the kind of events where public policy changes would have near nil effect upon similar recurrences while an
overhauling of the FDA would be quite prophylactic.