Warning: 4 Popular Asthma Drugs: Advair, Symbicort, Serevent, Foradil: but Debate Remains

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Warning Given on Use of 4 Popular Asthma Drugs, but Debate Remains

By GARDINER HARRIS

<http://www.nytimes.com/2008/12/06/health/policy/06allergy.html>http://www.nytim\

es.com/2008/12/06/health/policy/06allergy.html

WASHINGTON ­ Two federal drug officials have

concluded that asthma sufferers risk death if

they continue to use four hugely popular asthma

drugs ­ Advair, Symbicort, Serevent and Foradil.

But the officials’ views are not universally shared within the government.

The two officials, who work in the safety

division of the Food and Drug Administration,

wrote in an assessment on the agency’s Web site

on Friday that asthma sufferers of all ages

should no longer take the medicines. A third

drug-safety official concluded that Advair and

Symbicort could be used by adults but that all

four drugs should no longer be used by people age 17 and under.

Dr. Badrul A. Chowdhury, director of the division

of pulmonary and allergy products at the agency,

cautioned in his own assessment that the risk of

death associated with the drugs was small and

that banning their use “would be an extreme

approach” that could lead asthmatics to rely on other risky medications.

Once unheard of, public disagreements among

agency experts have occurred on occasion in

recent years. The agency is convening a committee

of experts on Wednesday and Thursday to sort out

the disagreement, which has divided not only the

F.D.A. but also clinicians and experts for more than a decade.

Sudden deaths among asthmatics still clutching

their inhalers have fed the debate. But trying to

determine whether the deaths were caused by

patients’ breathing problems or the inhalers has proved difficult.

The stakes for drug makers are high. Advair sales

last year were $6.9 billion and may approach $8

billion this year, making the medication

GlaxoKline’s biggest seller and one of the

biggest-selling drugs in the world. Glaxo also

sells Serevent, which had $538 million in sales

last year. Symbicort is made by AstraZeneca and Foradil by Novartis.

Whatever the committee’s decision, the drugs will

almost certainly remain on the market because

even the agency’s drug-safety officials concluded

that they were useful in patients suffering from

chronic obstructive pulmonary disease, nearly all of whom are elderly.

Dr. Katharine Knobil, global clinical vice

president for Glaxo, dismissed the conclusions of

the agency’s drug-safety division as “not

supported by their own data.” Dr. Knobil said

that Advair was safe and that Serevent was safe when used with a steroid.

Michele Meeker, a spokeswoman for AstraZeneca,

said that the F.D.A.’s safety division improperly

excluded most studies of Symbicort in its

analysis, and that a review of all of the

information shows that the drug does not increase

the risks of death or hospitalization.

Dr. Frattarelli, a Detroit pediatrician

and member of the American Academy of

Pediatrics’s committee on drugs, said that he was

treating children with Advair and that his

committee had recently discussed the safety of the medicines.

“Most of us felt these were pretty good drugs,”

Dr. Frattarelli said. “I’m really looking forward

to hearing what the F.D.A. committee decides.”

About 9 percent of Advair’s prescriptions go to

those age 17 and under, according to Glaxo. Ms.

Meeker could not provide similar figures for Symbicort.

In 1994, Serevent was approved for sale, and the

F.D.A. began receiving reports of deaths. A

letter to the New England Journal of Medicine

described two elderly patients who died holding

Serevent inhalers. Glaxo warned patients that the

medicine, unlike albuterol, does not work

instantly and should not be used during an attack.

In 1996, Glaxo began a study of Serevent’s

safety, but the company refused for years to

report the results publicly. In 2001, the company

introduced Advair, whose sales quickly

cannibalized those of Serevent and then far surpassed them.

Finally in 2003, Glaxo reported the results of

its Serevent study, which showed that those given

the medicine were more likely to die than those

given placebo inhalers. Glaxo said problems with

the trial made its results impossible to interpret.

Asthma is caused when airways within the lungs

spasm and swell, restricting the supply of

oxygen. The two primary treatments are steroids,

which reduce swelling, and beta agonists, which

treat spasms. Rescue inhalers usually contain

albuterol, which is a beta agonist with limited

duration. Serevent and Foradil are both beta

agonists but have a longer duration than

albuterol and were intended to be taken daily to prevent attacks.

Advair contains Serevent and a steroid.

Symbicort, introduced last year, contains Foradil

and a steroid. In the first nine months of this

year, Symbicort had $209 million in sales.

The problem with albuterol is that it seems to

make patients’ lungs more vulnerable to severe

attacks, which is why asthmatics are advised to

use their rescue inhalers only when needed. The

long-acting beta agonists may have the same risks.

But drug makers say this risk disappears when

long-acting beta agonists are paired with

steroids. The labels that accompany Serevent and

Foradil instruct doctors to pair the medicines with an inhaled steroid.

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Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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