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

[Guest guest]

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

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.

..

--------------------------------------------------------

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

Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales

UK

Vaccines -

http://www.wellwithin1.com/vaccine.htm Vaccine Dangers &

Childhood Disease & Homeopathy Email classes start in December

2008