Asthma drug warning 12 08.pdf
Warning Given on Use of 4 Popular Asthma Drugs, but Debate Remains
By GARDINER HARRIShttp://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 touse four hugely popular asthma drugs — Advair, Symbicort, Serevent and Foradil. But the officials’ views are notuniversally shared within the government.
The two officials, who work in the safety division of the Food and Drug Administration, wrote in an assessment onthe 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 longerbe 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 hisown assessment that the risk of death associated with the drugs was small and that banning their use “would be anextreme 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. Theagency is convening a committee of experts on Wednesday and Thursday to sort out the disagreement, which hasdivided 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 whetherthe 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 GlaxoSmithKline’s biggest seller and one of the biggest-selling drugs in the world. Glaxoalso sells Serevent, which had $538 million in sales last year. Symbicort is made by AstraZeneca and Foradil byNovartis.
Whatever the committee’s decision, the drugs will almost certainly remain on the market because even the agency’sdrug-safety officials concluded that they were useful in patients suffering from chronic obstructive pulmonarydisease, nearly all of whom are elderly.
Dr. Katharine Knobil, global clinical vice president for Glaxo, dismissed the conclusions of the agency’s drug-safetydivision as “not supported by their own data.” Dr. Knobil said that Advair was safe and that Serevent was safe whenused with a steroid.
Michele Meeker, a spokeswoman for AstraZeneca, said that the F.D.A.’s safety division improperly excluded moststudies of Symbicort in its analysis, and that a review of all of the information shows that the drug does not increasethe risks of death or hospitalization.
Dr. Daniel Frattarelli, a Detroit pediatrician and member of the American Academy of Pediatrics’s committee ondrugs, said that he was treating children with Advair and that his committee had recently discussed the safety of themedicines.
“Most of us felt these were pretty good drugs,” Dr. Frattarelli said. “I’m really looking forward to hearing what theF.D.A. committee decides.”
About 9 percent of Advair’s prescriptions go to those age 17 and under, according to Glaxo. Ms. Meeker could notprovide 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 NewEngland Journal of Medicine described two elderly patients who died holding Serevent inhalers. Glaxo warnedpatients 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 surpassedthem.
Finally in 2003, Glaxo reported the results of its Serevent study, which showed that those given the medicine weremore likely to die than those given placebo inhalers. Glaxo said problems with the trial made its results impossibleto interpret.
Asthma is caused when airways within the lungs spasm and swell, restricting the supply of oxygen. The two primarytreatments are steroids, which reduce swelling, and beta agonists, which treat spasms. Rescue inhalers usuallycontain albuterol, which is a beta agonist with limited duration. Serevent and Foradil are both beta agonists but havea 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 firstnine 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 whyasthmatics are advised to use their rescue inhalers only when needed. The long-acting beta agonists may have thesame risks.
But drug makers say this risk disappears when long-acting beta agonists are paired with steroids. The labels thataccompany Serevent and Foradil instruct doctors to pair the medicines with an inhaled steroid.
Source NY Times: http://www.nytimes.com/2008/12/06/health/policy/06allergy.html?_r=1
CURRICULUM VITAE BORN: June 5th, 1953 Rome, Italy EDUCATION: 1979 POSITIONS: 1977-1983 Research Fellow in Ethology, University of Rome La Sapienza Research Psychiatrist, University of Rome Tor Vergata Professor of Psychosomatic Medicine, School of Specialization in Psychiatry, School of Medicine, University of Rome Tor Vergata Professor of Psychosomatics, School of Me
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