Skip to comments.FDA wants stronger asthma drug warnings
Posted on 11/20/2005 3:44:00 PM PST by neverdem
WASHINGTON -- The Food and Drug Administration warned Friday that three asthma drugs may increase the risk of severe asthma attacks and even death.
The agency asked the manufacturers of Advair, Serevent and Foradil to strengthen the warning labels to reflect this risk.
The FDA said that even though the drugs decrease the frequency of asthma attacks, they can make the attacks more severe when they occur. The agency said the drugs should be prescribed only if other medicines do not control patients' asthma.
Advair had sales of $4.7 billion in 2004, making it one of GlaxoSmithKline's top-selling drugs.
The FDA cautioned patients not to stop taking the drugs without consulting their doctors. The agency asked the drug makers to update product labels and medication guides for patients and doctors outlining the dangers.
GlaxoSmithKline PLC, which also makes Serevent, issued a statement disagreeing with the FDA's public health advisory. The company said the drugs already come with sufficient safety information, though the company said it would work with the FDA to "address the differences of opinion."
Schering-Plough Corp., which markets Foradil in the United States, said it is working with the FDA to update the warning label.
"Once that is final we will be communicating with physicians," said Schering-Plough spokeswoman Mary-Fran Faraji.
The drug is manufactured by Novartis AG.
Friday's advisory was a request for new warnings. But ultimately, drugs must contain FDA-approved labels.
The FDA said a recent study found that more people using the asthma drugs died from their asthma, compared with those taking placebos, though the number of asthma deaths in the study was small.
The drugs are used for long-term control and prevention of asthma symptoms. They do not relieve sudden wheezing. Patients should use short-acting inhalers to relieve sudden wheezing, according to the FDA's public health advisory.
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Serevent, Advair, and Foradil Linked to Risk of Severe Asthma Exacerbations, Death
Yael Waknine Medscape 2005. © 2005 WebMD Inc.
Nov. 18, 2005 The U.S. Food and Drug Administration (FDA) has warned healthcare professionals regarding the increased risk of severe asthma episodes and death associated with use of inhalation powders containing long-acting beta 2-adrenergic agonists (LABA) such as salmeterol xinafoate and formoterol fumarate.
Inhalation powders included in the warning include salmeterol (Serevent Diskus, made by GlaxoSmithKline), salmeterol combined with fluticasone propionate (Advair Diskus, made by GlaxoSmithKline), and formoterol (Foradil Aerolizer, made by Novartis Pharmaceuticals Corp.).
Patients receiving these medications should be advised to seek medical attention immediately if their asthma worsens, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting system.
The warning was based on data from a 28-week clinical trial (Salmeterol Multi-center Asthma Research Trial [SMART]) in 26,355 patients, showing that addition of salmeterol to usual asthma therapy was associated with an increased risk of fatal asthma events compared with placebo (13 vs 3 deaths; 0.10% vs 0.02%). These results led to early discontinuation of the study.
Although post-hoc subpopulation analyses suggested that the relative risk (RR) of death was similar among whites (RR, 5.82; 95% confidence interval [CI], 0.70 - 48.27) and African Americans (RR, 7.26; 95% CI, 0.89 - 58.94), incidence rates were higher among African Americans.
The results from SMART were similar to those of the Salmeterol Nationwide Surveillance (SNS) study in 25,180 patients, showing the incidence of respiratory and asthma-related death to be numerically (though not statistically) greater with addition of salmeterol rather than albuterol to usual asthma therapy (12 vs 2 deaths).
Although no studies have been adequate to determine whether formoterol is also associated with an increased rate or relative risk of asthma-related death, smaller studies have linked its use to an increased incidence of serious asthma exacerbations compared with albuterol and placebo.
Healthcare professionals with asthma patients receiving these medications should be aware that LABAs are not intended as first-line therapy and should be reserved for use in those who have demonstrated an inadequate response to other asthma-controller medications such as inhaled corticosteroids.
Current guidelines from the National Heart, Lung, and Blood Institute and World Health Organization recommend inhaled corticosteroids as the first step in controller therapy, with LABAs as optional add-on therapy if low- to medium-dose inhaled corticosteroids provide inadequate relief. The FDA notes that the warning applies to use of LABAs for the long-term control and prevention of asthma symptoms. Information is not available to determine the relevance of these findings in patients using LABAs for the prevention of exercise-induced bronchospasm or long-term control of bronchospasm due to chronic obstructive pulmonary disease.
Adverse events related to the use of long-acting beta 2-agonists should be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
Reviewed by Gary D. Vogin, MD
This is exactly what my doctor and pharmacist shared with me. I use Advair every morning to maintain bronchial freedom, and Albuteral as a rescue breather.
I developed asthma in my late 40's and really had a tough time with it.Many visits to to the ER and constantly using my rescue inhaler. My allergist, who I was late coming to, prescribed Pulmicort and, for me, it'been a miracle drug. I am completely symptom free and according to my Dr. my lung function is nearly normal. I have no side effects and am amazed how it has changed my life.
Anyone else with asthma taking this medication?
That's the ticket!
I need my rescue breather a handful of times t/o the year..usually spring due to allergies.
I didn't develop asthma until moving to the Sacramento area. My husband and daughter suffer as well (seasonal and exercise induced). For 14 years now our Doc has encouraged us to relocate to a less allergy-prone area. We refuse to go back to SoCal. So...Where?!
Have you ever used Flovent? I'm curious how Advair compares. I hated Pulmicort -- nasty stuff.
Definitly would not recommend the Willamette Valley! the calapooya Indians called this area the Valley of the blue death. I was born here and since 2001 Ive developed Asthma. I have used Advair for a couple of years now and its a miracle for me,I breathe not wheeze!
I have my own nebulizer which really comes in handy when I'm desperate. I can call our Doc at home (he's a friend) if absolutely necessary, for further help.
I'm thinking coastal or mountains would be best...?
The higher elevation is always better from what ive been told. lived for a time in the high desert and was ashtma free. not sure about coastal though my aunt lives on the coast and has trouble with molds.
My step-father who had severe asthma always said to my mother that those inhalers that you come to rely on would come to bite you.ie,woundn`t work
My mother takes abuterol also
Hopefully you don`t have COPD
I was just prescribed Advair, but not for asthma. Are you saying if you use it for bronchial freedom, rather than for rescue, this does not pose the risk the FDA is addressing here?
My daughtet was a pharaceutical rep and warned me that relying ona rescue inhaler could be dangerous. I was using it all day and am now free.
Hey, what ever works.It's a nasty affliction.
What was the diagosis, if I may ask? Whether you want to tell me or not, find out the diagnosis. Some docs are strange, and they're afraid to tell their patients what the deal is.
Are you saying if you use it for bronchial freedom, rather than for rescue, this does not pose the risk the FDA is addressing here?
I didn't use the term bronchial freedom by which I assumed the poster meant that there were no respiratory symptoms. Advair is for routine daily administration. When someone becomes suddenly symptomatic, i.e. short of breath, wheezing, non-productive cough, etc. they need to have a short acting beta-2-agonist such as Proventil(albuterol) metered dose inhaler available until they can get to their doc or the emergency room for treatment and evaluation.
Go to the FDA's link for Serevent Diskus, Advair Diskus, and Foradil Information(here). Go to the Public Health Advisory section, find the Patient Information Sheet for Fluticasone propionate; Salmeterol xinafoate (marketed as Advair Diskus) and click on the link. You may want to print a hard copy.
Don't make any changes without talking to your doc.
I'm not familiar with this term. So...hoping I don't have it! :o)
Just did a quick search. Nope, can't say as I have that. Whew!