Alert on Long Acting Beta Agonists (Bronchodilators)
Taken from letter written by Dr. Goldstein dated November 2005 and updated 2/20/10 concerning FDA alert
NEWEST UPDATE: February 2010
FDA Mandates New Safety Controls for Long-Acting Beta Agonists
Robert Lowes
February 18, 2010 ( UPDATED February 19, 2010 ) — The US Food and
Drug Administration (FDA) announced today that manufacturers of
long-acting beta agonists (LABAs) must now state on product labels
that asthma patients must not take LABAs on a long-term basis unless
their condition cannot be adequately controlled with other medications
such as inhaled corticosteroids.
The labels also must state that the LABAs should never be used alone in
the treatment of asthma in adults or children. Instead, they should be
combined with an asthma "controller" medication.
Roughly 95% of asthma patients using an LABA receive it in combination
with a corticosteroid in a single inhaled product such as Advair Diskus,
Advair HFA, or Symbicort, according to the FDA.
Advair Diskus and Advair HFA both contain a LABA called salmeterol
(Severent), and Symbicort contains the LABA formoterol (Foradil).
These LABAs, along with arformoterol (Brovana), are also marketed as
stand-alone medications.
Under the agency's new safety controls, LABA manufacturers must state
on product labels that pediatric and adolescent patients who need a
LABA in addition to a corticosteroid should be prescribed one of these
combination products, as opposed to 2 separate drugs, to ensure medication compliance.
As a result of the new warnings labels required by the agency, patients who gain control of their
asthma through these combination corticosteroid products need to be switched to a corticosteriod
alone or some other controller medication, with no LABA added.
Recent analyses of clinical trials show that LABAs are associated with a higher risk of severe
worsening of asthma symptoms, resulting in hospitalization, intubation, and sometimes death for adults
and children alike, according to the FDA.
"We think the greater public health benefit is to reduce the use of LABAs, but keep them available for
patients who really need them," said John Jenkins, MD, director of the Office of New Drugs in the FDA's
Center for Drug Evaluation and Research at a news conference today. "There is still a benefit to these
drugs for patients who aren't absolutely controlled on asthma-control medications."
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Dated 2005
Dear Athletes, Coaches, and Parents:
As a team physician for your club- I am motivated to keep you up to date on the sports medicine literature, advancements, and alerts that may
impact your sport. Occasionally, word of mouth may not be sufficient to get information out, and a provider on the wellbody team may wish to
broadcast the information in a more efficient manner. Please forward this email to your team.
In the SMART study, there was an increased risk of death (compared to placebo) in participants on long acting bronchodilators- especially in African
Americans. It is believed that using long acting bronchodilators for long periods of time (this does not include fast acting Albuterol) may
"downregulate" receptors in the lungs needed to capture Albuterol and in an emergency (asthma attack), the fast acting albuterol
(Ventolin/Proventil) may not work as effectively. This "downregulation" of a response to a drug being very effective at first and then decreasing
effectiveness after time is called "tachyphylaxis". The SMART study did have some flaws- and important questions remain unanswered including
what protection the inhaled steroid component of Advair may have to prevent risk, was the study comparable to "real-life" asthma regimens, why
were African Americans more at risk, and if indeed tachyphylaxis was the cause of death.
Asthma is a dangerous problem. Its management is clearly explained for clinicians by the National Institute of Health (NIH) guidelines on Asthma.
There remains an art to the treatment of asthma along with the science presented by the NIH.
My clinic remains consistent in its use of the long acting bronchodilators: ADVAIR, FORADIL,
and SEREVENT. They are used during exacerbations, moderate to severe persistent asthma
where inhaled steroids alone have not demonstrated relief, and short term use in several other
scenarios.
*** Please discuss what the benefits and risks are in every medicine your physician chooses. If your child is using ADVAIR, SEREVENT, or
FORADIL, please discuss this with your medical provider. Indeed they remain important medications in the treatment of asthma- and MAY BE
APPROPRIATE in your child's case. Your medical provider understands your individual case and will make good decisions regarding your
individual asthma plan.
*** Lastly, it is dangerous to stop any asthma medication without first discussing with your medical provider. DO NOT STOP ADVAIR, SEREVENT, or
FORADIL or any other asthma medication unless discussed with your medical provider.
PERSONAL DISCLOSURE STATEMENT: Dr. Goldstein has no financial interest, speaking interest, secondary gain, or stock in any
asthma medications, product research, speaker's bureaus on asthma, or other pharmaceutical lobby group with asthma.
wellbody offers the most up to date information with Dr. Goldstein's medical opinion on sports care as a Board Certified Pediatrician.
EVERY case is different and should be discussed with your medical provider.
Thank you and Happy Thanksgiving
Dated November 2005, Dr. Randy Goldstein
| For more information on this topic refer to: 2002 NIH Guidelines with 2007 Updates: http://www.nhlbi.nih.gov/guidelines/asthma/index.htm |
| My recommendations have been and remain the same: 1. Diagnose asthma with spirometry (a breathing test) and symptom history. NOT everyone who breathes hard has asthma- and, some people who merely cough (and never wheeze) actually do have asthma. 2. Use the right medications- NOT everyone with asthma needs the same regimen of medicines. For some, Albuterol before exercise is all that is necessary. For others, it may not be sufficient- and daily preventative medications are needed. 3. Inhaled steroids such as Flovent, Qvar, Pulmicort, and Asmanex are often sufficent to control symptoms and increase spirometry numbers in mild to moderate persistant asthmatics. 4. During asthma exacerbations, illness, decreased spirometry numbers, increased symptoms, ADVAIR or SYMBICORT remain important drugs- and should be used for short periods of time, and monitored carefully. Medications should be monitored closely and managed by spirometry and symptom history. Symptom history includes from earliest hint to most obvious symptom: Night time cough, Exercise intolerance, and lastly Wheeze. |
| What Researchers have learned since '05 (2008) 1. Why more deaths in African Americans? Albuterol tachyphlaxis may be more common in certain people (those with Arg/Arg receptors (1/4 of African Americans vs. 1/6 of general population) 2. Is my child at risk if on a long acting beta agonist (LABA)? It appears that patients with moderate to severe asthma that are NOT well controlled or are using short acting albuterol often or are not on an inhaled steroid with the LABA are at most risk. 3. What is the bottom line? The decision to use a long acting beta agonist should be considered a) moderate to severe asthmatic- not in a mild asthmatic in most instances b) Inhaled steroid is not helping, still needing frequent albuterol or having asthma symptoms such as night time cough or activity cough/wheeze/shortness of breath c) Once on a long acting beta agonist, does not mean ALWAYS will need one, revisit medication needs at least two to three times a year GOOD FOLLOW UP WITH YOUR HEALTH CARE PROVIDER IS THE KEY!! |
