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FDA Advisory on Advair Many of you have read the article posted on February 18 on Cleveland.com and on February 19 in the Cleveland Plain Dealer regarding new Food and Drug Administration (FDA) recommendations on the use of Advair and Symbicort, medications that are commonly used for the treatment of asthma. The FDA announced yesterday that it was placing new restrictions on the use of a category of medications called long acting beta agonists (LABA). In understanding what the concerns are, it is important to understand the mechanism behind asthma and the mechanism of action of the most common asthma medications. Asthma is now known as an inflammatory disease of the lungs. In more simple terms, people who suffer from asthma have twitchier or itchier airways than other individuals. When airways are so irritated, they produce more mucus or inflammatory substances, causing the typical blockages that are heard as a musical sound called wheezing. The causes of asthma are multiple including viruses, allergies, exposure to smoke and exercise but in all cases, the underlying problem is irritability and mucus plugging. There are 3 categories of medications that are used to reverse the irritation of airways found in asthma.
1. Short Acting Bronchodilators (SAB)- The classic SAB is albuterol (known under many brand
names such as Ventolin, Proventil and ProAir). Albuterol works by directly reversing the irritability of the airways. The best way to understand this is to imagine albuterol as a toothpick. If you placed a toothpick (figuratively of course) in an irritable airway, it would work quickly to keep it open but as soon as you removed the toothpick, the irritability would continue. That is how albuterol works. It works rapidly but once it wears off, the irritability returns. A newer kind of bronchodilator is called xopenex which works in a similar fashion but without a lot of the side effects (less heart racing and fussiness) of albuterol. It is also 10 times more expensive and so, is not covered by many insurance plans.
2. Inhaled steroids - Inhaled steroids (Flovent, Qvar and others) get at the underlying cause of
the wheezing process by reducing the inflammatory process. They function much like scaffolding for repair of a building. It takes longer to build scaffolding but once in place, the building is kept solidly in place. Similarly, it takes longer for inhaled steroids to work (typically 3-5 days) and they have to be maintained for about 14 days for maximum effect.
3. Singulair - This medication prevents the release of histamine which is the major cause of
The class of medications under review by the FDA are called Long Acting Bronchodilators (LABAs) which include Salmeterol (Serevent) or Formoterol (Foradil). It is about this class of medications
that the FDA has issued its highest level warning, telling physicians not to prescribe them alone without inhaled steroids because they relax muscles in the lungs without affecting the root cause of inflammation, predisposing to worsening of asthma symptoms or sudden death. For a parent to hear that last expression is very frightening. The good news is that we and most physicians have known about these concerns almost from the licensure of these drugs and HAVE NOT PRESCRIBED them for almost 6 years. Nationwide, fewer than 5% of all asthmatics are on this class of medications without inhaled steroids. What we have used quite a bit are combinations of LABAs and inhaled steroids which are prescribed under the names Advair and Symbicort. The FDA said nothing about these combinations of drugs because they are truly life saving. The current recommendations to which most pediatricians adhere are to start with SABs like albuterol and xopenex. If the child is continuing to wheeze or having coughing at night on SABs, then we add an inhaled steroid like Flovent. But we have many patients who simply need more control and those are the kids who end up on Advair and Symbicort. They have a long safety record and the FDA simply stated that health care providers be vigilant and use these medications for as short enough period as possible (months rather than years). At Senders Pediatrics, we understand that management of asthma is a balancing act. The disease itself is one of the most common causes of pediatric hospitalizations and death when it is not effectively treated. The medications that we use routinely have long safety records and there is evidence that appropriate treatment of asthma actually helps remodel the lungs and increases the likelihood that a child will outgrow the disease. We follow national standards in developing Asthma Care Plans for every patient with more than one wheezing episode and encourage you to schedule an appointment to develop and update your child's asthma care plan. Crisis is an opportunity for growth. This new FDA report has the potential to education millions on the appropriate use of asthma medications. A generation ago, children coughed all winter. Now we have diagnosed most of them with asthma, have medications that can help them breathe, sleep and conduct normal lives. (With a nod to the Vancouver Olympics: 25% of all Olympic participants have been diagnosed with asthma and are able to function at the highest levels). Thanks for your trust!
On HINI and Seasonal Flu - Just a brief update on influenza. To date, there have been no nationally reported cases of seasonal flu. The incidence of HINI cases is 2.3% of cases of doctor visits for cold like symptoms which is below the normal for this time of year. There have been a few cases in local hospitals which are suspicious for seasonal flu and so we are anticipating the onset of seasonal flu any day now. Please, if you have not had your child vaccinated against seasonal flu, call and come in this week or next so that your child can be protected. We are especially encouraging teenagers who cannot afford to miss a week of school to get their flu vaccine this week. As for H1N1, most have seen the articles in the paper about the abysmal vaccination rates for H1N1. We have plenty of the vaccine in stock (both mist and injection) and believe that your willingness to protect your child now, may help save their lives when they are elderly. On respiratory syncycial virus (RSV) - RSV has just hit the Cleveland area causing wheezing and misery especially in kids under 2 years. If your child is coughing to the point of gagging and especially, if he or she is not drinking, please give us a call. In most cases, it is not a dangerous condition but we can often help you in the office with the misery. On bacterial meningitis - Our heart goes out to the family of Andrea Robinson, a Cleveland Heights native, a freshman at Ohio University in Athens who died of meningitis yesterday. While we don't personally know the Robinson family or the details of the type of meningitis, the sudden onset and rapid decline are commonly seen in meningococcal meningitis. In general, unless there was actual physical contact with someone with meningitis, your child is safe. Local health departments in Athens will determine if anyone needs to be given prophylactic medication. The vaccine Menactra is generally protective for the most common cases of meningococcal meningitis but is unfortunately not completely protective. It is however, the best option available for children over age 11 years. There are about 350 children who die each year in this country of meningococcal meningitis. This is why Senders Research has participated in over a dozen studies over the past 5 years that seek to develop vaccines against this dread disease for use in younger children. The highest incidence of death from this disease is in infants and we have ongoing studies that are looking to wipe out this disease once and for all.
A fewexciting things going on at Senders Pediatrics:
Join Senders Pediatrics Facebook Fan Page. We would love if you would "friend us" so that we have one more way of communicating with our patients.There are also some fun things about upcoming events that you won't want to miss. Love our office?This is your chance to show your friends, family and co workers why you like Senders Pediatrics.Until February 28, 2010, we will be rewarding our patients for new referrals to our office.If you refer a new patient to our office who schedules a well child exam, you will receive a $20 Target gift certificate.There are no limitations. Follow Certified Parent Coach Amy Speidel's blog at www.parentingadvicethatworks.com
As always, thank you for your continued support of our practice. We look forward to taking care of your family's needs this spring. Sincerely, Senders Pediatrics 2054 South Green Road South Euclid, OH 44121 Phone (216) 291-9210 Fax (216) 291-9422 senderspediatrics.com
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Senders Pediatrics | 2054 S Green Road | South Euclid | OH | 44121
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