The Centers for Disease Control and Prevention (CDC.gov) estimates that about seven million children have asthma, and this amounts to about 9.4 percent of all children. This also amounts to many parents who are curious as to what medicines are deemed safe for their children.
Since most pharmaceutical companies don’t want to risk performing studies on children under four, most studies on asthma medicines are only performed on older kids and adults. Still, the studies performed give doctors a good indicator of what medicines are safe, and what medicines work best for asthma.
It’s also interesting to note that most medicines are approved for use in other countries long before they are approved for use in the United States by the Food and Drug Administration ( FDA.gov). Likewise, most medicines are approved by the FDA for adults long before being approved for children.
This is good and bad. It’s good news for you and your children, because the FDA has the stiffest criteria for new medicines, particularly when it involves children. So usually by the time a medicine is approved by the FDA it’s been around for many years and has been deemed safe and effective.
It’s bad because there are probably options to help you and your child’s doctor improve control of your child’s asthma that the FDA won’t allow you to use.
Still, no asthma doctor wants young children to suffer from asthma while older children and adults are obtaining good asthma control with a good medicine regime. So over the years many doctors have approved medicines on young children, and with great results.
Therefore, the National Heart, Lung and Blood Institute’s asthma guidelines note that what medicines work best for your children are based on “recommendations” by experts in the field. According to the NHLBI’s asthma guidelines and the FDA.gov, the following medicines are safe for young children:
Rescue Medicine: These are medicines that give quick relief from asthma attacks by relaxing the muscles around the air passages. They are also called bronchodilators or beta 2 adrenergics. This is medicine that is used when your child’s asthma is flaring. Rescue medicine is often considered life saving devices, and the FDA and most asthma guidelines recommend all asthmatics have one nearby at all times.
- Albuterol inhaler (Ventolin, Proventil): These inhalers were approved by the FDA in 1981, and have since gone on to become the best selling asthma medicine of all time because of its ability to quickly end an asthma attack. So this medicine has been around long enough that the medical community is very familiar with its potential benefits and risks. Risks are generally negligible, and pale in comparison to not treated asthma. Although the medicine is FDA approved for use in kids aged four and up, most physicians feel comfortable using it for all age groups, according to FDA.gov. The recommended dose is 2 puffs every 4-6 hours as needed for acute episodes of asthma.
- Albuterol solution (Ventolin, Proventil): These were approved by the FDA in 1987 for children two years of age and up, although physicians generally feel comfortable using the medicine for all age groups. The recommended dose is usually 0.5cc or 2.5 mg mixed with 3cc of normal saline (or one amp) and nebulized over 5-15 minutes every 4-6 hours as needed. The dose is the same for adults and children because most of the medicine is wasted to the atmosphere. However, if side effects ensue, a lower dose may be trialed.
- Levalbuterol solution (Xopenex): It’s the newest rescue medicine on the market and was approved by the FDA in 1999. Studies are mixed as to whether it works better and has fewer side effects than Albuterol. Since it costs significantly more than albuterol, it’s usually reserved for children who exhibit side effects from albuterol. The medicine is available in three doses: 0.31 mg, 0.63 mg, and 1.25 mg, all premixed in plastic amps with 3 cc of normal saline. Studies showed the 0.63 dose was simiilar in effect to the 2.5 mg dose of albuterol. The 1.25 mg dose was believed to last from 6-8 hours, meaning less medicine would be needed during the course of the day.
- Levalbuterol inhaler (Xopenex): It was approved by the FDA in 2005 for children aged six and up, although, like albuterol, is generally considered safe for all age groups.
Asthma Controller Medicine: These are medicines that should be taken every day as directed to control and prevent asthma from flaring up. One or a combination of those listed may be prescribed for your child.
- Pulmicort (Budesonide) Respules: In 2000 this became the only inhaled corticosteroid nebulizer solution to be approved by the FDA. It’s used to reduce inflammation in the lungs and is approved for asthmatic children aged 1-8. It’s generally considered safe and effective for all age groups. Doctors like it because it works great for children who have trouble coordinating inhalers.
- Flovent (Fluticasone): Another inhaled corticosteroidal option approved for children 4 and over. The inhaler was approved by the FDA in 1996 and the dry powder Flovent Diskus in 2000.
- Advair (Salmeterol combined with Fluticasone): A combination of the long acting bronchodilator (LABA) Salmeterol and Fluticasone used to prevent asthma in children who don’t respond to inhaled corticosteroids alone. According to the FDA.gov, in August of 2000 it was approved for asthmatics 12 years of age and up. News-Medical.net reported in April 2004 that the FDA approved the lowest dose, 100/50 (Fluticasone/Salmeterol), for use on asthmatics four years of age and older. Very young children may have trouble generating enough flow to actuate the medicine. These children may benefit from the Advair HFA inhaler approved by the FDA in 2006.
- Singulair (Montelukast): This is a non steroidal option approved by the FDA in 1998. It blocks leukotrienes and prevent the allergic response and bronchoconstriction (narrowed air passages). A 4mg chewable tablet is approved for children 2-6, and 4 mg granules for kids aged 1 and over
- Symbicort (Formoterol combined with budesonide): It’s another option similar to Advair, although the LABA is fast acting and the inhaled corticosteroid may be slightly better. It is currently only approved for children 12 years of age and older. It was approved by the FDA in 2006, according to FDA.gov, and may soon be approved for younger children.
It’s important to note that determining what asthma medicine works best for your child is often based on trial and error. Likewise, you’ll want to weight the benefits with the potential risks. For most asthmatics, the risks associated with poorly controlled asthma are far greater than the risks associated with most asthma medicines.
As I mentioned above, some doctors may feel comfortable using any of these medicines on your child even when not FDA approved for that particular age group.
Of course you’ll also have to consider your child’s ability to take a certain medicine. For example, younger children may not be able to coordinate an Advair inhaler, or may not be able to generate enough flow to inhale the medicine. In this case Pulmicort might be a better option. So you’ll have to work with your child’s doctor to determine which medicine works best.
Once a medicine regime is decided upon, it will be up to you to make sure your child takes his medicine exactly as prescribed. In this way, your child should be able to live a normal, active life.
For further reading check out my post on Nebulizer or inhaler: Which one works best for my child?.
Note: This post was reviewed by James Thompson, M.D.
A Registered Respiratory Therapist and asthmatic