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 can not 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.
This is important advice and applies to all of us, even outside the US. This article attempts to explain why?
Asthma is a condition where the airways react to certain substances, causing a reversible narrowing of airways leading to symptoms of shortness of breath and wheeze. This is associated with chronic inflammation of the lungs.
Asthma affects 6.5% of British people and a total of 300 million worldwide. Asthma causes 4,000 deaths a year in the United States.
Medicines such as inhaled short-acting beta-2 agonists may be used to treat acute attacks and cause relaxation of the muscles in the airways.
Attacks can also be triggered by avoiding triggering factors such as allergens or and through drug treatment such as inhaled corticosteroids which reduce the background inflammation.
Long acting beta-adrenoceptor agonists are usually prescribed for moderate to severe persistent asthma patients. They are like your salbutamol inhaler – but have an extra long tail allowing the substance to hang around for longer and therefore unlike your blue inhaler last around 12 hours.
Salmeterol (Serevent) is the common prescribed long acting inhaler, although another is formoterol.
Side effects of all beta agonists are insomnia, anxiety, and tremor.
In 2005, the Food and Drug Administration (FDA) alerted health care professionals and patients that several long-acting bronchodilator drugs have been associated with possible increased risk of worsening wheezing in some people and more severe attacks of asthma. This is if these medications are taken without stereoids.
It is thought that possibly the long acting drugs mask the worsening underlining inflammation. In addition, the receptors that these drugs act on, may become less in number when the long acting drugs are used and there is in an emergency when we use the short acting beta-agonist there are less receptors to work on.
However, when you talk to people they say they use their salbutamol and their long acting inhaler and often do not take their steroid inhaler.
Why might this be?
All of you who use inhalers can instantly feel the results of beta agonists – within seconds if short acting or minutes if long acting. You can breathe easily and feel them work. Steroids take weeks to work and have no instant response though without removing the background infection – you can not control asthma.
People need to understand how their medications work to realize that the steroid inhalers are the most important way if controlling their condition (if lifestyle changes and simple measure are not effective.) People are also afraid of steroids so need to be reassured, that the low doses of these medications have minimal risks and taking low dose steroids every day, has fewer risks than if you require frequent courses of oral steroids due to poor control.
The new safety controls announced by the FDA today do not apply to these people with chronic obstructive pulmonary disease.