The FDA issued new guidelines for taking asthma drugs because of reported health risks to the patient. Long-acting beta-agonists or LABA drugs are used to relax muscles in the lung’s airways thus improving the patient’s ability to breathe freely and reducing asthma symptoms. But a recent study showed that taking LABA drugs alone can be dangerous and can even result to deaths.

As part of the agency’s campaign for safe use of every drug approved in the market, they have directed the pharmaceutical companies to put new labels on their drugs specifically informing the patient that it should not be taken for longer periods. FDA also recommended that LABA drugs should be taken with inhalable steroids. Dr. Diane Murphy, director of the FDA’s Office of Pediatric Therapeutics said in a statement that the risks of hospitalization and poor outcomes are of particular concern for children. “Parents need to know that their child with asthma should not be on a LABA alone,” she said.

The four popular asthma drugs available are Foradil, Serevent, Advair and Symbicort. These were commonly prescribed by doctors to children and adult asthma patients because of its efficacy in controlling the symptoms. However, the studies revealed that it can also mask other symptoms which can trigger serious asthma attacks. Patients may suffer exacerbations of asthma symptoms which can lead to hospitalizations and death for asthmatic children and adults.

Salmeterol (Serevent) and Formoterol (Foradil) which are prescribed as a single agent LABA, will be prescribed in combination with an asthma controller medication such as an inhaled steroid. Additional information on the package insert of the drugs should also reflect the changes required by the FDA. The labels of each product should now contain the following warnings:

1.) LABAs should only be used long-term in patients with asthma not adequately controlled with inhaled steroids or other controller medications.
2.) The agents should be used for the shortest time possible to achieve symptom control. Once patients are no longer experiencing symptoms, LABAs should be discontinued if possible with patients maintained on controller medications alone.
3.) Children and adolescents needing a LABA should use a combination product that also contains an inhaled steroid to ensure compliance with both medications.

LABA drugs used for intermittent exercise-induced bronchospasm and chronic obstructive pulmonary disease (COPD) are not included in the directive.

Medpagetoday.com published additional information why the FDA issued the warnings. From a placebo-controlled trial called SMART, FDA said that salmeterol was associated with excess deaths at an overall rate of 8 per 10,000 patients (95% CI 3 to 13). African Americans were more prone to the risk where the excess death rate was 27 per 10,000 (95% CI 8 to 46). 60,000 patients who used salmeterol and formoterol suffered from side effects with a composite of hospitalizations, intubations, and deaths. The excess rate was recorded at 28 per 10,000 patients (95% CI 11 to 45). The study also found out that the case is more prevalent in adolescents and children at 58 cases per 10,000 and children 148 cases per 10,000 respectively.

Product recalls is not necessary according to the FDA since the benefits of the drugs still outweigh the risks involved. John Jenkins, MD, director of the FDA’s Office of New Drugs said that their concern is the benefit of the greater public and the action of the agency will reduce the use of LABA’s. These drugs are still available for patients who need additional therapy.

The agency also suggested that manufacturers must develop risk evaluation and mitigation strategies. New medication guide should be given to patients while healthcare professionals should be given enough education on the appropriate use of LABAs.

The FDA will monitor the prescribing patterns for long-acting beta-agonists (LABA) drugs to determine if these are still prescribed as a solo treatment. “If we find this is still happening, we can work with our partners [in the Safe Use Initiative] to directly provide information to those practitioners and patients to make sure they have the knowledge needed to use these drugs safely,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. The “Safe Use Initiative” is a collaboration of physicians, hospitals, pharmacies, insurers, and other groups to reduce preventable harms associated with drugs. It tackle issues such as medication errors and abuse as well as adverse biological effects of drugs in normal use.

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