LABA Asthma Inhaler Side Effects: FDA Issues New Usage Recommendations
The FDA has released documents announcing label changes, recommended usage guidelines and other initiatives intended to promote safe use of popular asthma drugs containing Long-Acting Beta-Agonists, (LABAs).
Package inserts for the two single-agent LABAs approved for asthma — single-ingredient products Serevent and Foradil, as well as combination medications like Symbicort — will be changed to require that the drugs are always used in combination with an asthma controller medication such as an inhaled corticosteroid.
Side Effects of Serevent, Etc. – Recommended Usage for LABAs
FDA action comes after a careful examination of recent studies suggesting that treating asthma and breathing problems with LABAs alone may lead to serious side effects, including:
- Worsening of asthma symptoms
- Heart attack
The FDA recommends the following:
- LABAs should not be used for long-term treatment of asthma
- LABAs always should be used in combination with other inhaled medications
How LABAs Work
LABAs like Serevent, Symbicort and Foradil are generally taken through an inhaler to relax the muscles of the airways, allowing unrestricted airflow to the lungs. LABA effects last for 12 hours and do not treat the sudden-onset of an asthma attack.
LABAs also may be used to relieve symptoms of a lung condition known as chronic obstructive pulmonary disease and exercise-induced bronchospasm.
Other LABAs Initiatives
In addition to the new labels, the FDA has asked the manufacturers of LABAs to begin a risk management program called Risk Evaluation and Mitigation Strategy to inform both patients and physicians of the new findings and possible health risks associated with popular LABAs.
The FDA also is demanding further clinical trials that will be conducted by the manufacturers of LABAs in order to continue studying the side effects.
However, the FDA says it believes that the drug’s benefits still outweigh the risks, which is why it is ordering a recall of the drugs.
The manufacturers of LABAs may already be facing a slew of defective drug lawsuits for failing to properly warn patients and physicians that LABAs should only be used in combination with other asthma treatments.
If you or a loved one has suffered harm as a result of LABAs, you may be entitled to monetary compensation under products liability laws. The defective drug lawyers at AWKO comprise a highly experienced staff that can help you obtain justice for your pain and suffering. To learn more, please call AWKO at (888) 225-2956.