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(for moh' te rol)[Posted 12/20/2017] AUDIENCE: Pharmacy, Pulmonology, Internal Medicine, Family Practice ISSUE: FDA's most prominent warning, the Boxed Warning, about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA. A FDA review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. A description of the four trials is now also included in the Warnings and Precautions section of the drug labels. These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone. BACKGROUND: In 2011, FDA required the drug companies manufacturing fixed-dose combination drugs containing an ICS and LABA (GlaxoSmithKline, Merck, Astra Zeneca) to conduct several large, 26-week, randomized, double-blind, active-controlled clinical safety trials to evaluate the risk of serious asthma-related events when long-acting beta agonists (LABAs) were used in fixed-dose combination with an inhaled corticosteroid (ICS) compared to ICS alone in patients with asthma. FDA reviewed the results of four trials involving 41,297 patients. The results demonstrate that the use of ICS/LABA in fixed-dose combination does not result in a significant increase in the risk of serious asthma-related events compared to ICS alone. The results of subgroup analyses for gender, adolescents 12-18 years, and African Americans are consistent with the primary endpoint results. The four trials also assessed efficacy of the ICS/LABA products. The primary efficacy endpoint was asthma exacerbation, defined as a deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days, or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The results showed that the ICS/LABA combination reduced asthma exacerbations compared to ICS alone, noting that the majority of these exacerbations were those that required at least 3 days of systemic corticosteroids. This efficacy information has been added to the Clinical Studies section of the ICS/LABA drug labels. RECOMMENDATION: Health care professionals should refer to the most recently approved drug labels for recommendations on using ICS/LABA medicines (see links in Table 1 of the Drug Safety Communication, available at: http://bit.ly/2kC3Kc4,). Patients and parents/caregivers should talk to your health care professional if you have any questions or concerns. Do not stop taking your asthma medicines without first talking to your health care professional. Also read the patient information leaflet that comes with every prescription. In a large clinical study, more patients who used an asthma medication similar to formoterol experienced severe episodes of asthma that had to be treated in a hospital or caused death than patients who did not use the medication. If you have asthma, use of formoterol may increase the chance that you will experience serious or fatal asthma problems. Formoterol nebulizer solution (Performist) is used to treat chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). It should not be prescribed to treat asthma. If you have COPD and asthma, formoterol nebulizer solution should not be prescribed to treat your COPD unless you are taking another medication to control your asthma. Your doctor will only prescribe formoterol inhalation powder (Foradil) to treat asthma that is so severe that two medications are needed to control it. You should never use formoterol alone to treat asthma; you must always use it along with another asthma controller medication. Children and teenagers who need to be treated for asthma with formoterol will probably be treated with a product that combines formoterol and another medication in a single inhaler to make it easier for them to use both medications as prescribed. Because of the risks of using formoterol inhalation powder to treat asthma, you should only use this medication as long as it is needed to bring your asthma symptoms under control. Once your asthma is controlled, your doctor will probably tell you to stop using formoterol inhalation powder but continue using the other asthma medication. Do not use formoterol inhalation powder or nebulizer solution if you have asthma that is quickly getting worse. Tell your doctor if you have had many severe asthma attacks or if you have ever been hospitalized because of asthma symptoms. If you have any of the following signs of worsening asthma, call your doctor immediately: