Breaking News
May 24, 2018 - Tau mutations may serve as novel risk factor for cancer
May 24, 2018 - Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer
May 24, 2018 - Nurse dead in Congo as Ebola vaccination campaign starts
May 24, 2018 - Unique imaging technique identifies biomarkers of cellular damage done by diabetic retinopathy
May 24, 2018 - Study identifies key food allergy policies that parents want in schools to improve safety of kids
May 24, 2018 - Formaldehyde risk found to be higher in e-cigarettes than originally thought
May 24, 2018 - NIH commences first-in-human trial evaluating experimental treatment for Ebola
May 24, 2018 - Study finds no link between surveillance intensity and detection of recurrence or survival in CRC patients
May 24, 2018 - FDA Alert: Oral Over-the-Counter Benzocaine Products: Drug Safety Communication
May 24, 2018 - Fiber-fermenting bacteria improve health of type 2 diabetes patients
May 24, 2018 - Higher exposure to carbon monoxide in utero increases risk of poor lung function in infants
May 24, 2018 - Neurologists identify new type of vertigo
May 24, 2018 - Scientists identify new inherited neurodevelopmental disease
May 24, 2018 - New family support program improves patient-centered care and lowers hospitalization costs
May 24, 2018 - Researchers take important step toward finding protein biomarkers during cancer surgery
May 24, 2018 - Deadly form of black lung disease found to be increasing among U.S. coal miners
May 24, 2018 - Robust Immune Responses for Herpes Zoster Subunit Vaccine
May 24, 2018 - Optical Coherence Tomography | Texas Heart Institute
May 24, 2018 - Type 2 diabetes slowly rising in Auckland kids – Pacific and Māori have highest rates
May 24, 2018 - Study explores brain chemistry of alcohol exposure in people with family history of AUD
May 24, 2018 - Study shows AVATS procedure as safe, effective alternative for patients deemed ‘inoperable’
May 24, 2018 - Comparative Analysis of a Complex Monoclonal Antibody
May 24, 2018 - Penn investigators discover source of immune molecule involved in nasal polyps, asthma
May 24, 2018 - Berries and Grapes May Keep You Breathin’ Easy
May 24, 2018 - Access and utilization of dental services for Medicaid children 2013-2015
May 23, 2018 - New research raises concern about rate of postpartum hemorrhage
May 23, 2018 - Researchers create new modeling framework that takes a zoonotic perspective on Ebola
May 23, 2018 - Study compares bacteria in humans to the laboratory
May 23, 2018 - Frequent sauna bathing reduces risk of stroke
May 23, 2018 - Landmark trial to test implantable defibrillator in diabetic patients with history of heart attack
May 23, 2018 - Vitamin C consumption may reduce harm to baby’s lungs due to smoking during pregnancy
May 23, 2018 - Researchers complete genomic map of chronic lymphocytic leukemia
May 23, 2018 - Medical students take to the streets to learn about real world problems at the root of poor health
May 23, 2018 - New efforts to curb high blood pressure in Asia
May 23, 2018 - Malaria-causing parasite seeks refuge inside the liver to replicate and survive
May 23, 2018 - Slower rates of stimulation may be more effective in brain therapy, suggests research
May 23, 2018 - Study finds connection between one partner’s BMI and other spouse’s risk of developing diabetes
May 23, 2018 - Mapping the Genes Responsible for Pluripotency
May 23, 2018 - FDA Alert: Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall
May 23, 2018 - Genetic fixer-uppers may predict bladder cancer prognosis
May 23, 2018 - Investigational technology could increase donor organ supply for lung transplants
May 23, 2018 - Prediabetic patients with OSA could lower their resting heart rates by using CPAP
May 23, 2018 - Schizophrenics’ blood samples feature genetic material from more types of microorganisms
May 23, 2018 - Subtle hearing deficits can change the brains of young people
May 23, 2018 - New study shows increased rates of hospitalization for suicide among youths
May 23, 2018 - Proportion of Drug-Intoxicated Organ Donors on the Rise in U.S.
May 23, 2018 - Using virtual biopsies to improve melanoma detection
May 23, 2018 - Compassion meditation training may increase brain’s resilience to suffering of other people
May 23, 2018 - New AAD PSA uses social media imagery to highlight tanning hazards
May 23, 2018 - Frequent MRSA surveillance could contain infection in newborns, study finds
May 23, 2018 - Medicaid expansion linked to reduction in ICU utilization
May 23, 2018 - Proteins moderating nicotine dependence may help fat cells burn energy
May 23, 2018 - Researchers identify mechanisms that regulate mammary gland development
May 23, 2018 - ‘Low-Alcohol’ Booze Labels May Backfire
May 23, 2018 - Social isolation could increase risk of death, hospitalizations for heart failure patients
May 23, 2018 - New research shows that children with autism are able to create imaginary friends
May 23, 2018 - New technology could make prosthetic use more intuitive and reliable
May 23, 2018 - HU researchers explore how simulated microgravity affects gene expression, muscle cell differentiation
May 23, 2018 - Researchers develop injectable bandage to stop fatal blood loss, activate wound healing
May 23, 2018 - Exercising for 4-5 days per week is needed to keep the heart young
May 23, 2018 - Porvair Sciences offers wide range of reagent reservoirs for use with automated liquid handling systems
May 23, 2018 - New study unravels secrets of HIV’s persistence
May 23, 2018 - IDF launches initiative to improve health services for displaced people with diabetes
May 23, 2018 - Maintaining healthy weight between early adulthood and middle age could help avoid diabetes
May 23, 2018 - DNA vaccine shows promise for colorectal cancer
May 23, 2018 - Abnormal brain connections seen in preschoolers with autism
May 23, 2018 - Study finds increase in number of calls to US Poison Control Centers about ADHD medication exposures
May 23, 2018 - Yoghurt before a meal packed with health benefits
May 23, 2018 - New tool predicts the lifetime risk of Alzheimer’s
May 23, 2018 - Scientists reveal mechanisms that may help preterm infants extend nephron development window
May 23, 2018 - Unnecessary antibiotic use for asthma exacerbations linked to increased hospital stays, costs
May 23, 2018 - Quitting cigarettes linked to better lung health than long-term light smoking
May 23, 2018 - Researchers shed light on how androgen deprivation therapy increases risk for cardiovascular mortality
May 23, 2018 - Ingesting blue dye tablet during colonoscopy aids in detecting difficult-to-see polyps
May 23, 2018 - Patients with low-back pain benefit from early physical therapy
May 23, 2018 - Researchers discover link between tuberculosis and Parkinson’s disease
May 23, 2018 - FDA Approves Doptelet (avatrombopag) for Chronic Liver Disease Patients with Thrombocytopenia who are Undergoing a Medical Procedure
May 23, 2018 - Is knee pain linked to depression?
May 23, 2018 - Research team uncovers new information that more accurately explains formation of tumors
May 23, 2018 - Brain stimulation shows promise in treating obesity by reducing food cravings
FDA Alert: Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication

FDA Alert: Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication

image_pdfDownload PDFimage_print

December 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). 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[12/20/2017 – Drug Safety Communication – FDA]

Tagged with:

About author

Related Articles