Cerner Enviza, an Oracle-owned company, and John Snow Labs are now supporting the US Food and Drug Administration’s (FDA) drug safety Sentinel Initiative. By using novel artificial intelligence (AI) tools for drug safety and real-world evidence (RWE) studies, the two companies will help the FDA improve the understanding of the effects of medicines on real-world populations.
Specifically, this two-year project aims to investigate the possible mental health side effects of Singulair (montelukast) in asthma patients who take the medicine. By using natural language processing (NLP) technology and machine learning to extract critical information from clinical notes within electronic health records (EHRs), Cerner Enviza and John Snow Labs will work together to explore the safety of montelukast on large populations.
Manually analyzing patient symptoms and outcomes from clinician notes in large populations can be a slow and labor-intensive process. By enhancing computerized queries of digital patient data and clinical notes, this scalable and transportable NLP technology will overcome the bottleneck of traditional manual methods. Therefore, the safety of montelukast as well as its relationship to mental health side effects can be explored more efficiently.
“This is an incredible opportunity to work with these exceptional leaders to use Oracle’s de-identified EHR data to help transform unstructured clinical notes into validated and useable data for physicians and researchers,” said Mike Kelly, global head, Cerner Enviza. “Connected technologies and unified data can accelerate innovation and, in turn, help providers realize better recommendations and outcomes for their patients.”
Cerner Enviza is a healthcare company headquartered in New York that specializes in life sciences data analysis and research. John Snow Labs is an American AI and NLP leader providing software, models and data consulting services for healthcare and life sciences industries.
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Singulair (Montelukast) For Asthma: How It Works and Side Effects
Merck’s Singulair (montelukast) was first FDA-approved in 1998 for the prophylaxis and chronic treatment of asthma. At the beginning of 2003, it was approved by the FDA for the treatment of seasonal allergic rhinitis. Therefore, montelukast has been used to treat asthma and allergies for over two decades now.
Montelukast is an oral medication that comes in tablets or granules and can be rapidly absorbed following oral administration. It is extensively metabolized in the body, with most of the drug being excreted via bile.
While the root causes of asthma are not yet fully understood, a combination of genetic and environmental factors, such as allergies, air pollution, obesity, smoking, viral infections and stress, are believed to contribute to its development.
According to the World Health Organization (WHO), around 262 million people worldwide were affected by asthma in 2019, and it caused about 455,000 deaths.
Chronic asthma is often caused by eosinophils that are attracted to the bronchioles by leukotrienes. Leukotrienes are inflammatory molecules released by mast cells during an asthma attack. These leukotriene-mediated effects can result in airway edema and bronchoconstriction during the inflammatory process.
Montelukast sodium, the active ingredient in Singulair, is a leukotriene receptor antagonist that prevents the release of leukotrienes from mast cells and eosinophils, and blocks specific leukotriene receptors on bronchial tissues. This reduces the influx of eosinophils to the airway and the inflammatory effect.
Possible side effects of montelukast include changes in behavior and mood, upper respiratory infections, fever, headache, sore throat, cough, stomach pain, diarrhea, earache, ear infections, flu, runny nose and sinus infections.
Does Singulair (Montelukast) Affect Mental Health?
In 2020, the FDA issued a new warning about potential mental health side effects — including suicidal thoughts or actions — in patients taking montelukast. After reviewing case reports, observational and animal studies in the published literature, and further evaluating the benefits and risks, the FDA decided to strengthen the warnings by adding a boxed warning to the prescribing information of montelukast.
The FDA advises healthcare providers to consider the benefits and risks of mental health side effects before prescribing montelukast. The FDA also says that healthcare providers should be aware that some patients have reported neuropsychiatric events after stopping montelukast use.
The FDA investigated 82 cases of suicide that could be associated with montelukast, and it was reported that many of these cases developed concomitant neuropsychiatric symptoms prior to the event; however, more than half of these cases did not have enough data for the FDA to conclude that the adverse events were directly related to montelukast. The remaining cases indicated that other additional risk factors might have contributed to suicide.
Another study conducted by the FDA compared the risk of depressive disorders, self-harm and suicide in patients taking montelukast for asthma with those taking inhaled corticosteroids (ICS). No significant risks were found in the montelukast group alone or compared to the ICS group.
In a cohort study published in JAMA Network Open, 154,946 patients with asthma or allergic rhinitis, of whom 77,473 individuals were exposed to montelukast, were recruited to investigate the association between montelukast and incident neuropsychiatric diagnoses. Increased odds of adverse neuropsychiatric outcomes, such as anxiety disorder, insomnia and prescriptions for antidepressants, were observed with montelukast treatment; however, no direct biological evidence of montelukast-associated neuropsychiatric outcomes was identified, and it was difficult to exclude other complicating factors that contributed to the neuropsychiatric diagnoses.
Overall, whether montelukast can cause neuropsychiatric events or suicide is still inconclusive. Therefore, Cerner Enviza and John Snow Labs will hopefully be able to use AI to better understand the link between montelukast and mental health side effects.
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