In a Drug Safety Communication issued today, the FDA cites concerns of serious mental health side effects for montelukast, adding risks may include suicidal thoughts or actions. These include antihistamines such as loratadine (Alavert, Claritin), fexofenadine (Allegra), cetirizine (Zyrtec), levocetirizine (Xyzal), and diphenhydramine (Benadryl), as well as steroid nasal sprays such as fluticasone (Flonase), triamcinolone (Nasacort), and budesonide (Rhinocort). The ethnic/racial distribution in this study was 83.2% Caucasian, 8.1% Black, 5.4% Hispanic, 2.3% Asian, and 1.0% other origins. Epub 2021 Sep 3. Revised: Jun 2021. National Library of Medicine In many cases, symptoms resolved after stopping montelukast; however, in some cases symptoms continued after stopping. Enfermedades de Inmunodeficiencia Primaria, AAAAI Diversity Equity and Inclusion Statement. Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT1 receptor (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or -adrenergic receptor). Cochrane Database Syst Rev. NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. Montelukast is a generic drug. Courtney Blair, MD, discusses how COVID-19 has impacted patients with allergies and other respiratory conditions. For the tablets and chewable tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Chest. Before The site is secure. 2023 Mar 15. doi: 10.1007/s10266-023-00800-5. Only prescribe montelukast for allergic rhinitis in patients who have an inadequate response or intolerance to alternative therapies. government site. In fertility studies in female rats, montelukast produced reductions in fertility and fecundity indices at an oral dose of 200 mg/kg (estimated exposure was approximately 70 times the AUC for adults at the maximum recommended daily oral dose). Those taking montelukast who exhibit mood changing behaviors should immediately report symptoms to a healthcare provider. Using data from the FDAs Sentinel System from January 1, 2010, to September 30, 2015, we investigated if there is an increased risk of hospitalized and treated outpatient depressive disorders, self-harm, and suicides associated with montelukast use for asthma compared to inhaled corticosteroids (ICS). Treatments Asthma, Maintenance Montelukast Print Save Montelukast Generic name: montelukast [ mon-te-LOO-kast ] Brand name: Singulair Dosage forms: oral granule, oral tablet, oral chewable tablet Drug class: Leukotriene modifiers Medically reviewed by Carmen Pope, BPharm. Montelukast is rapidly absorbed following oral administration. Montelukast is FDA-approved for asthma and allergies. singulair (montelukast sodium) drug. SINGULAIR did not, however, prevent clinically significant deterioration in maximal percent fall in FEV1 after exercise (i.e., 20% decrease from pre-exercise baseline) in 52% of patients studied. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Regulatory Science Research and Education, Guidance, Compliance, & Regulatory Information, FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis, FDA Drug Safety Communication: FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis, FDA Drug Safety Podcast: FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis. 2009 Jan;102(1):69-75. doi: 10.1016/S1081-1206(10)60111-1. 8600 Rockville Pike On March 4, 2020 FDA strengthened existing warnings about serious behavior and mood-related changes with montelukast (brand name Singulair), a prescription medicine for asthma and allergy. You may report side effects to the FDA at 1-800-332-1088. However, there has been continued concern among stakeholders about the risk of neuropsychiatric events and the lack of awareness among prescribers and patients/caregivers. Marschallinger J, Schffner I, Klein B, Gelfert R, Rivera FJ, Illes S, et al. MeSH This content does not have an Arabic version. official website and that any information you provide is encrypted Table 8: Mean Maximum Percent Fall in FEV1 Following Exercise Challenge in Pediatric Patients (N=64) ANOVA Model. Cialis Together 10mg Tablets - Tadalafil - 4 Tablets. The results for the mean maximum percent fall at each timepoint in Study A are shown in TABLE 7 and are representative of the results from the other two studies. SINGULAIR oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration. FOIA The following adverse reactions have been identified during post-approval use of SINGULAIR. SINGULAIR has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions. Typical doses available are 5, 10 and 20 mg, with recommended starting dose from 10 mg, to be taken before sexual activity. FDA Boxed Warning for Montelukast: Impact on Adult Severe Asthmatics? 2013 Jul-Aug;41(4):216-24. doi: 10.1016/j.aller.2012.07.004. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. In many cases, symptoms resolved after stopping montelukast; however, in some cases symptoms persisted after discontinuation from therapy or were reported after discontinuation of therapy. Methods: Drug information provided by: Merative, Micromedex. We are taking this action after a review of available information led us to reevaluate the benefits and risks of montelukast use. No dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency. In patients with asthma aged 2 years and older who received SINGULAIR, a decrease in mean peripheral blood eosinophil counts ranging from 9% to 15% was noted, compared with placebo, over the double-blind treatment periods. The https:// ensures that you are connecting to the Patients who have exacerbations of asthma after exercise should have available for rescue a short-acting inhaled -agonist. I hope this dialog helps you in your practice. Daily administration of SINGULAIR for the chronic treatment of asthma has not been established to prevent acute episodes of EIB. If you are a Mayo Clinic patient, this could The estimated exposure in mice was approximately 45 and 25 times the AUC for adults and children, respectively, at the maximum recommended daily oral dose. It decreases inflammation in your airways. include protected health information. Talk to your doctor or get medical care right away if: Montelukast may cause some people to be agitated, disoriented, irritable, or display other abnormal behaviors. The 10-mg film-coated tablet is recommended for use in patients 15 years of age. A safety study in pediatric patients 2 to 14 years of age with seasonal allergic rhinitis demonstrated a similar safety profile [see ADVERSE REACTIONS]. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Expert Panel Working Group of the National Heart, Lung, and Blood Institute (NHLBI) administered and coordinated National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC), et al. Some neuropsychiatric events may have been handled by discontinuation of the drug without a health care encounter. Animal studies showed that montelukast distributes into the brain in rats [see CLINICAL PHARMACOLOGY]; however, the mechanisms underlying SINGULAIR-associated NP events are currently not well understood. Use of SINGULAIR for this indication is supported by evidence from well-controlled studies. In pediatric patients 6 to 14 years of age, using the 5-mg chewable tablet, a 2-day crossover study demonstrated effects similar to those observed in adults when exercise challenge was conducted at the end of the dosing interval (i.e., 20 to 24 hours after the preceding dose). The .gov means its official.Federal government websites often end in .gov or .mil. SINGULAIR 4 mg Tablets: pink, oval, bi-convex-shaped chewable tablets, with code MSD 711 on one side and SINGULAIR on the other. The safety profile of SINGULAIR in a 6-week, double-blind, placebo-controlled clinical study was generally similar to the safety profile in adults and pediatric patients 2 to 14 years of age. 2001 Mar;56(3):244. doi: 10.1136/thorax.56.3.244. * Number of patients tested (SINGULAIR and placebo, respectively): ALT and AST, 1935, 1170; pyuria, 1924, 1159. Montelukast Tablets. Your or your child's symptoms do not improve after using this medicine or if they become worse. Signs of a common cold . It is indicated for patients 6 months and older: for the treatment of asthma as add-on therapy in those patients with mild to . The predictive ability of cough sound algorithms shows promise in detecting acute respiratory diseases, study finds. The site is secure. NP events have been reported in adult, adolescent, and pediatric patients with and without a previous history of psychiatric disorder. It is reasonable to employ appropriate clinical monitoring when potent CYP enzyme inducers, such as phenobarbital or rifampin, are co-administered with SINGULAIR. BMC Med. Effectiveness of SINGULAIR in this age group is extrapolated from the demonstrated effectiveness in patients 6 years of age and older with asthma based on similar mean systemic exposure (AUC), and that the disease course, pathophysiology and the drugs effect are substantially similar among these populations, supported by efficacy data from a safety trial in which efficacy was an exploratory assessment. AAAAI Urges Patients on Montelukast to Contact Their Healthcare Provider. Abstract. A wide variety of mental health side effects have been reported, including completed suicides. For patients with both asthma and allergic rhinitis, administer only one SINGULAIR dose orally once daily in the evening. Exposure to montelukast was significantly associated with a decreased risk of treated outpatient depressive disorder (overall hazard ratio [HR]: 0.91; 95% confidence interval [CI]: 0.89-0.93). The effect of SINGULAIR on eosinophils in the peripheral blood was examined in clinical trials. In drug interaction studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: oral contraceptives (norethindrone 1 mg/ethinyl estradiol 35 mcg), digoxin, and warfarin. SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. African American, Hispanic Individuals With Medicaid at Higher Risk of Uncontrolled Asthma. All the patients also received salbutamol and cetirizine as rescue medications. The types of inhaled corticosteroids and their mean baseline requirements included beclomethasone dipropionate (mean dose, 1203 mcg/day), triamcinolone acetonide (mean dose, 2004 mcg/day), flunisolide (mean dose, 1971 mcg/day), fluticasone propionate (mean dose, 1083 mcg/day), or budesonide (mean dose, 1192 mcg/day). In animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (MRHDOD) based on AUCs [see Data]. The efficacy of SINGULAIR tablets for the treatment of perennial allergic rhinitis was investigated in 2 randomized, double-blind, placebo-controlled studies conducted in North America and Europe. Adult and adolescent patients 15 years of age and older, one 4 mg chewable tablet or one packet of oral granules, Pediatric patients 12 to 23 months of age*. dry mouth. An official website of the United States government. Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with SINGULAIR for at least 3 months, 230 for 6 months or longer, and 63 patients for one year or longer in clinical trials. SINGULAIR is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Four suicides occurred (two exposed to montelukast, two exposed to ICS), all in patients older than 18 years with a psychiatric history. The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Efficacy and safety of sublingual immunotherapy with grass monomeric allergoid: comparison between two different treatment regimens. Phenobarbital, which induces hepatic metabolism, decreased the area under the plasma concentration curve (AUC) of montelukast approximately 40% following a single 10-mg dose of montelukast. Counsel all patients about mental health side effects and advise them to stop the medicine and contact a health care professional immediately if they develop any symptoms. The U.S. Food and Drug Administration (FDA) became aware of postmarketing reports of neuropsychiatric adverse events with Singulair (montelukast) use in 2007. Exercise challenge testing was conducted at 2 hours, 8.5 or 12 hours, and 24 hours following administration of a single dose of study drug (SINGULAIR 10 mg or placebo). The safety of SINGULAIR 4-mg oral granules in pediatric patients 12 to 23 months of age with asthma has been demonstrated in an analysis of 172 pediatric patients, 124 of whom were treated with SINGULAIR, in a 6-week, double-blind, placebo-controlled study [see ADVERSE REACTIONS]. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, or start to act reckless. information is beneficial, we may combine your email and website usage information with Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Sign up for free and stay up to date on research advancements, health tips, current health topics, and expertise on managing health. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). * Average of individual scores of nasal congestion, rhinorrhea, sneezing as assessed by patients on a 0-3 categorical scale. It is used to treat seasonal outdoor allergies in patients 2 years and older, and year-round indoor allergies in patients 6 months and older. [29630] A Boxed Warning was added to the montelukast prescribing information because of serious neuropsychiatric events and recommended that . There was a significant decrease in the mean percentage change in daily as-needed inhaled -agonist use (11.7% decrease from baseline in the group treated with SINGULAIR vs. 8.2% increase from baseline in the placebo group, p<0.05). The U.S. Food and Drug Administration (FDA) is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy. In vitro studies have shown that montelukast is a substrate of CYP 2C8, 2C9, and 3A4. The safety of SINGULAIR 4-mg oral granules in pediatric patients as young as 6 months of age with perennial allergic rhinitis is supported by extrapolation from safety data obtained from studies conducted in pediatric patients 6 months to 23 months of age with asthma and from pharmacokinetic data comparing systemic exposures in patients 6 months to 23 months of age to systemic exposures in adults. SINGULAIR contains aspartame, a source of phenylalanine. We are requiring a Boxed Warning, our most prominent warning, be added to the prescribing information to describe these serious mental health side effects. Lastly, the study was unable to adjust for socioeconomic status. The groups were homogeneous at baseline. Montelukast sodium is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The risk of inpatient depressive disorder associated with montelukast use compared to ICS was not significant (overall HR: 1.06; 95% CI: 0.90-1.24). Accessibility The other 6-week study evaluated SINGULAIR 10 mg (n=626), placebo (n=609), and an active-control (cetirizine 10 mg; n=120). official website and that any information you provide is encrypted If you have allergies, there are a number of steps you can take to lessen your symptoms. Similar results were shown at 24 hours post-dose (a secondary endpoint). Ann Acad Med Singap. angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, Stevens-Johnson syndrome/toxic epidermal necrolysis, urticaria, arthralgia, myalgia including muscle cramps. These activities have resulted in successive labeling updates and public communications. Efficacy of sublingual immunotherapy in asthma: systematic review of randomized-clinical trials using the Cochrane Collaboration method. On this episode of Managed Care Cast, a research scholar at the Marron Institute of Urban Management at New York University discusses the latest findings in the Health of the Air report, which was presented at the recent American Thoracic Society 2021 International Conference. We recognize that millions of Americans suffer from asthma or allergies and rely on medication to treat these conditions. The incidence of somnolence was similar to that of placebo in all studies. Other increases in reporting were due to duplicate reports or foreign reports. Respectfully submitted, It's usually an alternate or add-on treatment. Common side effects of montelukast include upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, earache or ear infection, flu, runny nose, and sinus infection. NDC 78206-171-01 unit of use carton with 30 packets. A web-based physical activity self-management intervention for chronic obstructive pulmonary disease (COPD) might be helpful for urban participants across 4 months, but not so much for rural participants. Four of the five trials showed a significant reduction in daytime nasal symptoms scores with SINGULAIR 10-mg tablets compared with placebo. The efficacy of SINGULAIR for the chronic treatment of asthma in adults and adolescents 15 years of age and older was demonstrated in two (U.S. and Multinational) similarly designed, randomized, 12-week, double-blind, placebo-controlled trials in 1576 patients (795 treated with SINGULAIR, 530 treated with placebo, and 251 treated with active control). Montelukast, a selective antagonist of the leukotriene D4 (LTD4) receptor, made its debut into our armamentarium in 1998 as an non steroid oral option for asthma in both children and adults. Some occurred during montelukast treatment and resolved after stopping the medicine. In March of 2020, FDA had issued black box warning for montelukast, due to its increasing evidences of serious neuro-psychiatric side effects. In many cases, symptoms resolved after stopping SINGULAIR therapy; however, in some cases symptoms persisted after discontinuation of SINGULAIR. The efficacy of SINGULAIR for the chronic treatment of asthma in pediatric patients 2 to 5 years of age was explored in a 12-week, placebo-controlled safety and tolerability study in 689 patients, 461 of whom were treated with SINGULAIR. However, a literature review did not reveal evidence that montelukast and ICS are prescribed disproportionally to patients of varying socioeconomic status. The frequency of less common adverse reactions was comparable between SINGULAIR and placebo. You shouldn't use this medication to treat a sudden asthma attack. Patients 15 to 82 years of age with perennial allergic rhinitis as confirmed by history and a positive skin test to at least one relevant perennial allergen (dust mites, animal dander, and/or mold spores), who had active symptoms at the time of study entry, were enrolled. x. Pharmacy product. SINGULAIR has been evaluated for safety in 175 pediatric patients 6 to 23 months of age. For the 5-mg chewable tablet, the mean Cmax is achieved in 2 to 2.5 hours after administration to adults in the fasted state. FOIA Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD4 in asthmatics. Do not take other medicines unless they have been discussed with your doctor. Thus, it was unable to evaluate either the entire spectrum of neuropsychiatric events or events that did not result in a billed encounter. Singulair may interact with phenobarbital or rifampin. FDA warning montelukast 03.2020-Statement of the Austrian working group of pediatric pulmonology and allergology. These are not all of the side effects that may occur. The magnitude of effect of SINGULAIR in aspirin-sensitive patients was similar to the effect observed in the general population of asthma patients studied. Check with your physician for additional information about side effects. By continuing to browse this site, you are agreeing to our use of cookies. In response to continued reports of suicide and other adverse events, the FDA evaluated available data regarding the risk of neuropsychiatric events, including reports submitted through the FDA Adverse Event Reporting System (FAERS) and observational studies in the published literature. Cumulatively, 569 patients were treated with SINGULAIR for at least 6 months, 480 for one year, and 49 for two years in clinical trials. However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of drugs primarily metabolized by CYP2C8) in 12 healthy individuals demonstrated that the pharmacokinetics of rosiglitazone are not altered when the drugs are coadministered, indicating that montelukast does not inhibit CYP2C8 in vivo. Most reported cases of neuropsychiatric events occurred during montelukast treatment, but some occurred after discontinuation. PMID: 28971612; PMCID: PMC5625152. Table 6: Effect of SINGULAIR on Primary and Secondary Endpoints in a Multinational Placebo-controlled Trial (ANOVA Model). On the basis of these concerns, the FDA embarked on another comprehensive review and also conducted a new observational study using claims data in the Sentinel Distributed Database. Risks associated with the drug may outweigh the benefits for some patients, particularly when symptoms are mild, then FDA said. Copyright: Merative US L.P. 1973, 2023. SINGULAIR oral granules can be administered without regard to the time of meals. Other reports indicated that mental health side effects developed or continued after stopping montelukast. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Published data from prospective and retrospective cohort studies have not identified an association with SINGULAIR use during pregnancy and major birth defects. Last updated on Jul 20, 2022. Clipboard, Search History, and several other advanced features are temporarily unavailable. PMC Allergic rhinitis; Asthma; Boxed warning; Exercise-induced bronchospasm; Leukotriene-modifying agents; Montelukast; Neuropsychiatric adverse events. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. the unsubscribe link in the e-mail. Discuss the benefits and risks of SINGULAIR use with patients and caregivers when prescribing SINGULAIR. The primary endpoint was the mean maximum percent fall in FEV1 following the 2 hours post-dose exercise challenge in all three studies (Study A, Study B, and Study C). Advise patients about the potential risk for serious neuropsychiatric symptoms and behavioral changes with SINGULAIR use [see, Discuss the benefits and risks of SINGULAIR with patients when prescribing or continuing treatment with SINGULAIR [see, Advise patients to monitor for changes in behavior or neuropsychiatric symptoms in patients taking SINGULAIR [see, Instruct patients to discontinue SINGULAIR and contact a healthcare provider immediately if changes in behavior or thinking that are not typical for the patient occur, or if the patient develops suicidal ideation or suicidal behavior [see, Advise patients to take SINGULAIR daily as prescribed, even when they are, Advise patients that oral SINGULAIR is not for the treatment of acute asthma attacks. In the study in which efficacy was demonstrated, the median age was 35 years (range 15 to 81); 64.1% were females and 35.9% were males. Additional Information for Patients and Parents/Caregivers, Additional Information for Health Care Professionals, The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective, Think It Through: Managing the Benefits and Risks of Medicines, Advisory Committees: Critical to the FDA's Product Review Process, agitation, including aggressive behavior or hostility, hallucinations (seeing or hearing things that are not really there). In another randomized, placebo-controlled, parallel-group trial (n=642) in a similar population of adult patients previously maintained, but not adequately controlled, on inhaled corticosteroids (beclomethasone 336 mcg/day), the addition of SINGULAIR to beclomethasone resulted in statistically significant improvements in FEV1 compared with those patients who were continued on beclomethasone alone or those patients who were withdrawn from beclomethasone and treated with montelukast or placebo alone over the last 10 weeks of the 16-week, blinded treatment period. Cyp enzyme inducers, such as phenobarbital or rifampin, are co-administered with SINGULAIR Medical Education and Research ( )! Foia the following adverse reactions was comparable between SINGULAIR and placebo prevent automated submissions... Including completed suicides and several other advanced features are temporarily unavailable a human visitor and to acute. 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