As winter chills settle in, allergies often spike, leading many to seek relief. Montelukast, a common allergy medication, helps manage symptoms by reducing inflammation and blocking histamines. But is it the best choice for you? Learn about its benefits, side effects, and when it’s most effective for allergy control.
Montelukast is primarily used for the management of asthma or relief of symptoms associated with allergic rhinitis. It is not intended for daily use.
The cool breeze in the mornings can aggravate symptoms of allergic rhinitis. Many affected may experience sneezing, runny noses, and itchy eyes. In India, one in five people suffers from allergic rhinitis.
When symptoms flare up, many people turn to a combination tablet of Montelukast and Levocetirizine for quick relief. But is it a good idea to take pop this pill whenever symptoms arise?
Dr Visweswaran Darisetty, a Hyderabad-based pulmonologist is not impressed with the regular intake of the pill. “Montelukast is primarily used for the management of asthma or relief of symptoms associated with allergic rhinitis. It is not intended for daily use,” he said.
Recently, Montelukast, commonly prescribed for allergies and asthma, has come under scrutiny due to its potential mental health risks, including depression and suicidal thoughts.
Widely used in India as part of combined treatments with antihistamines for seasonal allergies, Montelukast’s safety profile has raised global concerns, sparking caution among healthcare professionals.
The case of Harry Miller
Fourteen-year-old Harry Miller, a bright British teenager, managed asthma with prescribed medications like many young people. Montelukast, one of these medications, was intended to help him breathe easier and manage his allergies.
But over the two years he took it, Miller experienced severe anxiety and depression—feelings far too heavy for his young shoulders.
In February 2018, after enduring these mental health challenges, Harry took his own life. His devastated family sought answers and began to suspect that Montelukast might have contributed to his mental health decline.
They shared his story, and soon, his experience became a symbol of the urgent need to examine Montelukast’s risks more closely.
As more cases emerged, highlighting neuropsychiatric side effects of Montelukast—ranging from mood changes to thoughts of self-harm—the US Food and Drug Administration issued a black box warning for the drug, followed by similar warnings from the UK health authorities.
Sadly, Miller’s story isn’t unique. “One of my students used to have terrible nightmares after taking this drug. He didn’t know about the adverse effects initially but eventually connected the dots. Awareness is the key, and I think, as doctors, we owe this to our patients,” Mumbai-based pulmonologist Dr Lancelot Pinto said on X.
The risk and boxed medicines
Every month, when the Central Drugs Standard Control Organisation (CDSCO) releases its drug alert, various Montelukast combinations are often flagged as “Not of Standard Quality” (NSQ).
This frequent occurrence suggests that Montelukast is both popular and widely available across India, supplied in various formulations to meet high demand throughout the country.
Originally developed as a leukotriene receptor antagonist, Montelukast works by blocking substances that trigger inflammation in the body.
Clinical studies support its effectiveness in managing allergic rhinitis (AR) and seasonal allergies, and its convenience often makes it an attractive choice over inhaled corticosteroids.
However, recent findings have revealed potential neuropsychiatric side effects, including depression, aggression, and anxiety.
These risks have prompted regulatory agencies like the US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to issue stronger warnings.
The FDA recently added a boxed warning—the agency’s most severe—highlighting the risk of severe mood and behavior changes, including suicidal ideation, associated with Montelukast.
Regulators now recommend reserving Montelukast for patients unresponsive to other treatments. While the drug remains effective for allergy management, these risks, especially for young patients, may sometimes outweigh its benefits.
Dr Satyanarayana Mysore, a pulmonologist and head of Sleep Medicine at Manipal Hospitals in Bengaluru, said the warning was not new.
“The FDA has recently strengthened it, and the context here is important,” he said. He noted that the warning was informed by two studies: the Sentinel study and patient self-reported questionnaires, both showing higher incidences of neuropsychiatric issues among Montelukast users.
“The boxed warning is the FDA’s most serious type, intended to make consumers aware of significant risks associated with the drug,” he added.
Dr. Ravi Mehta, a pulmonologist at Apollo Hospital, Bengaluru said Montelukast, a common drug, has been effective for recurrent, persistent moderate asthma and allergies, used in both paediatric and adult cases.
“It’s part of standard treatment guidelines from various allergy and asthma societies. However, like any medication, it requires weighing the risk-benefit ratio,” he said.
Dr Mehta explained that its long-term use, though relatively rare, has been associated with neuropsychiatric side effects such as mood changes, insomnia, depression, and suicidal thoughts.
He emphasised that while the drug remained safe for most patients, it required careful monitoring.
“The key takeaway is that no drug is without risk. Montelukast has clear benefits, but it should be prescribed to the right patients, with monitoring for any side effects. The drug should be stopped if adverse effects are observed,” he advised.
Despite concerns, Montelukast has been widely prescribed in India, often in combination with Levocetirizine, an antihistamine. Its oral form and ease of use make it popular, especially among children.
However, the mental health implications are sometimes overlooked, highlighting a need for greater awareness and caution in its use.
What’s the alternative?
Montelukast has alternatives, particularly ones that steer clear of the neuropsychiatric side effects Montelukast can bring.
First, Inhaled Corticosteroids (ICS) are the backbone of asthma management. They offer long-term control by directly addressing inflammation in the lungs.
“Options like Fluticasone—available as Flomist and Flixonase—and Budesonide, found in Budecort and Pulmicort, are popular choices. We also have Beclomethasone, which comes as Beclate. For those needing a combination with a bronchodilator, Seretide (a mix of fluticasone and salmeterol) and Symbicort (budesonide with formoterol) are effective options,” Dr Darisetty said.
He said when it came to Antihistamines, especially for mild allergic rhinitis, drugs such as Cetirizine (Cetzine, Alerid), Levocetirizine (Xyzal, Levozet), Fexofenadine (Allegra, Fexodine), and Loratadine (Lorfast, Loridin) were frequently used.
These are generally well-tolerated and effective for symptoms like sneezing and a runny nose, though they may need to be combined with other medications for full asthma control.
For those primarily experiencing nasal symptoms, Nasal Corticosteroids like Fluticasone Propionate (Flomist, Nasacort) and Mometasone Furoate (Nasonex, Metaspray) are good alternatives. These are applied directly to the nasal passages, allowing for effective symptom control without systemic side effects.
But he warned that every treatment has its advantages and specific considerations, including side effects, cost, and availability.
“Patients must consult their healthcare providers to determine the best course of action based on their unique needs, where they should communicate their side effects of Montelukast to the physician, and to ensure they’re monitored carefully throughout their treatment,” Dr Darisetty said. #hydkhabar
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