A groundbreaking revelation by the U.S. Food and Drug Administration (FDA) has spotlighted significant mental health risks associated with Montelukast, a widely prescribed asthma and allergy medication. Known under the brand name Singulair and as generics, Montelukast has been found to bind to brain receptors linked to psychiatric functions, raising concerns for millions of patients globally.
Why This Matters for Indian Pharmacists
Montelukast is a staple in Indian pharmacies, commonly prescribed for asthma and allergic rhinitis. Indian pharmacists are often the first point of advice for patients. Understanding these new concerns enables pharmacists to:

• Advise Cautiously: Alert patients about potential mental health side effects, especially if they report unusual symptoms like anxiety, depression, or mood changes.

• Ensure Compliance: Encourage customers to discuss concerns with their doctor before discontinuing the medication, avoiding abrupt changes that might worsen their condition.

What the FDA Found
The FDA’s internal research showed that Montelukast binds to multiple brain receptors associated with mood, cognition, and sleep. This could explain the growing reports of neuropsychiatric side effects, including depression, anxiety, and suicidal thoughts. Alarmingly, 82 suicides since 1998 have been linked to the drug, with 31 involving individuals under 19 years old.

• How It Was Discovered: Laboratory tests confirmed Montelukast’s presence in rat brains, with high concentrations in regions governing psychiatric functions.

• Real-World Impact: Cases like Robert England’s son, a healthy 22-year-old who tragically died within days of starting the drug, underline the gravity of these findings.

What Pharmacists Should Know

1. Existing Label Warnings: Since 2020, Montelukast carries a “black box” warning—the FDA’s strictest advisory—highlighting risks of suicidal thoughts and actions.

2. Pharmacist’s Role: While the FDA hasn’t updated the label following this new research, pharmacists should proactively inform patients and healthcare providers about the potential risks.

3. Advise Patients: Encourage reporting of adverse mental health symptoms and reinforce the importance of medical supervision.

The Big Picture
This development is part of a larger global trend prioritizing patient safety. Drugs like Montelukast have long been trusted staples, but evolving research demands vigilance and adaptability from healthcare providers.
Indian pharmacists, being trusted advisors in their communities, are uniquely positioned to ensure the safe and informed use of such medications. With mental health awareness on the rise, this is an opportunity to demonstrate care and build trust.