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Box of Singulair/Montelukast Prescription Medication

Do you or a loved one take Singulair (generic name is Montelukast) for asthma or allergies? Earlier this year, the U.S. Food and Drug Administration (FDA) acknowledged serious mental health side effects related to this popular medicine, prescribed to over 35 million people. The side effects include suicidal thoughts or actions, agitation, hallucinations, and depression. Since March 2020, the medication now requires a Black Box warning, due to the overwhelming evidence of serious mental health side effects.

According to A Guide to Drug Safety Terms at FDA, a black box warning “appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.” Medline Plus, a website operated by the U.S. National Library of Medicine, has the following information about Singulair/Montelukast:

Montelukast may cause serious or life-threatening mental health changes while you are taking this medication or after treatment has stopped. You should call your doctor right away and stop taking montelukast if you experience any of the following symptoms: agitation, aggressive behavior, anxiety, irritability, difficulty paying attention, memory loss or forgetfulness, confusion, unusual dreams, hallucinations (seeing things or hearing voices that do not exist), repeating thoughts that you cannot control, depression, difficulty falling asleep or staying asleep, restlessness, sleep walking, suicidal thoughts or actions (thinking about harming or killing yourself or planning or trying to do so), or tremor (uncontrollable shaking of a part of the body). Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

~ National Institutes of Health

If someone you know takes Singulair/Montelukast, encourage them to contact their doctor to discuss whether they should continue taking the medication.

Benefits vs. Risks
Medicine, whether over-the-counter (OTC) or prescription, has side effects. In the best case scenario, the benefits of any drug should outweigh the side effects. However, the FDA found that the benefits of Singulair/Montelukast often did not outweigh the risks.

To educate yourself about the side effects/adverse reactions of any FDA-approved medication, visit DailyMed, a website maintained by the National Institutes of Health (NIH). To help you make the best decisions related to your health, read Think It Through: Managing the Benefits and Risks of Medicines, a guide written by the FDA.

Report Adverse Reactions
If you or a loved one have taken Singulair/Montelukast and have experienced any adverse reactions, you are encouraged to make a report to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. To do this, visit MedWatch to submit a report online or to download a reporting form.

Written by: Laura Stanton, MA, MS, Family and Consumer Sciences Educator, Ohio State University Extension, Warren County, stanton.60@osu.edu.

Reviewed by: Shari Gallup, MS, CHWC, Family and Consumer Sciences Educator, Ohio State University Extension, Licking County, gallup.1@osu.edu.

Sources:
DailyMed- Singular/Montelukast: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8c166755-7711-4df9-d689-8836a1a70885#S5.1

FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis; Risks may include suicidal thoughts or actions: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug

Finding and Learning about Side Effects (adverse reactions): https://www.fda.gov/drugs/drug-information-consumers/finding-and-learning-about-side-effects-adverse-reactions

A Guide to Drug Safety Terms at FDA: https://www.fda.gov/media/74382/download

MedlinePlus- Singulair/Montelukast: https://medlineplus.gov/druginfo/meds/a600014.html

National Institutes of Health: https://www.nih.gov

Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning – Due to Restricting Use for Allergic Rhinitis: https://www.fda.gov/safety/medical-product-safety-information/singulair-montelukast-and-all-montelukast-generics-strengthened-boxed-warning-due-restricting-use

Think It Through: Managing the Benefits and Risks of Medicines: https://www.fda.gov/drugs/drug-information-consumers/think-it-through-managing-benefits-and-risks-medicines

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Woman holding head
Do you ever feel like a hamster in the wheel just spinning around and around? Or like the world around you is always demanding something more from you? Life has a way of swallowing us up if we don’t manage our schedules. As I look at my monthly calendar, I feel overwhelmed by doctor’s appointments, volleyball games, meetings and more meetings, evening work programs, my daughter’s high school homecoming, house repairs, conference presentations, deadlines, webinars, family obligations, and traveling out of town for work 15 out of 26 days. 

As part of my job, I encourage people to practice healthy time management and stress management. Clearly, I have fallen victim to NOT practicing what I preach. I would like to say without hesitation, that I have not experienced first-hand how life responsibilities and demands can quickly create feelings of stress. That would be a lie. I am keenly aware of the warning signs and symptoms related to increased stress in my life. Like many people, I sometimes choose not to listen to my body’s cues.

Headaches and muscle tension are symptoms I experience when I am overwhelmed. The Cleveland Clinic identifies these other physical symptoms related to stress:

  • Dizziness or a general feeling of “being out of it.”
  • General aches and pains
  • Grinding teeth, clenched jaw
  • Headaches
  • Indigestion or acid reflux symptoms
  • Increase in or loss of appetite
  • Muscle tension in neck, face, or shoulders
  • Problems sleeping
  • Racing heart
  • Cold and sweaty palms
  • Tiredness or exhaustion
  • Trembling/shaking
  • Weight gain or loss
  • Upset stomach and/or diarrhea
  • Sexual difficulties

Do you know how stress affects you? I encourage you to take some time to identify the signs and symptoms you experience related to stress. Once you know your own warning signs, it will be easier to manage stress. There are a variety of ways to cope with stress.  The key is choosing what works for you and what fits your lifestyle. The Mayo Clinic offers these stress management tips:

  • Get regular physical activity
  • Practice relaxation techniques, such as deep breathing, meditation, yoga, tai chi, or massage
  • Keep a sense of humor
  • Spend time with family and friends
  • Set aside time for hobbies, such as reading a book or listening to music

If you practice healthy stress management techniques but your symptoms continue or worsen, please seek assistance from a healthcare professional. If you or a loved one is having thoughts of suicide, call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255). It is available to anyone. 24 hours a day, 7 days a week and all calls are confidential.

Written by: Lorrissa Dunfee, Family and Consumer Sciences Educator, OSU Extension Belmont County, dunfee.54@osu.edu

Reviewed by: Misty Harmon, Family and Consumer Sciences Educator, OSU Extension Perry County, harmon.416@osu.edu

References:

https://my.clevelandclinic.org/health/articles/11874-stress

https://www.mayoclinic.org/healthy-lifestyle/stress-management/in-depth/stress-symptoms/art-20050987

Photo Source: https://pixabay.com/photos/clause-law-flood-stress-burnout-3213670/

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