855.846.6529 tmiles@timmileslaw.com

Singulair (montelukast) is a drug prescribed to patients suffering from asthma or severe allergies that can provide symptom relief and help them manage their condition. It is a very successful drug for its manufacturer, Merck & Co. Singulair received the U.S. Food & Drug Administration’s (FDA) marketing approval in 1998; by 2004, Singulair was doing $2.62 billion in sales

But by 2009, there were concerns that Singulair may have an adverse effect on its users’ mental health. That year, the FDA updated its potential side effect warning about Singulair to include the potential for “neuropsychiatric events.” 

The FDA warned that the potential adverse mental health symptoms could include: ”postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.”

These concerns have only grown over time — in March 2020, the FDA began requiring a “black box” warning label (the FDA’s highest danger advisory) on every unit of Singulair, warning of the potential for severe mental health symptoms, including suicidal ideation and attempted suicide. 

In light of these mounting concerns, the FDA now advises against the use of Singulair to treat seasonal or chronic allergies, except in cases where no other medication works for that specific patient. 

Merck & Co. is now facing lawsuits from Singulair users who allege that the medication caused them to experience adverse mental health symptoms, including suicidal ideation. If you or a loved one have taken singulair and experienced suicidal ideation or other adverse mental health symptoms, you may be eligible for compensation

How Was The Risk Discovered?

The FDA based their new warnings and recommendations on Singulair-associated neuropsychiatric incidents that were reported to the FDA’s Sentinel Initiative, as well as animal studies and reports of suicides. 

The FDA identified 82 cases where a sucide was linked to montelukast. Forty-five cases involved a patient older than 17, 19 involved one younger than 17, and 18 case reports did not indicate the patient’s age. 

A study of montelukast in mice found the drug molecule inside the brain, indicating that the drug can cross the blood-brain barrier. This would suggest that montelukast/Singulair could enter and harm the brain as well. 

The combination of all this information caused the FDA to update their assessment of the possible risks posed by taking Singulair. 

What Symptoms Are Linked To Singulair?

A wide range of adverse mental health symptoms have reportedly been experienced by Singulair users. These include:

  • Suicidal thoughts, potentially escalating to suicidal ideation and attempted suicide 
  • Insomnia
  • Nightmares 
  • Anxiety 
  • Increased aggression 
  • Restlessness 
  • Irritability
  • Memory issues 
  • Sleepwalking 
  • Depression 
  • Lack of focus and reduced ability to concentrate 
  • Body tremors

 If you or a loved one has experienced any of these symptoms, you may have grounds for a lawsuit against the drug manufacturer. 

Should I Stop Taking Singulair?

You should talk to your doctor about your options before making any changes. The FDA has expressed concerns that not all doctors and healthcare providers are currently aware of the updated understanding of Singulair’s risk profile, so make sure that your doctor knows about the March 2020 FDA update

Am I Eligible For A Singulair Lawsuit?

If you or a loved one took Singulair and has since experienced any of the above adverse mental health symptoms, you may be eligible for a lawsuit. If successful, you could win compensation for any financial losses incurred due to your symptoms, including medical costs, as well as damages for pain and suffering. 

Injured By Singulair? We Can Help 

If you or a loved one is suffering from adverse mental health symptoms after taking Singulair, you may be eligible for compensation. We are ready to review your case for free, and if we take your case, you won’t pay anything up front; you won’t pay at all unless we win for you.