Have you suffered a mental health event after taking Singulair? It is crucial that anyone who has experienced severe mental health issues after taking the asthma drug Singulair or any of its generic formulations 1) seek proper medical care, and 2) speak with an attorney who has substantial knowledge in the area of dangerous drug litigation.  

Singulair lawsuits are currently being researched.  Initiating a lawsuit action against a powerful and profitable pharmaceutical company likely sounds intimidating. If you retain the right lawyer, such a claim can result in you being paid monetary damages, and the drugmaker being held accountable for the harm caused.

Sections in this article:

• Singulair Receives Boxed Warning
• Are There Lawsuits Against Singulair?
• What You Should Know About Singulair Lawsuits
• Potential Monetary Damages That Could be Recovered in Singulair Lawsuits
• Singulair Use and Wrongful Death
• What Is Singulair Used For and How Does it Work?
• FDA History with Singulair
• Potential Scope
• Manufacturers of Singular and its Generics
• What Mental Health Conditions Have Been Linked to Singulair?
• Are You a Concerned Singulair User?  Next Steps
• Seek Experienced Legal Advice

In March 2020, the United States Food and Drug Administration (FDA) began requiring a boxed warning on Singular, and its generic forms of the medication, Montelukast. A boxed warning is the FDA’s strongest warning and bolsters an already existing FDA warning regarding the risks of neuropsychiatric events that could occur with the use of the medicine. 

The FDA warnings are worrisome to patients who have taken Singulair, or who have a loved one who uses the medicine.  If you are in this situation, please continue reading, as this article addresses some of the key points related to the FDA warnings and potential lawsuits against Singulair manufacturer Merck and manufacturers of Singulair’s generic formulations.

Lawsuits related to the use of Singulair and resulting adverse mental health events are currently being researched.  If you or someone you love one has experienced psychiatric or mental health issues after using Singulair, you probably have a lot of questions about the process involved with pursuing a lawsuit against a giant pharmaceutical corporation.  

How could I benefit by pursuing a personal injury lawsuit due to mental health harm caused by the use of Singulair?

• You may receive financial recovery for the health harm caused by your use of Singulair and for pain and suffering that the health condition caused.
• Your spouse, if applicable, may be entitled to monetary compensation for the negative effects the mental health condition had on your marriage.
• Consumers need to hold dangerous drugmakers responsible for the harm their products cause.
• Dangerous drug lawsuits can trigger changes to larger policies, which may help keep consumers safer and could save lives in the future.
• Not only is there a potential for individual benefit, but there may also be a beneficial societal change that happens when consumers that were harmed by a dangerous product bravely pursue action against the negligent drug corporations.

Monetary damages available in a personal injury claim against Singulair are dependent upon a number of factors, one of which is the seriousness of the injuries that use of the medication caused the plaintiff (the injured person).

Other factors that play into how much may be recovered in a personal injury dangerous drug lawsuit are:

• The plaintiff’s current health conditions that were caused by the use of the medication.
• The plaintiff’s health prognosis and whether future medical treatment is necessary.
• The effects the health conditions had on the quality and enjoyment of life for the plaintiff.
• The effects the health conditions had on the plaintiff’s marital relationship.
• The effects the health conditions had on the plaintiff’s past and future ability to make a living.

A claim for wrongful death falls within the category of a personal injury matter.  The plaintiffs in a wrongful death matter are the heirs of the deceased person – most often a spouse, parent, or child/children.  A Singulair wrongful death action could be the remedy for family members that endured the death of a family member due to a Singulair-related suicide.

Montelukast, the active ingredient in Singulair and its generic formulations, works to block leukotrienes within the body, which helps to improve asthma symptoms as well as symptoms of allergic rhinitis (hayfever). It is used to prevent difficulty breathing, wheezing, coughing, and chest tightness from asthma, and to treat nasal symptoms such as a runny nose and sneezing related to hay fever.

The FDA has been reviewing data related to reports of neuropsychiatric events associated with the use of Singulair for more than 10 years. These events include depression, agitation, insomnia, and suicidal ideation and completion.  Singulair’s product labeling was updated by the FDA in 2008 to include information about reported neuropsychiatric events.  

In 2014, Merck & Co. (Merck), the manufacturer of Singulair, requested FDA approval for over-the-counter (OTC) sales for treatment of allergy symptoms in adults. Public Citizen, a consumer advocacy organization, argued successfully that Singulair was too hazardous to be sold OTC and had minimal benefits with potentially serious health risks. The proposed Singulair OTC sales were banned by the FDA  in May 2014.

The FDA orchestrated an observational study, and in 2019 gave the findings to an FDA advisory meeting.  It was determined that for some patients, the risks of Singulair and its generics could outweigh the benefits, especially when the drug was being used for mild symptoms that could be treated with other therapies.  

In addition to the new boxed warning required as of March 2020, the FDA also now requires a Medication Guide be given with each Singulair/montelukast prescription.

As many as 24 million allergy and asthma patients, some as young as one year old, are taking Singulair and potentially risking severe mental health side effects. In 2019, prescription Singulair pulled in $698 million for Merck. Over 9 million patients (approximately 2.3 million of whom were younger than 17 years old) received a prescription for Singulair or its generics In 2018.

Multi-billion dollar pharmaceutical company Merck & Co. brought Singulair to the market in 1998.  In 2012, the FDA approved generic forms of the drug.  Other manufactures include, but are not limited to: 

• Ajanta Pharma LTD
• Dr. Reddy’s Labs LTD
• Accord Healthcare
• Teva Pharms
• Aurobindo Pharma LTD
• Torrent Pharms LTD
• Anbison Lab
• Aurobindo Pharma LTD
• Cipla
• Hikma
• Unimark Remedies LTD
• Amneal Pharms
• Glenmark Generics
• Herero Labs LTD
• Unichem Labs LTD
• Macleods Pharms LTD
• Sandoz Inc.

The FDA has identified side effects of Montelukast that include suicidal ideation (thoughts) and actions. Other mood or behavior-related changes include:

• Agitation, which can include hostility or aggressive behavior
• Anxiety
• Attention issues
• Confusion or disorientation
• Depression
• Hallucinations
• Irritability
• Memory deficits
• Obsessive-compulsive behavior
• Restlessness
• Shaking or tremor
• Sleep disruption including sleepwalking
• Stutter
• Uncontrollable muscle movements
• Vivid nightmares or dreams

The FDA has investigated instances of completed suicides among Montelukast users.  Many had reported neuropsychiatric symptoms before the suicide was completed. 

The neuropsychiatric side effects were present in people who had prior mental health issues, in addition to those without a mental health history. Even after discontinuing the medication, some patients had continuing effects.

The FDA evaluated the risks and benefits of Singulair and issued the statement that the medication should not be the first treatment choice, especially in cases of allergic rhinitis symptoms, for which there are many other effective and safe medications.  Numerous other allergy medications have an extensive history of use and safety, and many are available without a prescription.

If you are taking Singulair and are concerned about the risks, contact your prescribing physician.

Anyone who has experienced adverse mental health events after taking Singulair should seek medical and/or psychiatric care immediately to provide a thorough history of their use of Singulair and the mental health events suffered since taking the drug.

The FDA has issued warnings about adverse mental health events related to Singulair use for many years.  The drug manufacturers were well aware of the dangers and yet continued to market and sell the drug.  The drug companies made an enormous amount of money from the sales of Singulair and its generic formulations. Those same drug companies will use that money to vigorously defend any lawsuit brought against them for damages caused by Singulair. 

There are numerous challenges associated with these types of lawsuits, and it is crucial that anyone who has suffered a serious mental health event after taking Singulair finds an attorney with considerable experience in claims against pharmaceutical companies.

Below is a CBS news clip reporting on the recent upgraded FDA warnings for Singulair.

If you or a family member have experienced psychiatric or mental health issues following the use of Singulair or one of its generics, call our law firm for free, friendly, and compassionate advice at (916) 921-6400 or (800) 404-5400. An online contact form is available here if you prefer.

We are proud to be part of the Million Dollar Advocates Forum and the National Association of Distinguished Counsel.

Reviews from prior clients are accessible at Google, Yelp, and Avvo. Please have a look at our verdicts and settlements as well.

DISCLAIMER: This document is for informational purposes only and does not constitute a Retainer or Agreement for Services.  No attorney-client relationship will exist between you and our law firm unless and until a signed Retainer/Services Agreement is entered into. The information presented at this site is not, nor is it intended to be legal or medical advice.  Never stop taking any prescribed medication without first consulting your doctor.

^{Image by Charles Thompson from Pixabay :mm llo [cs 1668]}