In March 2020, FDA added stronger warnings about the potential psychiatric side effects of Singulair, an asthma and allergy drug. Studies have linked the medication to reports of depression, suicidal behavior, and other mental health risks.
About Singulair
Singulair (montelukast) is a class of drugs of selective leukotriene receptor antagonists. Patients take an oral pill daily to treat asthma or seasonal allergies. Both children and adults can take Singulair. The manufacturer indicates common side effects include stomach pain, diarrhea, fever, flu-like symptoms, stuffy nose, sinus pain, or headache. Other side effects may include skin rashes, ear pain or swelling, severe tingling, and changes in mood or behavior. However, the box does not mention any mental side effects.
Singulair Black Box Warning
In a drug safety communication issued on March 4, 2020, the FDA announced a black box warning (the strongest label warning possible) for Singulair after a new review of an observational study by the Sentinel Distributed Database. Plus, the agency has received many adverse event reports involving the mental side effects. These risks may outweigh the benefits of alleviating asthma symptoms.
In 2009, the FDA first gave Singulair a warning about behavioral and suicide side effects after receiving 82 cases of “completed suicides” linked to the medication’s use. The agency indicates that 45 of those cases involved patients older than 17 years old. Also, there were 19 cases of patients 17 years old or younger, and 18 cases without an age.
Singulair Mental Illness Symptoms
The common Singulair mental illness symptoms are:
- Agitation and aggressive behavior
- Attention problems
- Bad or vivid dreams
- Depression
- Disorientation or confusion
- Anxiety
- Hallucinations
- Irritability
- Memory problems
- Obsessive-compulsive symptoms
- Restlessness
- Sleepwalking
- Stuttering
- Suicidal thoughts or actions
- Tremors
- Sleeping problems
- Uncontrolled muscle movements.
Free Consultation
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. A verdict or settlement may give you compensation for your injuries and damages. The types of recoverable losses are:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
Also, if a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
Therefore, if a jury finds the conduct of a drug company in manufacturing and selling a drug to be highly reckless, they may award punitive damages. These can punish the company and deter similar conduct in the future. If you developed suicidal thoughts or mental illness after taking Singulair, please speak to us to learn more about your rights.
Learn More
FDA Adds a Black Box Warning of Mental Illness to Asthma Medication Singulair