In March 2020, FDA has added a black box warning of mental illness to the popular asthma medication, Singulair. The FDA has received countless reports of potential psychiatric side effects including 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.
FDA Singulair Black Box Mental Illness 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. Also, 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 Singulair Lawsuit Consultation
Therefore, if you have experienced mental illness symptoms after taking Singulair, you may be eligible for compensation to offset your financial, physical, and emotional burdens. Contact us today to set up a free consultation during which we will listen to your story and discuss your legal rights and options. If you choose us to represent you, we will work with you on a contingency fee basis; this means you pay nothing until we have secured compensation for you, either through a jury verdict or settlement.