March 5, 2020 — The FDA is strengthening warnings about depression and suicide from the allergy drug Singulair (generic: montelukast).
In a Drug Safety Communication on March 4, the FDA said it will require a “Black Box” warning label — the strongest possible warning — about the risk of depression and suicide from Singulair.
The FDA identified 82 completed suicides associated with Singulair in a study of adverse events. The risk of suicide may outweigh the benefits of Singulair, especially for people with mild asthma symptoms, according to the FDA.
The agency is warning doctors not to prescribe Singulair to patients with mild symptoms, particularly allergic rhinitis (hay fever).
The FDA is warning patients and parents of children on Singulair to stop taking it and contact a healthcare professional immediately if they experience symptoms of behavior or mood-related changes, such as:
- Agitation, aggressive behavior, hostility
- Attention problems
- Bad or vivid dreams
- Disorientation or confusion
- Memory problems
- Obsessive-compulsive symptoms
- Suicidal thoughts and actions
- Tremors or shakiness
- Trouble sleeping
- Uncontrolled muscle movements.
Dr. Sally Seymour of the FDA’s Center for Drug Evaluation and Research said in a press release that stronger warnings were necessary because many patients and doctors were not fully aware of the risk of neuro-psychiatric events with Singulair, such as agitation, depression, sleeping problems, and suicidal thoughts and actions.
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The Schmidt Firm, PLLC is currently accepting Singulair induced injury cases in all 50 states. If you or somebody you know has been diagnosed with depression or suicidal behavior, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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