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Singulair Suicide, Depression Risk Get FDA “Black Box” Warning

Singulair Suicide, Depression Risk Get FDA “Black Box” Warning

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
  • Depression
  • Disorientation or confusion
  • Anxiety
  • Hallucinations
  • Irritability
  • Memory problems
  • Obsessive-compulsive symptoms
  • Restlessness
  • Sleepwalking
  • Stuttering
  • 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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