Singulair Suicide, Depression Risks Draw Strong “Black Box” Warning from FDA

Federal regulators are adding stronger warnings about the potential psychiatric side effects of Singulair, requiring a “black box” indication that the asthma and allergy drug has been linked to reports of depression, suicidal behavior and other mental health risks.

In a drug safety communication issued on March 4, the FDA announced that the strongest label warning possible will be required for Singulair, featuring information in a prominent black box that includes data from a new review of an observational study, as well as ongoing adverse event reports involving mental side effects.

Following the recent review, the FDA has upgraded previous warnings about the Singulair risks to indicate that use of the drug may cause suicidal thoughts or actions, and warning that for some patients the risks may outweigh the benefits, especially if their asthma symptoms are mild.

Singulair (montelukast) belongs to a class of drugs known as selective leukotriene receptor antagonists. It is a pill taken orally once a day to treat asthma, exercise induced asthma and seasonal allergies. Singulair is recommended and prescribed regularly for both children and adults. 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.

“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” Dr. Sally Seymour, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “With today’s action, the FDA aims to make sure patients and medical providers have the information available to make informed treatment decisions. Importantly, there are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”

The FDA first required warnings about behavioral and suicide side effects of Singulair in 2009. However, this latest warning indicates the agency has continued to receive data on the problems, both from an observational study using data from the Sentinel Distributed Database, as well as ongoing reports submitted to the FDA Adverse Event Reporting System (FAERS). The agency presented its findings at an advisory committee meeting in September 2019.

The FDA identified 82 cases of “completed suicide” linked to Singulair use. The agency indicates that 45 of those cases involved patients older than 17 years old, 19 cases involved patients 17 years old or younger, and 18 cases where no age was indicated.

The FDA recommends that patients and parents or caregivers of child Singulair users stop using the drug and talk to a healthcare professional immediately if they see symptoms including:

• 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.

The FDA is asking health care professionals to consider the risks and benefits of Singulair before prescribing to new patients or continuing patients on the medication. The FDA warned doctors to inform patients of the potential mental health side effects and tell them to stop taking the drug if symptoms occur.

The agency also warned doctors to be aware that some neuropsychiatric events even after they’ve stopped taking the drug and urged them only to prescribe Singulair for allergic rhinitis patients if they have an inadequate response or intolerance to alternative therapies.

The FDA encourages health care professionals and patients to report any adverse events or side effects related to Singulair use to the FDA MedWatch Safety Information and Adverse Event Reporting Program.