FDA Investigating Singulair

The FDA has announced it is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior), and suicide. Although Singulair is not a drug directly associated with chronic pain, because it is so frequently prescribed for allergies and asthma, I feel it’s important to share this alert with you. Specifically, Singulair is a leukotriene receptor antagonist used to treat allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and asthma. It is also used to prevent exercise-induced asthma.

Over the past year, Merck & Co., Inc., the manufacturer of Singulair, has updated both the prescribing and patient information to include the following possible adverse events or side effects: tremor, depression, suicidality and anxiousness. The FDA is currently reviewing reports it has received of behavior/mood changes, suicidality and suicide related to Singulair. They have also asked Merck to evaluate the Singulair study data for more information about suicidality and suicide. Because of the complexity of the analysis, the FDA anticipates it may take up to nine months to complete the evaluations.

Other leukotrien modifying medications the FDA is reviewing include: Accolate, Zyflo and Zyflo CR. The FDA urges both patients and healthcare professionals to report side effects from any of these drugs to the FDA MedWatch Adverse Event Reporting program.

If you take Singulair, Acolate, Zyflo or Zyflo CR and have noticed any changes in your mood or behavior, or if you have had suicidal thoughts, contact your doctor right away. The FDA recommends, however, that you do not stop taking the medication before talking with your doctor. After talking with your doctor, be sure to report your side effects to the FDA.

You can report your adverse event to the FDA:

• On-line at www.fda.gov/medwatch/report.htm.
• By returning the postage-paid FDA form 3500 [available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787.
• By faxing the form to 1-800-FDA-0178.
• By phone at 1-800-332-1088.

Read the full FDA communication about Singulair.