Allergy & Asthma Associates

SINGULAIR - 3/31/2008

Statement Regarding FDA Investigation of Singulair (March 28, 2008) On March 27, 2008 the Food and Drug Administration announced an investigation into a possible link between Singulair and behavior/mood changes, suicidal thoughts and suicide. This follows an update last fall by Merck, the manufacturer of Singulair, to include these mood-related issues in the prescribing information for the drug. Singulair is an effective medicine that has been widely prescribed for the past ten years for treatment of asthma. Within the past few years it has also found a role in the treatment of nasal allergies. Few, if any, medications prescribed in the field of allergy, asthma and immunology have had such stellar safety track records. We at Allergy and Asthma Associates estimate that patients for whom we have prescribed Singulair number in the thousands, with ages spanning one year to seventy years or more. No case has led to concerns regarding serious mood disturbance, such as suicidal thought. The concern by the FDA is based entirely on case reports. There is no conclusive evidence that suicidal thought or suicide is an extremely rare side effect of the medicine or (more likely) a simple but potentially tragic chance association. The FDA estimates it will take up to nine months to complete the ongoing evaluations, following which the agency will make its final recommendations to the medical community and the public. Based on all the millions of patient-years of use of Singulair in this and other countries around the world, our personal professional experience with this medicine, and the new FDA pronouncement, it is strongly advised that patients taking Singulair should continue to take the medication as prescribed provided: (1) you and we feel the medication is serving its desired purpose and (2) it is free of side effects, including any suggestion of mood change such as suicidal thought. Our recommendations herein are consistent with the formal position statements recently brought forth by our two major professional societies, the American Academy and the American College of Allergy, Asthma and Immunology. Persons experiencing suicidal thoughts or demonstrating suicidal behavior should seek medical consultation immediately. Since it is unlikely that Singulair is truly the source of such serious mood disorders, one should never assume the problem will resolve by simply stopping the drug. Stopping Singulair without medical guidance runs the obvious risk of exposing the patient to unstable asthma and all that that entails. Please contact us if you have any questions about this matter, and do not abruptly discontinue your medicine. Drs. Banks and Andrews

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