Texas Allergy Experts
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THE FDA POSITION ON SINGULAIR       ( MONTELUCAST )

 

..  the FDA determined the risks of montelukast may outweigh the benefits in some patients, particularly when the symptoms of the disease are mild and can be adequately treated with alternative therapies. For allergic rhinitis in particular, the FDA has determined that montelukast should be reserved for patients who have not responded adequately to other therapies — or who cannot tolerate these therapies.”

 

 I

 have had the discussion a couple times 

recently. I mention that there’s a black box 

warning from the FDA that has come to our 

attention. It is difficult for me because on one

 hand this medication has been shown to be 

safe down to six months of age and is 

pregnancy category B -data showing safety in

 pregnant women. At the same time there’s 

aftermarket reporting of psychiatric issues.

 


.                                            Since these symptoms generally go                                                away with cessation of the drug.  I                                                  still think it’s a reasonable                                                                medication to use, certainly in                                                          asthma, but should be promptly                                                      stopped if there any concerns for                                                    sleep disturbance, night terrors, or                                                  mood dysregulation. It is could be                                                    the Singulair. 

 


 

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