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In your August 2020 article “Recent FDA Safety Warnings About Schizophrenia Drug Clozapine, Asthma/ Allergy Drug Montelukast,” you noted that the risks of montelukast (SINGULAIR) outweigh its benefits for asthma and allergic rhinitis. Do the risks of the drug outweigh the benefits when it is used for chronic obstructive pulmonary disease (COPD)?
The Food and Drug Administration (FDA) has approved montelukast only for the treatment of asthma, exercise-induced bronchoconstriction and...
In your August 2020 article “Recent FDA Safety Warnings About Schizophrenia Drug Clozapine, Asthma/ Allergy Drug Montelukast,” you noted that the risks of montelukast (SINGULAIR) outweigh its benefits for asthma and allergic rhinitis. Do the risks of the drug outweigh the benefits when it is used for chronic obstructive pulmonary disease (COPD)?
The Food and Drug Administration (FDA) has approved montelukast only for the treatment of asthma, exercise-induced bronchoconstriction and allergic rhinitis. The FDA has not approved the drug for the treatment of COPD, nor are we aware of any large, well-designed, randomized, placebo-controlled clinical trials that demonstrate that montelukast is safe and effective for such an off-label use. We therefore advise against using montelukast for COPD.
