Singulair, Other Asthma Drugs Get Updated Warnings
Singulair and other brands of asthma drugs called leukotriene inhibitors now carry updated warnings about mood changes and other neuropsychiatric events reported in users, the Food and Drug Administration said.
The brand name drugs and their generic equivalents included in the FDA’s updates to the precautions section of the products’ prescribing information are:
• Singulair (montelukast)
• Accolate (zafirlukast)
• Zyflo and Zyflo CR (zileuton)
The FDA first announced it would be strengthening the warnings section of the drugs’ prescribing information in June. The agency had been conducting a safety review of leukotriene inhibitors and found the drugs should include more explicit and complete warnings about the risk of severe mood changes in some users.
The changes to the prescribing information have now been made, the FDA said.
Singulair and the other drugs treat asthma symptoms by blocking substances in the body called leukotrienes. It is not a steroid, but Singulair is approved for treating asthma and the prevention of exercise-induced asthma and allergic rhinitis.
Leukotrienes are chemicals released by the body in response to an inflammatory stimulus, such as when a person breathes in an allergen, the FDA said. Singulair and Accolate are leukotriene receptor antagonists that block leukotrienes.
Zyflo and Zyflo CR are leukotriene synthesis inhibitors which work by stopping the formation of certain substances that cause swelling, tightening, and mucus production in the airways, the FDA said.
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