Singulair, Other Asthma Drugs Asked to Warn of Mood-Change Risks
The Food and Drug Administration is asking the makers of asthma drugs called leukotriene modifiers to warn users about the risks of severe behavioral and mood changes they may suffer from while taking the drugs.
Singulair (montelukast), Accolate (zafirlukast), and Zyflo/Zyflo CR (zileuton) are covered by the FDA request. The companies that make the drugs are being asked to include in the drugs’ prescribing information a new precaution section about neuropsychatric events which have been reported in some people taking the medications.
Consumers using the drugs to control their asthma have suffered from agitation, depression, insomnia, and suicidal thoughts, officials said. The FDA is cautioning that “patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.”
Singulair is made by Merck and was approved by the FDA in 1998. It is a top-selling drug which earned Merck $4.3 billion in sales in 2008. Singulair is approved to treat asthma and allergies in children and adults. Accolate and Zyflo also are approved as asthma treatments.
Earlier FDA Action on Singulair
In 2008, the FDA launched a safety review of Singulair after patients complained of suffering behavioral and mood changes while taking the drug. The FDA asked Merck and the makers of Accolate and Zyflo to provide the agency with more clinical trial information on the drugs.
Leukotrienes are chemicals the body releases 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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