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Psychiatric Side Effects Linked to Singulair, Similar Meds | cialis online

Psychiatric Side Effects Linked to Singulair, Similar Meds

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Federal health regulators are warning that Singulair (montelukast ) and  similar asthma medications have been linked to psychiatric side effects, including suicidal behavior.  The Food & Drug Administration announced Friday that the prescribing information of these drugs – known as leukotriene modifiers  – will  carry a new precaution about these side effects.  In addtion to Singulair, the new precaution will be included in the prescriging information of   Accolate (zafirlukast)  and Zyflo and Zyflo CR (zileuton).

The agency said on Friday that  doctors and their patients should be aware that  mental issues could arise in patients taking leukotriene modifiers and consider discontinuing the drugs if patients develop psychiatric symptoms.  Patients should speak with their doctors if they experience any neuropsychiatric symptoms.

The FDA has been investigating reports of psychiatric side effects – including agitation, aggression, suicidal thinking, suicide, depression, insomnia and irritability – associated with Singulair since March 2008.  As part of its review, the FDA reviewed post-marketing reports and also requested that manufacturers submit all available clinical trial data for the medications. The agency completed its  safety review this past April.

According to the FDA,  the post-market reports of patients on  Singulair and similar drugs included cases of neuropsychiatric events.  Some reports included clinical details consistent with a drug-induced effect. In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed, the FDA said.  However, according to the agency, the available data were limited because the trials were not designed to look for neuropsychiatric events.   Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo.

Leukotrienes are chemicals the body releases in response to an inflammatory stimulus, such as when a person breathes in an allergen.  Singulair and Accolate are  leukotriene receptor antagonists that work by blocking 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.  All of the drugs are approved to treat asthma, while Singulair is also  approved to treat the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma.

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