The FDA has declared that asthma drugs are not related to suicide risk. After reviewing the data for nine months, the agency has come to a conclusion that there is no association between the respiratory drugs and suicide.
The FDA has thus, declared that Singulair, Accolate, Zyflo, or Zyflo CR are safe and no danger to a person's psyche is associated with them.
But the FDA is still reviewing data on how the asthma drugs that affect leukotriene pathway cause any influence on behavior or mood of the patient.
The FDA studied data from 41 clinical trials of Singulair, 45 clinical trials of Accolate, and 11 trials of zileuton (the active ingredient in Zyflo and Zylfo CR) to come to conclusion about the safety of these drugs. Each of those drugs was compared to a placebo.
It was found that there was only one case of suicidal thinking in 9,929 patients taking Singulair. In comparison, there was one suicide and one case of suicidal thinking in the placebo group in the Accolate trials. But there were no such case zileuton trials.
"We have finished our analyses of all the data the companies submitted," said FDA spokeswoman Karen Riley. "But that doesn't mean we have closed the book on suicidality."
In an online statement, The FDA declared that it would continue reviewing possible associations between mood and behavioral disorders and the drugs. This could take many months before the agency could come to any conclusion.












