As reported in the Associated Press, the FDA just announced that it had completed its analysis of Singulair for suicide, and found absolutely no link.
"Regulators said that only one in nearly 10,000 patients taking Singulair in clinical trials reported suicidal tendencies. No patients committed suicide."
I blogged about this when the FDA announced it was going to look into the matter back in March. I am no fan of Singulair (see here ), but was extremely skeptical of this link given the relatively clean safety profile of singulair, the lack of biologic plausibility, and the fact since millions of patients with allergies and asthma take Singulair (which is unfortunate, because it doesn't work all that well and extremely expensive), if there was a really link it would've shown up by now.
I have no problem with the FDA investigating concerns with medications. This is what they are supposed to do. The problem I have is that they report the fact that they are investigating a problem, without any data or information to be informative to doctors or patients. I raised these concerns when the FDA initially proposed this strategy. There is a reason that in the United States a person is presumed innocent until found guilty. Because of our 24/7 media cycle and their desire to publish scary stories about medicine, when the FDA announces it is looking into a medication, this automatically makes headlines. Patient and physicians, being provided limited to no data as well as no clinical context, assume the worst. Many patients will simply stop taking a medication, without even informing their doctor.
Please recall that though the Vioxx scandal was one of the first events to put the spotlight on the FDA, the Avandia scare magnified this. As I have mentioned multiple times, well done studies on Avandia (see here ) have not led to the same conclusion as Dr. Nissen's poorly done meta-analysis. The ramifications of that dreaded publication by the New England Journal of Medicine have been numerous and include decreasing the availability of newer drugs for diabetes, guidelines which push patients onto insulin sooner, and the FDA needlessly worrying the public about safe (though ineffective) medications with these early warnings of investigations.