FDA Warns About Suicidality with use of Singulair

Today the FDA published an “early communication” regarding the drug Singulair which is used to treat asthma and allergies. According to the FDA, there is indication that taking of this drug might lead to suicidal thinking and behavior, otherwise known as “suicidality”. Here is a drug meant for asthma and allergies and it is causing people to think about killing themselves?!? This is out of control.
I have handled several cases over the last many years involving children and adolescents who have been prescribed anti-depressants such as Paxil and Prozac and killed themselves. I have to tell you, there is no more difficult case to deal with on a personal level than a client who’s young innocent child has decided to take their own life. The usual defense raised by the phamaceutical companies is that it was the disease i.e. depression, not the drug which lead the child to kill him or herself. In the cases I handled I was able to successfully show to the pharmaceutical companies that these children were never diagnosed clinically depressed, but instead were prescribed the medication by the family physician because the child was “going through a rough patch” i.e. adolescents. The doctors were lead to believe by the pharmaceutical companies that these anti-depressants were “safe” and promoted the drugs to be used to help those who are feeling “down in the dumps”. This was despite the fact the drug was approved by the FDA to be prescribed for diagnosed depression. Thus, I was able to show that there was nothing else which could have caused the child to take the desperate act of suicide but the drug itself.
With Singulair, a drug prescribed for allergies and asthma, Merck, the manufacturer cannot claim the disease called the patient to take his own life. Should be interesting to see how Merck explains this one. Clearly, a patient taking a drug for allergies isn’t expecting to feel suicidal. One thing I would say is it appears the FDA is trying to get information out there to the public on safety concerns alot quicker. I have to commend them for that. According to the FDA’s website, Merck changed the adverse events on the package insert (what you generally get from the pharmacy when you pick up your prescription) on this drug in October 2007 to include suicidality concerns. They are working with Merck to figure out how to publicize this to the public and to doctors. It has been almost 6 months since they changed the package insert on this drug and they are still trying to figure out how to publicize this to doctors????? Something as significant as potential for suicide ??? Things that make you go “Hmmmm????”