2004N-0330 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee

FDA Comment Number :

EC9

Submitter :

Ms. Catherine Fountain

Date & Time:

08/30/2004 02:08:55

Organization :

Ms. Catherine Fountain

Individual Consumer

Category :

Issue Areas/Comments

GENERAL

On October 9,1997, when my son was 12 years old, he tried to commit suicide by jumping out a fourth story window at school. A teacher stopped him. At that point he had fully intended to end his life. His suicide note however, indicated that he did not comprehend that this would be a final act. My son is intelligent, well liked and respected. He was president of the student council. When we asked why he would do this, he said something just came over him. When he realized later that he could have ended his life, he said in disbelief, "That wasn't me. I would never do anything like that".

There was no doubt in my mind that the Luvox he had begun taking recently for obsessive compulsive disorder was to blame for this behavior. I had noticed some uncharacteristic and disturbing behavior that he had displayed lately and I had suspected that the drug was to blame, after all, the drug was meant to act on behavior. He did not seem to have the worries that he had prior to taking Luvox, in fact, he seemed to be completely without fear. But he also seemed to have lost all awareness of consequence. He lost his ability to judge what was risky, dangerous, or hurtful. Previoulsy, I had even questioned his doctor about whether this drug could affect his judgment. The doctor told me that Luvox had no side effects. The pharmacy gave me a one page printout listing such benign side effects such as headache or nausea. When I did further research, I was furious when I discovered that suicideality was a potential side effect and that this information was kept from me! I had a right to know that something I was giving to my son could possibly kill him. Instead, we were led to believe that unless we chose the path of medication, we were doing something very wrong.

My son is a happy and successful college sophomore now. We do not look back at how that event affected our lives. (Many details of the horrors surrounding it are omitted here). It was a nightmare to put behind us - a lonely and difficult recovery, obviously not something we shared with family and friends. Over the past six years, I have struggled with how to balance my duty to warn others, with the damage I may cause to my son's privacy and peace of mind by publicly retelling his story. Every time I hear of another death due to the effects of an SSRI, I wonder if I could have done something more to make people aware of the dangers, if I could have possibly saved a life. This is why I am submitting this comment. And for every piece of anecdotal evidence that makes its way to this committee, know that there are countless other similar stories that go untold and undocumented, for this is not an easy side effect to deal with. Many parents blame themselves and block the horrible memories.

We who have seen our children transform before our eyes after taking an SSRI and then return when the medication is stopped know the drug is the cause. We don't need experts or studies or statistics. (Some of us still use deductive reasoning and common sense to figure things out).

Please use our experience to help prevent another needless loss of life and to spare families unbearable heartache. I know that we were one of the lucky ones, my son is still alive. And because he is alive and has his whole life ahead of him, I only ask that for his sake, our names are not published. Thank you.